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

NCT07164612 | Not Yet Recruiting

• 1 other identifier: MRC-01-25-298
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Occupations; Occupation-based intervention; Occupational Therapy; Motor Activity; Motor Skills; Patient Participation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment (FMA)

  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.

  At baseline, immediately post 4th weeks, and 6th week of the intervention.

Secondary Outcomes (4)

• Action Research Arm Test (ARAT)

  It will be conducted at baseline, immediately post 4th weeks, and 6th week of the intervention.

• Functional independence measure (FIM)

  At baseline, immediately post 4th weeks, and 6th week of the intervention.

• Stroke Impact Scale (SIS)

  At baseline, immediately post 4th weeks, and 6th week of the intervention.

• Canadian Occupational Performance Measure (COPM)

  At baseline, immediately post 4th weeks, and 6th week of the intervention.

Study Arms (2)

OBBT group

EXPERIMENTAL

Participants in the experimental group will receive face- to- face individual 30 minutes OBBT program in addition to conventional therapy. These 30 -minute OBBT session will be added to the standard conventional therapy sessions (90 minutes).

Other: Occupation-Based Bilateral Upper Limb Training (OBBT)

Conventional Therapy (control group)

OTHER

Participants in the control group will receive conventional therapy consisting of standard rehabilitation approaches for upper limb impairments.

Other: Conventional therapy group

Interventions

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.

OBBT group

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.

Conventional Therapy (control group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamad Medical Corporation: lead

Study Sites (1)

Hamad Medical Corporation\ Qatar Rehabilitation Institute

Doha, Qatar

Location

Related Publications (6)

• Dembele J, Triccas LT, Amanzonwe LER, Kossi O, Spooren A. Bilateral versus unilateral upper limb training in (sub)acute stroke: A systematic and meta-analysis. S Afr J Physiother. 2024 Jan 23;80(1):1985. doi: 10.4102/sajp.v80i1.1985. eCollection 2024.

  PMID: 38322652 BACKGROUND

• Kim SH, Park JH. The Effect of Occupation-Based Bilateral Upper Extremity Training in a Medical Setting for Stroke Patients: A Single-Blinded, Pilot Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2019 Dec;28(12):104335. doi: 10.1016/j.jstrokecerebrovasdis.2019.104335. Epub 2019 Sep 30.

  PMID: 31582271 BACKGROUND

• Meng G, Meng X, Tan Y, Yu J, Jin A, Zhao Y, Liu X. Short-term Efficacy of Hand-Arm Bimanual Intensive Training on Upper Arm Function in Acute Stroke Patients: A Randomized Controlled Trial. Front Neurol. 2018 Jan 19;8:726. doi: 10.3389/fneur.2017.00726. eCollection 2017.

  PMID: 29403422 BACKGROUND

• Renner CIE, Brendel C, Hummelsheim H. Bilateral Arm Training vs Unilateral Arm Training for Severely Affected Patients With Stroke: Exploratory Single-Blinded Randomized Controlled Trial. Arch Phys Med Rehabil. 2020 Jul;101(7):1120-1130. doi: 10.1016/j.apmr.2020.02.007. Epub 2020 Mar 4.

  PMID: 32145277 BACKGROUND

• Stoykov ME, Lewis GN, Corcos DM. Comparison of bilateral and unilateral training for upper extremity hemiparesis in stroke. Neurorehabil Neural Repair. 2009 Nov;23(9):945-53. doi: 10.1177/1545968309338190. Epub 2009 Jun 16.

  PMID: 19531608 BACKGROUND

• Summers JJ, Kagerer FA, Garry MI, Hiraga CY, Loftus A, Cauraugh JH. Bilateral and unilateral movement training on upper limb function in chronic stroke patients: A TMS study. J Neurol Sci. 2007 Jan 15;252(1):76-82. doi: 10.1016/j.jns.2006.10.011. Epub 2006 Nov 28.

  PMID: 17134723 BACKGROUND

MeSH Terms

Conditions

Stroke; Motor Activity; Patient Participation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Huda Abdelrahim Yousef, MSc.

CONTACT

+97450394388; HYousef2@hamad.qa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data Analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)