1. Art and Diseño

Gloreha (Hand Rehabilitation Glove):
summary of clinical results
February 2015 – Revision C
Although Gloreha (Hand Rehabilitation Glove) is a new device, its effectiveness has
already been verified thanks to some clinical trials which involved:
 post-stroke patients in the sub-acute phase (up to a maximum of 90 days
after the event; MAS≤3)1,2,3,4,5;
 post-stroke patients in the chronic phase (MAS≤3)6,7,8,9,10,11,12;
1
Vanoglio F., Luisa A., Garofali F., Mora C.; Evaluation of the effectiveness of Gloreha (Hand Rehabilitation Glove) on
hemiplegic patients. Pilot study; presented at XIII Congress of Italian Society of Neurorehabilitation, 18-20 April 2013,
Bari (Italy).
2
Parrinello I., Faletti S., Santus G.; Use of a continuous passive motion device for hand rehabilitation: clinical trial on
neurological patients; presented at the 41st National Congress of Italian Society of Medicine and Physical
Rehabilitation, 14-16 October 2013, Rome (Italy).
3
Montecchi M.G., Volta B., Tettamanzi S., Pederzini E., Lombardi F.; Effectiveness of the hand treatment with Gloreha
rehabilitation glove on post-stroke patients after focal cerebral ischemia: randomized trial, with cross-over design;
presented at the 42nd National Congress of the Italian Society of Physical and Rehabilitative Medicine, 28 September-1
October 2014, Turin (Italy).
4
Molteni F., Mulè C., Caimmi M., Taveggia G., Missud S., Bianchi P.; Use of continuous passive motion device for the
hand on post-stroke patients: pilot study. Presented at the 39th National Congress of Italian Society of Medicine and
Physical Rehabilitation, 16-19 October 2011, Reggio Calabria (Italy).
5
Bissolotti L., Gobbo M., Gaffurini P., Orizio C., Changes in Skeletal Muscle Perfusion on Patients with Post-stroke
Hemiparesis Treated by Robotic Assistance (Gloreha) of Hand: A Case Series; submitted to the 9th World Congress of
the International Society of Physical and Rehabilitation Medicine, 19 - 23 June 2015, Berlin (Germany).
6
Bissolotti L., Robotic rehabilitation of the upper limb after stroke: analysis of peripheral vascular adaptations during
Gloreha treatment; presented at XIV Congress of Italian Society of Neurorehabilitation, 8-10 May 2014, Genova (Italy).
7
Bissolotti L., Symptomatic treatment with Gloreha after stroke: effects on pain and spasticity; presented at XIV
Congress of Italian Society of Neurorehabilitation, 8-10 May 2014, Genova (Italy).
8
Bissolotti L., Gobbo M., Gaffurini P., Orizio C., Changes in Spasticity on Patients with Post-stroke Hemiparesis Treated
by Robotic Assistance (Gloreha) of Hand: A Case Series; submitted to the 9th World Congress of the International
Society of Physical and Rehabilitation Medicine, 19 - 23 June 2015, Berlin (Germany).
1
 post-stroke patients treated with botulinum toxin13,2,11;
 post-stroke patients with hemispatial neglect (right-hemisphere brain
damage due to first-ever ischemic stroke; MAS<3)14,15,2;
 hemiparetic patients after neuro-oncological surgery (hand function deficit;
MAS≤3)16;
 other neurological patients: patients affected by multi-neurite, traumatic
brain injury, meningioma of the spinal cord2;
 patients affected by musculoskeletal diseases17.
Clinical results and scientific evidences about Gloreha were presented on scientific
journals and/or during National and International Rehabilitation Conferences. For
example:
 Journal of NeuroEngineering and Rehabilitation: Varalta V, Picelli A, Fonte C,
Montemezzi G, La Marchina E, Smania N, Effects of contralesional robot9
Bissolotti L., Gobbo M., Gaffurini P., Orizio C., The perceived effectiveness after Gloreha treatment in patients with
stroke: a comparison with Physical Therapists judgment; submitted to the 9th World Congress of the International
Society of Physical and Rehabilitation Medicine, 19 - 23 June 2015, Berlin (Germany).
10
Gastaldo M., Azzolin I., Gobbi M., Re A., Vrenozi H., Minuto A., Rolle S., Campagnoli M., Massazza G., Use of the
robotic device Gloreha (Hand Rehabilitation Glove) for rehabilitation treatment of a patient affected by brachial
hemiparesis after stroke: case report; presented at 42nd National Congress of the Italian Society of Physical and
Rehabilitative Medicine, 28 September-1 October 2014, Turin (Italy).
11
Rolle S. (supervisor: Massazza G.), Conditions for the use of robotic hand in hemiplegic patients; doctoral dissertation
2014, Università degli Studi di Torino (Italy).
12
Vanoglio F., Mulè C., Bernocchi P., Salvi L., Galli T., Luisa A., Taveggia G., Gloreha project for telerehabilitation: a
home rehabilitation device for patients with hand deficits; presented at 42nd National Congress of the Italian Society of
Physical and Rehabilitative Medicine, 28 September-1 October 2014, Turin (Italy).
13
Stagno D., Baricich A., Invernizzi M., Grana E., Cisari C.; Use of a robotic device in the rehabilitation treatment after
botulinum toxin (type A) injection on spastic upper limb after stroke. Pilot study; presented at XIII Congress of Italian
Society of Neurorehabilitation, 18-20 April 2013, Bari (Italy).
14
Varalta V, Picelli A, Fonte C, Montemezzi G, La Marchina E, Smania N; Effects of contralesional robot-assisted hand
training in patients with unilateral spatial neglect following stroke: a case series study; J Neuroeng Rehabil. 2014 Dec
5.
15
Varalta V., Smania N., Geroin C., Fonte C., Gandolfi M., Picelli A., Munari D., Ianes P., Montemezzi G., La Marchina E.;
Effects of passive rehabilitation of the upper limb with robotic device Gloreha on visual-spatial and attentive
exploration capacities of patients with stroke issues; presented at Congress “Riabilitazione: una scienza in cammino”,
18-20 March 2013, La Villa (Bolzano - Italy) and XIII Congress of Italian Society of Neurorehabilitation, 18-20 April
2013, Bari (Italy).
16
Rodigari A, Zancan A, Jedrychowska I, Springhetti I; Evaluation of the effectiveness of Gloreha (Hand Rehabilitation
nd
Glove) on hemiplegic patients. Pilot study; Proceedings of the 42 National Congress of the Italian Society of Physical
and Rehabilitative Medicine, Edizioni Minerva Medica, in course of printing.
17
Bissolotti L., Gobbo M., Gaffurini P., Orizio C., The use of Gloreha Idrogenet in the clinical setting: a retrospective
analysis of 18 months experience; submitted to the 9th World Congress of the International Society of Physical and
Rehabilitation Medicine, 19 - 23 June 2015, Berlin (Germany).
2
assisted hand training in patients with unilateral spatial neglect following
stroke: a case series study;
 Proceedings of the 42nd National Congress of the Italian Society of Physical
and Rehabilitative Medicine: Rodigari A, Zancan A, Jedrychowska I,
Springhetti I, Effectiveness of the treatment of hemiplegic patient's hand with
robotic rehabilitation glove “Gloreha”: preliminary results;
 Congresses of Italian Society of Neurorehabilitation;
 World Congress of the International Society of Physical and Rehabilitation
Medicine.
Here are some conclusions of the clinical trials carried out on Gloreha:
 «We retrospectively evaluated the clinical experience in the use of Gloreha.
80 patients (mean ± SD age: 50.1±17.1 years) were extracted from the
Gloreha database of 18 months use. (…) Patients were affected by a Central
Nervous System (stroke, brain injury) in 69.2% of the cases, in 4.2% by
Peripheral Nervous System, in 6.7% by Spinal Cord Injury and in 9% by
musculoskeletal injury. (…) In clinical setting Gloreha can be used for a wide
range of upper limb disabilities. Dropout rate is negligible and determined
exclusively by severe spasticity. Gloreha showed high mechanical resistance
along with time»17.
 «Unlike other types of conventional physical therapy, the Gloreha machine
allows to initiate at the bedside early treatment with a high number of
repetitions of passive movement sequences in combination with real-time 3D
animation of hand movements shown on a monitor positioned in the patient’s
contralesional visual field (extrapersonal space)»14.
 «At the end of Gloreha glove training, preliminary results indicate that
patients with hemiplegia occurred after brain tumour removal show that a
visible improvement in upper limb function, motor skills of the hand and
dexterity, without pain. (…) The Gloreha glove can be a satisfying integration
of the standard rehabilitation treatment»16.
 «Gloreha seems to be suitable as a device to control spasticity, also after
Botox injection. The mobilization performed by the device induced a
reduction of muscle tone of hand and wrist in about the half of the
patients»11.
 «Our findings indicate that robot-assisted left (contralesional) hand training
may improve not only visuospatial exploration and attention but also speed
3
to execute gross movement of the arm, hand and fingers, as well as fingertip
dexterity in stroke patients with hemispatial neglect»14.
 «According to our data we can assume that, in the hand treatment, the device
Gloreha is not inferior to the standard treatment, that requires the presence
of physiotherapists. (…) It is evident that the use of Gloreha in a rehabilitation
program allows to increase considerably and, at a limited cost, the time of
treatment of the hand in hemiplegic patients, without increasing the efforts
by physiotherapists»1.
 «At the end of the rehabilitation treatment with the robotic glove Gloreha we
noted: reduction of hypertonia, improvement of grip, ROM, functional skills of
hemiparetic upper limb and quality of life perceived by the patient. The
treatment was performed with a high level of patient’s compliance. We think
that the advantageous cost-benefit ratio and the high levels of compliance,
safety and satisfaction make Gloreha a valuable rehabilitation solution,
complimentary with conventional approaches for cerebrovascular patients»10.
 «In the treatment of hand paralysis after stroke, robot-assisted mobilization
with Gloreha is generally positively rated by patients and, compared to
physical therapists, a good agreement is existing about the potential
functional benefit on mobility, pain and stiffness improvement»9.
 «We split 32 sub-acute post-stroke patients in two groups: a group was
treated with Gloreha (15 sessions, 30 minutes per session), the control group
was treated in a conventional way (15 sessions, 30 minutes per session). Both
groups showed a significant improvement of functional recovery and motor
capabilities and a reduction of pain, but the group treated with Gloreha
achieved better results in terms of Barthel Index, quickDASH, Motricity Index
and VAS (for pain assessment)»18.
 «We applied Gloreha on sub-acute patients with flaccid flexors and spastic
patients treated with Botox injection. In both cases, Gloreha treatment was
successfully included in an integrated rehabilitation approach, composed of
mobilization and electrical stimulation of fingers extensors. We are also
combining Gloreha with tDCS, according to protocols under study»19.
 «The patients liked the home treatment with Gloreha and performed the
rehabilitation sessions with a high level of compliance. Our experience shows
an interesting chance to continue the rehabilitation treatment after the
hospital discharge, in order to improve the integration between hospital and
community»12.
18
Taveggia G.; Gloreha: more intensive and effective rehabilitation, at hospital and home; Tecnologie Riabilitative 2014
November 3.
19
Molteni F.; Gloreha gives post-stroke rehabilitation a helping hand; Tecnologie Riabilitative 2014 September 2.
4
In particular, here are the clinical benefits recorded during the trials:
 Gloreha can increase grip and pinch strength on the paretic side of
neurological patients in the sub-acute phase.
Gastaldo et al., 2014. The case report is related to a chronic patient affected by hemiparesis (stroke occurred
8 months before the first Gloreha session). The patient was treated with Gloreha for 4 weeks (5 sessions per
week, 25 minutes per session). During the therapy, Gloreha glove mobilized the fingers while the patient
followed the movement on the screen thanks to the 3D simulation. After 4 weeks a significant improvement
of strength was verified, as shown in the chart below.
5
4
4
4
3
4
3
3
3
3
3
2
2
MRC
Before the treatment
2
1
1
After the treatment
1
0
Wrist flexors
Flexor
Flexor
digitorum digitorum
superficialis profundus
Thumb
flexors
Fingers
extensors
Pinch I-II
Vanoglio et al., 2013. The group treated with Gloreha developed a higher increment of the strength at the
Grip and the Pinch test in comparison with the control group. The treatment consisted of 30 sessions; the
duration of each session was 40 minutes. The patients included in the control group were treated by
therapists for the same time as the group treated with Gloreha.
120%
113.29%
100%
78.32%
80%
72%
60%
Group treated with
Gloreha
40%
Control group
20%
13.87%
0%
Grip test
Pinch test
5
 Gloreha can improve functional independence of neurological patients,
especially in the sub-acute phase.
Rodigari et al., 2014. The clinical trial is involving hemiparetic patients after neuro-oncological surgery. The
treatment with Gloreha consists of 20 sessions; the duration of each session is 60 minutes. The charts below
show the preliminary results related to 12 patients (p<0.001): at the end of the treatment, the FIM mean gain
(Delta) is 23.44 points (from 68.78 to 92.22), while the mean improvement of the motor subscore is 22.66
points (from 38.56 to 61.22). Taking into account the items of the upper limb (personal care: eating,
grooming, bathing, dressing, toileting) the mean delta is 9.77 points (from 17.67 to 27.44). The trial is still in
progress and also a control group will be enrolled to confirm the preliminary findings.
Parrinello et al., 2013. The treatment with Gloreha consisted of 10 daily sessions (30 minutes per session);
the patients started the treatment at least 3 weeks since the neurological event. All the 12 recruited patients
showed an improvement in functional independence, assessed by FIM.
Gastaldo et al., 2014. The case report is related to a chronic patient affected by hemiparesis (stroke occurred
8 months before the first Gloreha session). The patient was treated with Gloreha for 4 weeks (5 sessions per
week, 25 minutes per session). During the therapy, Gloreha glove mobilized the fingers while the patient
followed the movement on the screen thanks to the 3D simulation. After 4 weeks a significant improvement
of functional independence was verified, as shown in the charts below.
6
100
80
80
60
80
52
60
40
30
43
40
20
20
0
T0 (Wolf Motor
Function Test)
T1 (Wolf Motor
Function Test)
0
T0 (Barthel Index)
T1 (Barthel Index)
Vanoglio et al., 2013. The randomized controlled clinical trial involved 10 post-stroke patients in the subacute phase. The group treated with Gloreha showed a marked average increase evaluated by FIM
(Functional Independence Measure) Scale, against a substantial stability in the control group. The treatment
consisted of 30 sessions; the duration of each session was 40 minutes. The patients included in the control
group were treated by therapists for the same time as the group treated with Gloreha. IRCCS Maugeri
Foundation in Lumezzane (Italy) and Habilita Clinic in Sarnico (Italy) are applying the same protocol on further
patients, in order to make the sample bigger and get more solid results.
80
70
60
50
40
30
20
10
0
75.8
46.8
46.6
50.2
Before the treatment
After the treatment
Group treated with
Gloreha
Control group
7
 Gloreha can improve unimanual and bimanual coordination and dexterity of
neurological patients, especially in the sub-acute phase.
Rodigari et al., 2014. The clinical trial is involving hemiparetic patients after neuro-oncological surgery. The
treatment with Gloreha consists of 20 sessions; the duration of each session is 60 minutes. Bimanual
dexterity is assessed with Box and Block Test; the chart below shows the preliminary results related to 12
patients: they show a statistically significant improvement (p=0.044), from 20.22 (range: 0-55) to 27.56
(range: 0-62). The trial is still in progress and also a control group will be enrolled to confirm the preliminary
findings.
60
50
40
27.56
30
20.22
20
10
0
T0 (Box and Block Test average)
T1 (Box and Block Test average)
Varalta et al., 2014. Three right-handed patients with right-hemisphere brain damage due to first-ever
ischemic stroke were recruited and treated with Gloreha. Each patient underwent a training program
consisting of 10 sessions; the duration of each session was 30 minutes. Gloreha was used to perform a robotassisted left (contralesional) hand training. During the first week of treatment, the subjects had to watch the
monitor in front of them and name the fingers being moved throughout the training session, while during the
second week of treatment they had to name the moving fingers with their eyes closed.
The Purdue Pegboard test was used to assess gross movement of the arm, hand and fingers, as well as
fingertip dexterity. All patients showed improved performance (100%, 27.3% and 75% change n the
left+right+both hands sub.item score).
50
45
40
35
30
25
20
15
10
5
0
Purdue Pegboard Test (left+right+both hands)
28
22
Before the treatment
14
After the treatment
8
6
3
Patient A
Patient B
Patient C
Gastaldo et al., 2014. The case report is related to a chronic patient affected by hemiparesis (stroke occurred
8 months before the first Gloreha session). The patient was treated with Gloreha for 4 weeks (5 sessions per
week, 25 minutes per session). During the therapy, Gloreha glove mobilized the fingers while the patient
followed the movement on the screen thanks to the 3D simulation. After 4 weeks a significant improvement
of upper limb functioning was verified, as shown in the charts below.
8
50
40
30
25
20
14
10
0
T0 (Action Research
Arm Test)
T1 (Action Research
Arm Test)
Vanoglio et al., 2013. The evaluation of unimanual (paretic and healthy limb) and bimanual coordination and
dexterity shows averages of delta t1-t0 (t1: after the treatment; t0: before the treatment) in the group
treated with Gloreha higher than in the control group. The patients were post-stroke in the sub-acute phase.
The treatment consisted of 30 sessions; the duration of each session was 40 minutes. The patients included
in the control group were treated by therapists for the same time as the group treated with Gloreha.
0.3
0.245
0.25
0.2
0.15
0.138
Group treated with Gloreha
0.1
Control group
0.0496
0.05
0.0159
0.00382
0
-0.05
-0.02
Nine Hole Peg Test Nine Hole Peg Test Pennsylvania bi(healthy side)
(paretic side) manual worksample
Varalta et al., 2013. At the pre-treatment evaluation, after 4 months since hemorrhagic stroke, the patient
F.M. had high difficulty in using the left hand to perform exercises that require good capacities of manual
dexterity. After the treatment with Gloreha, the patient showed an improvement in both tests (Purdue
PegBoard Test and Nine Hole Peg Test). The treatment was made up of 10 rehabilitation sessions of 25
minutes.
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
0.72
0.58
0.24
0.14
Nine Hole Peg Test
(healthy side)
Before the treatment
After the treatment
Nine Hole Peg Test
(paretic side)
9
 Gloreha can increase the motricity (active movement) of neurological
patients.
Rodigari et al., 2014. The clinical trial is involving hemiparetic patients after neuro-oncological surgery. The
treatment with Gloreha consists of 20 sessions; the duration of each session is 60 minutes. The chart below
shows the preliminary results related to 12 patients. Motricity Index average data show a statistically
significant progression (p=0.036), from 34.78 (range: 0-72) to 47.56 (range: 0-76). The trial is still in progress
and also a control group will be enrolled to confirm the preliminary findings.
100
80
60
47.56
34.78
40
20
0
T0 (Motricity Index - average) T1 (Motricity Index - average)
Gastaldo et al., 2014. The case report is related to a chronic patient affected by hemiparesis (stroke occurred
8 months before the first Gloreha session). The patient was treated with Gloreha for 4 weeks (5 sessions per
week, 25 minutes per session). During the therapy, Gloreha glove mobilized the fingers while the patient
followed the movement on the screen thanks to the 3D simulation. After 4 weeks a significant improvement
of active movement was verified, as shown in the charts below.
100
66
80
60
56
72
43
46
49
36
40
26
20
16
23
6
0
T0 (Motricity Index)
T1 (Motricity Index)
-4
T0 (Fugl-Meyer)
T1 (Fugl-Meyer)
Vanoglio et al., 2013. The patients treated with Gloreha increased their motricity performance (Motricity
Index) both on the paretic side and the healthy one more than the patients included in the control group. The
treatment consisted of 30 sessions; the duration of each session was 40 minutes. The control group was
composed of patients treated by the therapist for the same time as the group treated with Gloreha.
92.7 94.4
100
78.54
72.4 75.9
80
60.2
60
40
15
20
23.9
Before the treatment
After the treatment
0
Group treated
with Gloreha
(healthy side)
Control group
(healthy side)
Group treated
with Gloreha
(paretic side)
Control group
(paretic side)
10
 Gloreha can decrease or prevent the hypertonia of neurological patients.
Bissolotti et al., 2015. The clinical trial involved 11 chronic post-stroke patients (at least 6 months after the
event; mean age 62.8±12.7 years). They received mobilization of the hand through the Gloreha device for 3
weeks (30 minutes per day, 3 sessions per week). Robotic intervention reduced spasticity after intervention
by 75% in wrist and fingers (1.4±1.1 at T0; 0.4±0.6 at T1; p<0.05).
Rolle, 2014. The clinical trial involved 16 hemiplegic patients (onset-admission range: 9-324 months). 14
patients were also treated with Botox injection before starting the Gloreha protocol. 6 patients underwent 20
Gloreha sessions, 10 patients underwent 10 Gloreha sessions (28 minutes per session, 5 sessions per week).
The charts below show the MAS values, before and after treatment, patient by patient. The first chart is
related to the muscle tone of wrist flexors: 31,25% of the patients showed a decrease, 68,75% didn’t show
any change, no one showed an increment of spasticity. The second chart is related to flexor digitum
profundus: 43,75% of the patients showed a decrease, 50% didn’t show any change, just in one case the tone
slightly increased (1 point on MAS). The last chart is related to flexor digitum superficialis: 43,75% of the
patients showed a decrease, 56,25% didn’t show any change, no one showed an increment of spasticity.
Wrist flexors
Flexor digitum profundus
Flexor digitum superficialis
11
Bissolotti et al., 2014. The clinical trial was carried out on 11 chronic patients after stroke (onset-admission
interval: 96.3±125.1 months). The treatment with Gloreha consisted of 10 daily sessions; the duration of each
session was 30 minutes. The researchers assessed significant clinical benefits in terms of muscle tone
reduction. The chart below shows the results collected at T0 (before the first treatment session with
Gloreha), T1 (after the first treatment session with Gloreha), T2 (before the last treatment session with
Gloreha), T3 (after the last treatment session with Gloreha).
Modified Ashworth scores
4,0
T0
T1
T2
T3
3,5
Ashworth scores
3,0
2,5
2,0
1,5
1,0
0,5
0,0
Wrist ext.
Fingers ext.
Gastaldo et al., 2014. The case report is related to a chronic patient affected by hemiparesis (stroke occurred
8 months before the first Gloreha session). The patient was treated with Gloreha for 4 weeks (5 sessions per
week, 25 minutes per session). During the therapy, Gloreha glove mobilized the fingers while the patient
followed the movement on the screen thanks to the 3D simulation. After 4 weeks a significant reduction of
spasticity was verified, as shown in the chart below.
2
MAS (Modified
Ashworth Scale):
2
Before the treatment
1
1
After the treatment
1
0
Wrist flexors
Flexor digitorum
superficialis
Flexor digitorum
profundus
Varalta et al., 2013. The post-stroke patient B.M. in the chronic phase (35 months after the event) showed a
lower level of spasticity of the fingers after the treatment with Gloreha (from MAS=2 to MAS=1). The
treatment consisted of 10 sessions (25 minutes per session).
Vanoglio et al., 2013. The tone of patients treated with Gloreha didn’t evolve into spasticity or, in a few
cases, just a slight increase of spasticity was recorded. The clinical trial involved post-stroke patients in the
sub-acute phase: they were treated 40 minutes for 30 days.
Stagno et al., 2013. 8 post-stroke patients in the chronic phase showed a decrease in spasticity after 1 week
and 1 month since the injection of BoNT-A (botulinum toxin type A) and the start of treatment with Gloreha.
12
4
3.7
3.5
3
2.5
2
1.5
Before the treatment
1.5
1.4
After 1 week
After 1 month
1
0.5
0
Finger flexors MAS
13
 Gloreha can reduce the oedema of neurological patients.
Montecchi et al., 2014. The clinical trial involved 23 patients after stroke. It was a randomized trial, with
cross-over design. The treatment with Gloreha consisted of 5 daily sessions; the duration of each session was
42 minutes. The outcomes verified the effectiveness of Gloreha for oedema reduction (p=0.039): the patients
treated by Gloreha showed a significant reduction (-10.65 mm; min: -49.14 mm; max: +27.84 mm) while the
patients treated in a conventional way showed an increment (+4.83 mm; min: -21.37 mm; max: +31.02 mm).
10
4.83
5
0
Gloreha Group
Control Group
delta hemiplegic hand volume
-5
-10
-10.65
-15
Vanoglio et al., 2013. All the patients, treated with Gloreha or by a therapist, decreased the level of oedema.
The clinical trial involved post-stroke patients in the sub-acute phase: they were treated 40 minutes for 30
days.
Molteni at al., 2011. After the treatment with the prototype of Gloreha 5 out of 7 post-stroke patients with
oedema showed a reduction of their symptoms.
14
 Gloreha can improve vascular pulsatility of flexors of paretic upper limb on
post-stroke patients.
Bissolotti et al., 2015. 7 post-stroke patients (up to a maximum of 6 months after the event) were recruited.
They were treated with Gloreha for 3 weeks (30 minutes per day, 3 sessions per week). The outcome
measures were hemoglobin (THb) profiles and tissue oxygenation index (TOI) in the muscle tissue evaluated
through Near-infrared spectroscopy (NIRS, NIMO system, Nirox Optoelectronics). Significant improvements
were found in THb (p=0.033). Gloreha induced significant changes in local muscle blood flow and oxygen
supply, contributing to decrease the subject reported symptoms of heaviness and stiffness in patients with
post-stroke hemiparesis.
Bissolotti et al., 2014. The clinical trial was carried out on 11 chronic patients after stroke (onset-admission
interval: 96.3±125.1 months). The treatment session with Gloreha lasted for 20 minutes. The researchers,
thanks to Near Infrared Spectroscopy (NIRS), assessed clinical benefits of Gloreha in terms of improvement in
local blood stream, improvement in capillary elasticity and improvement in proliferation of capillary and
cellular density around the fibres. In particular significant THb changes were assessed (THb is the total
hemoglobin index). The sum of THB pick changes was 19.32±8.20 (5.21±1.78% compared with basal value).
15
 Gloreha can decrease patients’ perception of heaviness, stiffness and pain
on upper limb.
Bissolotti et al., 2014. The clinical trial was carried out on 11 chronic patients after stroke (onset-admission
interval: 96.3±125.1 months). The treatment with Gloreha consisted of 10 daily sessions; the duration of each
session was 30 minutes. The researchers assessed significant clinical benefits in terms of patients’ perception.
The chart below shows the results collected at T0 (before the first treatment session with Gloreha), T1 (after
the first treatment session with Gloreha), T2 (before the last treatment session with Gloreha), T3 (after the
last treatment session with Gloreha). Wrist-fingers heaviness perception passed from 34.5±31.2 at T0 to
19.5±19.2 at T1; wrist-fingers stiffness perception passed from 43.6±23.7 to 25.5±19.6.
Variation of wrist-fingers heaviness perception
Variation of wrist-fingers stiffness perception
Variation of wrist-fingers pain perception
16
Rodigari et al., 2014. The clinical trial is involving hemiparetic patients after neuro-oncological surgery. The
treatment with Gloreha consists of 20 sessions; the duration of each session is 60 minutes. The chart below
shows the preliminary results related to 12 patients: pain is assessed through VAS Scale. VAS average was
1.33 (range: 0-3) at the beginning of treatment; it is 0.66 (range: 0-4) after the treatment (p=0.219). The trial
is still in progress and also a control group will be enrolled to confirm the preliminary findings.
1.4
1.33
1.2
1
0.8
0.66
0.6
0.4
0.2
0
T0 (VAS - average)
T1 (VAS - average)
17
 Gloreha can improve visuospatial exploration and attention in post-stroke
patients with hemispatial neglect.
Varalta et al., 2014. Three right-handed patients with right-hemisphere brain damage due to first-ever
ischemic stroke were recruited and treated with Gloreha. Each patient underwent a training program
consisting of 10 sessions; the duration of each session was 30 minutes. Gloreha was used to perform a robotassisted left (contralesional) hand training. During the first week of treatment, the subjects had to watch the
monitor in front of them and name the fingers being moved throughout the training session, while during the
second week of treatment they had to name the moving fingers with their eyes closed.
Line Crossing test is a visual search task that examines the patient’s ability to locate and cancel target stimuli
in the neglected hemispace. All patients showed improved performance (6.7%, 89.5% and 80% increase in
lines crossed) with two patients reaching normal performance levels.
18
18
18
16
14
14
12
Line Crossing test (left)
12
10
10
Before the treatment
8
6
After the treatment
6
4
2
0
Patient A
Patient B
Patient C
The Bells test allows for a qualitative and quantitative assessment of hemispatial neglect in the near extrapersonal space. One patient improved performance (50% increase), while one patient showed no change and
one patient declined (-10.3% change).
35
30
30
29
26
25
20
21
21
20
Bells test
Before the treatment
15
After the treatment
10
5
0
Patient A
Patient B
Patient C
The Sentence Reading test examines the ability to read sentences written from left to right. All patients
showed improved performance (800%, 57.1% and 42,9% increase in number of sentences read).
18
12
11
10
10
8
7
8
7
Sentence Reading test
6
Before the treatment
4
After the treatment
2
0
0
Patient A
Patient B
Patient C
The Saccadic Training - subtest of the RehaCom® software - was used to evaluate the reaction time for right
and left stimuli. All patients showed improved performance (-62.8%, -15.5% and -9.7% change of the left
hemifield reaction time).
8000
7252
7000
5726
6000
5169
5000
Saccadic training (left)
Before the treatment
4000
2698
3000
2411
After the treatment
2038
2000
1000
0
Patient A
Patient B
Patient C
The Sustained Attention to Response Task is a reaction time task for sustained attention and cognitive control
that evaluates the ability to sustain attention with a response-suppression element. All patients showed
improved performance (-20.5%, -5.8% and -10% change of the reaction time) with two patients reducing also
incorrect responses (-42.9% and -73.3%) and one patient increasing them (9.1%).
700
600
500
612
551
511
406
452
426
Sustained Attention to Response Task
400
Before the treatment
300
After the treatment
200
100
0
Patient A
Patient B
Patient C
19
 Gloreha is well tolerated by patients: all the tests show a high compliance
level.
 Gloreha can increase the time of treatment, at a limited cost: Gloreha can
bring a significant advantage in economic terms and enable the reallocation of
human resources (i.e. therapists).
Vanoglio et al., 2013. The cost of traditional treatment, performed by therapist, was higher than the cost of
Gloreha treatment (the time necessary for the therapist to use the device was considered; the cost of the
device was not considered). The treatment was composed of 30 rehabilitation sessions (40 minutes per
session).
400
€ 336.00
350
300
250
Group treated with
Gloreha
200
150
€ 100.52
Control group
100
50
0
Cost per patient
New clinical trials are in progress to substantiate and expand the results mentioned
above, using a bigger sample size and also testing Gloreha on patients with further
diseases as spinal cord injury.
Specific studies are going on to:
 measure the phenomena of brain plasticity promoted by Gloreha, thanks to a
fMRI (Functional Magnetic Resonance Imaging) and quantitative analysis of
EEG;
 measure the clinical benefits of a combined application Gloreha rehabilitation
glove + Gloreha DAS (Dynamic Arm Support);
 measure the clinical benefits of the home treatment performed with Gloreha
Lite (multicenter clinical trial).
20
Gloreha was developed in accordance with the conclusions of the most recent
scientific literature:
 a rehabilitation treatment after stroke has to be intensive, repetitive,
functional, task-oriented, specific, customizable20,21;
 biomechatronic devices, robotic systems and computer interfaces can be
useful for facilitating functional recovery and reducing motor impairment of
upper limb22,23,24,25;
 a repetitive training program based on flexion and extension of the fingers
can improve the function of plegic hand after stroke: it can reduce the
oedema, maintain or increase the range of motion and muscle lengths,
prevent spasticity26,27,28,29,30;
 passive stretch can prevent connective tissue accumulation in muscle31 and
help motor learning32,33,34;
20
Kollen BJ, Lindeman E. Understanding the pattern of functional recovery after stroke: Facts and theories. Restorative
Neurology and Neuroscience 2004;22:281–299
21
Van Peppen RP, Kwakkel G, Wood-Dauphinee S, Hendriks HJ, Van der Wees PJ, Dekker J. The impact of physical
therapy on functional outcomes after stroke: what’s the evidence? Clin Rehabil 2004;18:833–62.
22
Masiero S, Celia A, Rosati G, Armeni M. Robotic-assisted rehabilitation of the upper limb after acute stroke. Arch
Phys Med Rehabil 2007;88:142-9.
23
Kiguchi K, Iwami K, Yasuda M, Watanabe K, Fukuda T. An exoscheleton robot for human shoulder joint motion assis.
IEEE/ASME Trans Mech 2003;8:126-36.
24
Hesse S, Schulte-Tigges G, Konrad M, Bardeleben A, Werner C. Robot-assisted arm trainer for the passive and active
practice of bilateral forearm and wrist movement in hemiparetic subjects. Arch Phys Med Rehab 2003;84:915-20.
25
Volpe B, Krebs H, Hogan N, Edelsteim L, Diels C, Aisen M. A novel approach to stroke rehabilitation: Robot aided
sensorimotor stimulation. Neurology 1999;54:1938-44.
26
Carey JR, Kimberley TJ, Lewis SM, et al. Analysis of fMRI and finger tracking training in subjects with chronic stroke.
Brain 2002;125(pt 4):773-88.
27
Carey JR, Durfee WK, Bhatt E, et al. Comparison of finger tracking versus simple movement training via
telerehabilitation to alter hand function and cortical reorganization after stroke. Neurorehabil Neural Repair
2007;21:216-32.
28
Giudice M.L. Effects of Continuos Passive Motion and elevation on hand edema. The American Journal of
Occupational Theraphy, 1990; Oct; 44(10):914-21
29
Dirette D., Hinojosa J. Effects of continuos passive motion on the edematous hands of two persons with flaccid
hemiplegia. The American Journal of Occupational Theraphy, 1994; May; 48(5):403-409.
30
Xu X.L., Tong R.K., Song R., Zheng X.J., Leung W. W. A comparison between electromyography-driven robot and
passive motion device on wrist rehabilitation for chronic stroke. Neurorehabiltation and neural repair, 2009; Jun 16
31
Williams P E, Catanese T, Lucey E G, Goldspink G: The importance of stretch and contractile activity in the prevention
of connective tissue accunulation in muscle. J Anat 1988; 158: 109-114.
32
Seitz et al. A common frame work for perceptual learning. Curr. Neurobiol 2007, 17:1-6.
33
Winter et al. Hands-on theraphy intervention for upper limb motor dysfunction following stroke. Cochrane Database
Syst Rev 2011 Jun 15; 6:CD006609.
21
 the exercises with devices works on plastic processes in the central nervous
system thanks to neuromotor, visual and audio feedback: multi-sensory
action-observation systems enable patients to re-learn impaired motor
functions
through
the
activation
of
internal
action-related
35,36
representations ;
 motor imagery, passive movement, movement observation, hand exercises in
VR (Virtual Reality) can activate sensorimotor areas of the brain37,38,39,40,41.
Gloreha can be used in accordance with the most advanced rehabilitation
treatments: Motor Imagery, Mirror Therapy, Constraint-induced Therapy, Bimanual
Training.
34
Hwang CH, Seong JW, Son DS. Individual finger synchronized robot-assisted hand rehabilitation in subacute to
chronic stroke: a prospective randomized clinical trial of efficacy. Clinical Rehabilitation 2012;26(8); 696–704.
35
Lee MM, Cho HY, Song CH. The mirror therapy program enhances upper-limb motor recovery and motor function in
acute stroke patients. Am J Phys Med Rehabil 2012;91(8):689-96
36
Sale P, Franceschini M. Action observation and mirror neuron network: a tool for motor stroke rehabilitation. Eur J
Phys Rehabil Med. 2012 Jun;48(2):313-8. Epub 2012 Apr 20.
37
Szameitat AJ, Shen S, Conforto A, Sterr A. Cortical activation during executed, imagined, observed, and passive wrist
movements in healthy volunteers and stroke patients. Neuroimage. 2012 Aug 1;62(1):266-80. doi:
10.1016/j.neuroimage.2012.05.009. Epub 2012 May 11
38
August K, Lewis JA, Chandar G, Merians A, Biswal B, Adamovich S. FMRI analysis of neural mechanisms underlying
rehabilitation in virtual reality: activating secondary motor areas. Conf Proc IEEE Eng Med Biol Soc. 2006;1:3692-5.
39
Tunik E, Saleh S, Adamovich SV. Visuomotor discordance during visually-guided hand movement in virtual reality
modulates sensorimotor cortical activity in healthy and hemiparetic subjects. IEEE Trans Neural Syst Rehabil Eng. 2013
Mar;21(2):198-207. doi: 10.1109/TNSRE.2013.2238250. Epub 2013 Jan 9.
40
Saleh S, Bagce H, Qiu Q, Fluet G, Merians A, Adamovich S, Tunik E. Mechanisms of neural reorganization in chronic
stroke subjects after virtual reality training. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:8118-21. doi:
10.1109/IEMBS.2011.6092002.
41
Tunik E, Adamovich SV. Remapping in the ipsilesional motor cortex after VR-based training: a pilot fMRI study. Conf
Proc IEEE Eng Med Biol Soc. 2009;2009:1139-42. doi: 10.1109/IEMBS.2009.5335392.
22