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NCT Number: NCT07164612

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

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Health Behavior Motor Activity Nervous System Diseases Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamad Medical Corporation\ Qatar Rehabilitation Institute

Doha, Qatar

Location contact

Huda Abdelrahim Yousef, Master degree

CONTACT

[email protected]

+97450394388

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Occupation-Based Bilateral Upper Limb Training (OBBT)

Other

Intervention sessions for experimental group will be conducted 5 times per week over 6 weeks. OBBT will be used to engage both upper limbs simultaneously in simulate real-life functional tasks which tailored to individual needs, focusing on improving the patient's ability to perform daily activities such as dressing, washing, and cooking. The training will emphasize occupation-specific repetitive practice for at least two selected occupations and encouraged active participation of both hands during functional tasks to improve use of both upper limb motor functions and activity participation. Additionally, it will seek to support stroke survivors in their pursuit of an independent, productive, and functional recover.

Conventional therapy group

Other

Conventional therapy includes passive and active range of motion exercises, strengthening exercises, basic functional activities and mobility training, and activities designed to improve muscle tone and mobility in the affected upper limb among stroke survivors. The conventional therapy sessions will be delivered 5 times per week for 90 minutes over 6 weeks. Therapy sessions will be individualized to the participant's needs and will be provided by senior occupational therapists.

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: 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 outcomes

  1. Action Research Arm Test (ARAT)

    Time frame: 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.

  2. Functional independence measure (FIM)

    Time frame: 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.

  3. Stroke Impact Scale (SIS)

    Time frame: 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.

  4. Canadian Occupational Performance Measure (COPM)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huda Abdelrahim Yousef, MSc.

CONTACT

[email protected]

+97450394388

Sponsors and collaborators

Lead sponsor

Hamad Medical Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 10, 2025
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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