The Effectiveness of Occupation-based Bilateral Arm Training on Motor Functions and Activity Participation Among Stroke Survivors During Inpatient Rehabilitation.

Not Applicable

Not yet recruiting

• Conditions: Stroke

• Registration Number: NCT07164612
• Lead Sponsor: Hamad Medical Corporation

Brief Summary

People with stroke often experience limitations in motor functions and activity participation. Occupation-based bilateral upper limb training (OBBT) using occupations as meaningful daily activities, and as part of the therapy. The activities in OBBT are tailored to the patient's life with the goal of boosting motivation and engagement to enhance activity performance and participation. This study is a randomized control trial that aims to explore the effect of OBBT along with the conventional therapy in comparison with the conventional therapy alone on motor functions and activity participation among stroke survivors in inpatient rehabilitation setting. This study will be conducted in Qatar Rehabilitation Institute, Hamad Medical Corporation, Doha, Qatar. Participants will be allocated randomly to either the OBBT group or the conventional therapy group. Participants in the OBBT group will receive 30 minutes OBBT program in addition to conventional therapy (90 minutes). Intervention sessions will be conducted 5 times per week over 6 weeks. The participants in the conventional therapy group will receive only the conventional therapy (90 minute). All participants will be assessed using the outcome measure immediately the day after completing the last intervention session at 4th week and 6th week.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Submitted: 2025-09-16
• Last Update Posted: 2025-09-22
• Primary Completion: 2027-04
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Diagnosed with first ischemic or hemorrhagic stroke by medical physician
2. Stroke onset ≤ 6 months
3. Both males and females with age 18-65 years
4. Cognitive functions within normal and mild deficit (MMSE ≥ 22)
5. With arm and hand upper extremity Brunnstrom stage of >3
6. Free of any other neurological diseases.

Exclusion Criteria

1. participants with previous stroke
2. musculoskeletal disease or sever pain affecting the upper extremities
3. participant who have taken part in another rehabilitative research
4. sever visual neglect or visual field deficit.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment (FMA)	At baseline, immediately post 4th weeks, and 6th week of the intervention.	More than 80% of studies use the Fugl-Meyer Assessment, making it the most popular outcome measure for evaluating upper limb motor function recovery after stroke. The assessment consists18 items for the shoulder, elbow, 5 items for the wrist, 7 items for the hand and fingers, and 3 items for upper extremity coordination. The total Fugl-Meyer Assessment (FMA) motor function score for the upper extremity is 66, with higher scores indicating greater motor performance.

Secondary Outcome Measures

Name	Time	Method
Action Research Arm Test (ARAT)	It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.	To examine the motor function for the paretic side. Action Research Arm Test consists 19 items distributed into 4 subscales of grasp, grip, pinch and gross movement. The total score on the Action Research Arm Test (ARAT) is 57, with higher scores indicating better motor performance.
Functional independence measure (FIM)	At baseline, immediately post 4th weeks, and 6th week of the intervention.	Functional Independent Measure (FIM) will be used to evaluate functional independence in activities such as self-care, sphincter control, transfer, locomotion, communication, and social cognition. It includes 18 items total, with a maximum score of 7 and a minimum score of 1, for a total score of 126. Higher score means more independent.
Stroke Impact Scale (SIS)	At baseline, immediately post 4th weeks, and 6th week of the intervention.	Stroke Impact Scale (SIS) will be used to detect the progress in stroke recovery. It includes 64 items into 8 parts including, strength, Activities of Daily Living, Instrumental Activities of Daily Living, mobility, hand function, memory and communication, emotion and participant. The Stroke Impact Scale (SIS) is a continuous measure ranging from 0 to 100, where 0 indicates no recovery and 100 indicates full recovery. Higher scores reflect greater perceived recovery.
Canadian Occupational Performance Measure (COPM)	At baseline, immediately post 4th weeks, and 6th week of the intervention.	Canadian Occupational Performance Measure (COPM) will be used to measure occupational performance ability. It includes a four stage, semi-constructive meeting session, participants will be asked to consider their goals, needs, and expectations for their daily lives. Performance and satisfaction with the chosen activity will then be measured on a 10 point scale with higher score means a greater performance and satisfaction.; In this study participant's choice of occupation-based activities and improvement in their performance and satisfaction, before and after the intervention, will be assessed using COPM.

Trial Locations

Locations (1)

Hamad Medical Corporation\ Qatar Rehabilitation Institute; 🇶🇦 Doha, Qatar