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Feasibility and Efficacy of a Robotic Device for Hand Rehabilitation

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ClinicalTrials.gov Identifier: NCT02628418
Recruitment Status : Completed
First Posted : December 11, 2015
Results First Posted : August 3, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Palmira Bernocchi, Fondazione Salvatore Maugeri

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Stroke
Upper Extremity Hemiplegia
Disorder of Hand
Interventions Other: General Rehabilitation
Device: Specific hand rehabilitation by Gloreha device
Other: Specific hand rehabilitation performed by physiotherapist
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description

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).

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).
Period Title: Overall Study
Started 15 15
Completed 14 13
Not Completed 1 2
Reason Not Completed
Lost to Follow-up             1             2
Arm/Group Title Gloreha Group Control Group Total
Hide Arm/Group Description

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).

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 of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
72  (11) 73  (14) 72.5  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
8
  53.3%
8
  53.3%
16
  53.3%
Male
7
  46.7%
7
  46.7%
14
  46.7%
1.Primary Outcome
Title Number of Patients Who Completed the Hand Rehabilitation Program
Hide Description [Not Specified]
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 15 15
Measure Type: Number
Unit of Measure: participants
14 13
2.Primary Outcome
Title Side Effects Using Gloreha Device
Hide Description 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);
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

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 Number of Participants Analyzed 14 13
Measure Type: Number
Unit of Measure: side effects
0 0
3.Primary Outcome
Title Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Motricity Index at End of Inpatient Rehabilitation
Hide Description

Motricity 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.

Time Frame Baseline and end of the study after 30 sessions, an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

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).
Overall Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
23.0
(13.6 to 32.4)
5.2
(-0.4 to 10.7)
4.Primary Outcome
Title Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Nine Hole Peg Test at End of Inpatient Rehabilitation.
Hide Description Nine 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.
Time Frame Baseline and end of the study after 30 sessions, an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.

SHR on 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 Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: pegs/sec
0.16
(0.09 to 0.25)
0.02
(-0.02 to 0.07)
5.Secondary Outcome
Title The Feasibility of This New Neuromotor Rehabilitation Device (Gloreha)
Hide Description The 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.
Time Frame Baseline and end of the study after 30 sessions, an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group
Hide Arm/Group Description:

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).

Overall Number of Participants Analyzed 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.15  (1.0)
6.Secondary Outcome
Title Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Grip Test at End of Inpatient Rehabilitation.
Hide Description The 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).
Time Frame Baseline and end of the study after 30 sessions, an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific hand rehabilitation (SHR) performed by physiotherapist 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 Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: kg / (kg / m ^ 2)
0.27
(0.13 to 0.41)
0.03
(-0.005 to 0.07)
7.Secondary Outcome
Title Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Pinch Test at End of Inpatient Rehabilitation.
Hide Description The 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).
Time Frame Baseline and end of the study after 30 sessions, an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

TThe 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).

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific hand rehabilitation (SHR) performed by physiotherapist. 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 Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: kg / (kg / m ^ 2
0.07
(0.03 to 0.1)
0.02
(-0.001 to 0.04)
8.Secondary Outcome
Title Efficacy in Improving Arm Function Abilities Measured by the Change From Baseline in Quick-DASH Questionnaire at End of Inpatient Rehabilitation.
Hide Description

The 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).

Time Frame Baseline and end of the study after 30 sessions, an average of 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific hand rehabilitation (SHR) performed by physiotherapist. 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 Number of Participants Analyzed 14 13
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-15.7
(-25.7 to 5.8)
-0.43
(-4.5 to 3.6)
9.Secondary Outcome
Title The Costs Involved in Using Gloreha in the Rehabilitation
Hide Description 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.
Time Frame Through study completion, from admission to discharge in the Rehabilitation Centre, over a period of about 6 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description:

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).

The patients in the Control Group underwent to following interventions:

  1. General Rehabilitation (GR)
  2. Specific hand rehabilitation (SHR) performed by physiotherapist. 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 Number of Participants Analyzed 14 13
Measure Type: Number
Unit of Measure: Euros/patient
237 480
Time Frame Through study completion, from admission to discharge in the Rehabilitation Centers, over a period of about 6 weeks.
Adverse Event Reporting Description 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.
 
Arm/Group Title Gloreha Group Control Group
Hide Arm/Group Description

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).

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).
All-Cause Mortality
Gloreha Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gloreha Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/15 (6.67%)      2/15 (13.33%)    
Immune system disorders     
Rheumaoid arthitis  1/15 (6.67%)  1 0/15 (0.00%)  0
Infections and infestations     
Bacterial infection  0/15 (0.00%)  0 2/15 (13.33%)  2
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gloreha Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Palmira Bernocchi
Organization: Fondazione Salvatore Maugeri
Phone: 00390308253 ext 260
Responsible Party: Palmira Bernocchi, Fondazione Salvatore Maugeri
ClinicalTrials.gov Identifier: NCT02628418     History of Changes
Other Study ID Numbers: 1
First Submitted: December 3, 2015
First Posted: December 11, 2015
Results First Submitted: February 5, 2016
Results First Posted: August 3, 2016
Last Update Posted: September 15, 2016