Trial Outcomes & Findings for Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation (NCT NCT02628418)
NCT ID: NCT02628418
Last Updated: 2016-09-15
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Results posted on
2016-09-15
Participant Flow
Participant milestones
| Measure |
Gloreha Group
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Gloreha Group
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
Baseline Characteristics
Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation
Baseline characteristics by cohort
| Measure |
Gloreha Group
n=15 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device
GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
SHR by Gloreha device: Each training session consisted of six parts:
1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
2. 7 min of a number sequence (counting from one to five);
3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
4. A sequence of wave-like finger movements (7 min)
5. A sequence of fist opening/closing (7 min)
6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=15 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation
2. Specific Hand Rehabilitation (SHR) performed by physiotherapist
General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72 years
STANDARD_DEVIATION 11 • n=5 Participants
|
73 years
STANDARD_DEVIATION 14 • n=7 Participants
|
72.5 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion. The specific hand interventionn consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.Outcome measures
| Measure |
Gloreha Group
n=15 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=15 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Number of Patients Who Completed the Hand Rehabilitation Program
|
14 participants
|
13 participants
|
PRIMARY outcome
Timeframe: Through study completion. The specific hand intervention consisted of a total of 30 sessions, lasting 40 min/day, for 5 days/week , from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.The feasibility of the device was assessed in terms of side effects (the physiotherapist was required to report any adverse events occurring during the study in regard to the use of Gloreha);
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Side Effects Using Gloreha Device
|
0 side effects
|
0 side effects
|
PRIMARY outcome
Timeframe: Baseline and end of the study after 30 sessions, an average of 6 weeksMotricity Index, a measure of the motor function of the paretic upper limb. Motricity Index used to measure the ability to activate a muscle group to move a body segment through a range of motion and resist external force. The upper extremity motricity index includes: 1. pinch grasp, 2. elbow flexion, and 3. shoulder abduction. The total upper extremity score involved adding one to the sum of the three actions. The score of each action ranges from 0 (no ability) to 33 (maximal ability) with a maximum possible score=100.
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation
|
23.0 units on a scale
Interval 13.6 to 32.4
|
5.2 units on a scale
Interval -0.4 to 10.7
|
PRIMARY outcome
Timeframe: Baseline and end of the study after 30 sessions, an average of 6 weeksNine Hole Peg Test (NHPT), a measure of coordination and mono-manual dexterity. It consists in collecting 9 pegs and inserting them into holes in a wooden base within a 50-sec time limit. The score is the average number of pegs inserted/tests performed.
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.
|
0.16 pegs/sec
Interval 0.09 to 0.25
|
0.02 pegs/sec
Interval -0.02 to 0.07
|
SECONDARY outcome
Timeframe: Baseline and end of the study after 30 sessions, an average of 6 weeksThe feasibility of the device was assessed in terms of the level of operator difficulty for the physiotherapist in managing the device, assessed by visual analogue scale (VAS) (0 extremely simple - 10 extremely difficult). This outcome was measured only in the Gloreha Group in which patients were treated with device.
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)
|
3.15 units on a scale
Standard Deviation 1.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of the study after 30 sessions, an average of 6 weeksThe Grip test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.
|
0.27 kg / (kg / m ^ 2)
Interval 0.13 to 0.41
|
0.03 kg / (kg / m ^ 2)
Interval -0.005 to 0.07
|
SECONDARY outcome
Timeframe: Baseline and end of the study after 30 sessions, an average of 6 weeksThe Pinch test is a measure of hand strength. Each patient, at baseline and at the end of the study, repeated the test 3 times and the mean value was normalized for body mass index (BMI).
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.
|
0.07 kg / (kg / m ^ 2
Interval 0.03 to 0.1
|
0.02 kg / (kg / m ^ 2
Interval -0.001 to 0.04
|
SECONDARY outcome
Timeframe: Baseline and end of the study after 30 sessions, an average of 6 weeksThe Arm disability was assessed of the study with the Quick version of the Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) questionnaire. The Quick-DASH is a 19-item ordinal scale with a 5-level rating of items from 1 (no difficulty) to 5 (unable to do). Quick-Dash can be divided into an 11-item (abilities and symptoms) and an 8-item optional work module and sports/performing arts module. In the 11-item sub-scale, the subject defines the ability to perform some actions (8 items) and the intensity of some symptoms (3 items), referring to the previous week. The total score range is from 19 (no disability) to 95 (full disability).
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.
|
-15.7 units on a scale
Interval -25.7 to 5.8
|
-0.43 units on a scale
Interval -4.5 to 3.6
|
SECONDARY outcome
Timeframe: Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.Costs were calculated in terms of the time required by healthcare personnel, using the average cost per hour of a physiotherapist per total number of rehabilitation treatments per patient. The equivalent cost of the device for the period of patient treatment was calculated incorporating depreciation, considering the estimated residual value of the device with depreciation rate of 20%.. Indirect costs were not considered because these were common to both groups.
Outcome measures
| Measure |
Gloreha Group
n=14 Participants
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR by Gloreha device: Each training session consisted of six parts:
1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=13 Participants
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.
SHR performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
The Costs Involved in Using Gloreha in the Rehabilitation
|
237 Euros/patient
|
480 Euros/patient
|
Adverse Events
Gloreha Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gloreha Group
n=15 participants at risk
The patients in the "Gloreha Group" underwent to following interventions:
1. General Rehabilitation (GR)
2. Specific Hand Rehabilitation (SHR) by Gloreha device
GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
SHR by Gloreha device: Each training session consisted of six parts:
1. A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
2. 7 min of a number sequence (counting from one to five);
3. A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
4. A sequence of wave-like finger movements (7 min)
5. A sequence of fist opening/closing (7 min)
6. A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min).
|
Control Group
n=15 participants at risk
The patients in the Control Group underwent to following interventions:
1. General Rehabilitation
2. Specific hand rehabilitation performed by physiotherapist
General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
Specific hand rehabilitation performed by physiotherapist: The activities were:
1. Flexion-extension of the fingers (10 min);
2. Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
3. Adduction and abduction of the fingers (10 min);
4. Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min).
|
|---|---|---|
|
Infections and infestations
Bacterial infection
|
0.00%
0/15 • Through study completion, from admission to discharge in the Rehabilitation Centers, over a period of about 6 weeks.
Three patients lost to follow-up for clinical problems not for side effects related to SHR. If Gloreha was able to open a spastic hand it would be potentially dangerous (the glove was not sensitized) so we cannot know exactly what happens on the patients' hand. If the force applied by Gloreha was such as to open a spastic hand it could cause pain.
|
13.3%
2/15 • Number of events 2 • Through study completion, from admission to discharge in the Rehabilitation Centers, over a period of about 6 weeks.
Three patients lost to follow-up for clinical problems not for side effects related to SHR. If Gloreha was able to open a spastic hand it would be potentially dangerous (the glove was not sensitized) so we cannot know exactly what happens on the patients' hand. If the force applied by Gloreha was such as to open a spastic hand it could cause pain.
|
|
Immune system disorders
Rheumaoid arthitis
|
6.7%
1/15 • Number of events 1 • Through study completion, from admission to discharge in the Rehabilitation Centers, over a period of about 6 weeks.
Three patients lost to follow-up for clinical problems not for side effects related to SHR. If Gloreha was able to open a spastic hand it would be potentially dangerous (the glove was not sensitized) so we cannot know exactly what happens on the patients' hand. If the force applied by Gloreha was such as to open a spastic hand it could cause pain.
|
0.00%
0/15 • Through study completion, from admission to discharge in the Rehabilitation Centers, over a period of about 6 weeks.
Three patients lost to follow-up for clinical problems not for side effects related to SHR. If Gloreha was able to open a spastic hand it would be potentially dangerous (the glove was not sensitized) so we cannot know exactly what happens on the patients' hand. If the force applied by Gloreha was such as to open a spastic hand it could cause pain.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place