Is Robot-Assisted Therapy Effective for the Upper Extremity Following a Stroke

Study Overview
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Brief Summary
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The aim of this study was to investigate the effects on upper-limb motor function of the addition of robotic rehabilitation (RR) and conventional rehabilitation (CR) treatments to intensive trunk rehabilitation (ITR). A total of 41 subacute stroke patients were randomly allocated to two groups: RR and CR. Both groups received the same ITR procedure (6x5x60 weeks/days/minutes). Following ITR, a robot-assisted rehabilitation program of 60 minutes, five days a week, for six weeks, was applied to the RR group, and an individualized upper extremity rehabilitation program to the CR group. Evaluations were made at baseline and after six weeks using the Trunk Impairment Scale (TIS), Fugl-Meyer Upper Extremity Motor Evaluation Scale (FMA-UE), and Wolf Motor Function Test (WMFT).

Detailed Description
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Assessments: - Demographic Data Form: The researchers created a form to include the information on age, gender, stroke onset date, lesion type, affected side, and dominant extremity. - Fugl-Meyer Upper Extremity Assessment: This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients (18). It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. The affected upper extremities are assessed with the subject in a seated position. - Wolf Motor Function Test: This test was created to evaluate the motor ability of the upper extremity (19). The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The total score is used for the functional ability of the patients. The two items of muscle strength evaluation were not used in this study. - Trunk Impairment Scale: This scale evaluates static and dynamic sitting balance and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. The test-retest and inter-rater reliability coefficients of the scale have been shown to be 0.85-0.99 (21).

Official Title
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Is Robot-Assisted System Effective for the Maximization of Upper Extremity Motor Recovery in Intensive Body Rehabilitation Following a Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Robot-Assissted Therapy
* Procedure: Conventional Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40-85 years and having had a stroke in the last six months, Mini-Mental State Assessment score >20, Able to sit safely, No neglect issue, Fugl-Meyer Upper Extremity Assessment score <58. Exclusion Criteria: Modified Ashworth Scale >2, Severe reduction in visual acuity, Participation in another rehabilitation program, Subluxation or pain in the shoulder region.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A Randomized Controlled (One group received Robotic Rehabilitation, other group received conventional rehabilitation)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic Rehabilitation Group<br>The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward, and push-ups with a Swiss Ball. This group received a robotic rehabilitation program for the upper extremity with a Houston Bionics ExoRehab X brand/model device. This device has no motor force of repulsion or attraction. Patients initiate and maintain their movements during the exercise. The device supports the patient's active movement and allows extensive movement repetition. Before starting robotic rehabilitation, the patient was seated upright on the platform. The games were projected onto a 43-inch television screen. The exercise program was planned to include upper extremity movements in all directions. | Device: Robot-Assissted Therapy<br>* Houston Bionics ExoRehab X brand/model device was used for improving the upper extremity in subacute stroke.<br>|
| Active Comparator: Conventional Rehabilitation Group<br>The standardized ITR program was applied to both groups for 60 minutes a day, five days a week, for six weeks. During this period, lower extremity rehabilitation was added if needed in addition to trunk rehabilitation. Exercises for the lower extremities were applied according to the patient's individual needs. The ITR program included exercises of abdominal strengthening, controlled pelvic movements, bridging, trunk lateral flexion and rotation, reaching forward and sideways, and push-ups with a Swiss Ball. CR applied after the ITR program consisted of an individualized rehabilitation program for the upper extremities. These rehabilitation programs generally included activities for functional purposes (dressing, object manipulation, reaching, cup holding, range of motion, strengthening, weight-bearing, etc.). The treatment program was applied five days a week for six weeks, with the session duration limited to 60 minutes. | Procedure: Conventional Rehabilitation<br>* It is an upper extremity rehabilitation program prepared in line with individual needs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Extremity Assessment: | This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. | At the baseline | 
| Fugl-Meyer Upper Extremity Assessment: | This disease-specific scale was created as an objective motor impairment scale to assess recovery in post-stroke hemiplegic patients. It includes subsections that assess joint movements, coordination, and reflex activities related to the shoulder, elbow, forearm, wrist, and hand. The maximum score that can be obtained is 66, with a high score indicating good motor condition. | At the end of the 6th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic Data Form | Demographic Characteristics | At the baseline | 
| - Wolf Motor Function Test: | This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability. | At the baseline | 
| - Wolf Motor Function Test: | This test was created to evaluate the motor ability of the upper extremity. The test consists of 17 items, 15 of which are related to the fields of functional skill and performance time, and 2 to muscle strength (20). The two items of muscle strength evaluation were not used in this study. A high score indicates fine motor ability. | At the end of the 6th week | 
| Trunk Impairment Scale | This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. | At the baseline | 
| Trunk Impairment Scale | This scale evaluates static and dynamic sitting balance, and trunk coordination with seventeen items. The total score ranges from 0 - 23 points, with a higher score indicating better performance. | At the end of the 6th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic Rehabilitation, Conventional Rehabilitation, Intensıve Trunk Rehabilitation, Motor Function