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

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Device: Robot-Assissted Therapy; Procedure: Conventional Rehabilitation

• Registration Number: NCT05559385
• Lead Sponsor: Emresenocak

Brief Summary

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

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).

Study Timeline

• Study Start: 2022-01-02
• Primary Completion: 2022-06-17
• Study Completion: 2022-08-05
• Status Verified: 2022-09
• Study First Submitted: 2022-09-25
• Study First Submitted QC: 2022-09-28
• Study First Posted: 2022-09-29
• Last Update Submitted: 2022-09-29
• Last Update Posted: 2022-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Rehabilitation Group	Robot-Assissted Therapy	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.
Conventional Rehabilitation Group	Conventional Rehabilitation	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.

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper Extremity Assessment:	At the end of the 6th week	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.

Secondary Outcome Measures

Name	Time	Method
Trunk Impairment Scale	At the end of the 6th week	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.
Demographic Data Form	At the baseline	Demographic Characteristics
- Wolf Motor Function Test:	At the end of the 6th week	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.

Trial Locations

Locations (1)

Marmara University; 🇹🇷 Istanbul, Turkey