ClinicalTrials.gg
Not yet recruitingNCT07164612Updated Sep 22, 2025

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

An interventional study of Occupation-Based Bilateral Upper Limb Training (OBBT) and Conventional therapy group in Stroke, sponsored by Hamad Medical Corporation. Not yet recruiting at 1 site in Qatar. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Stroke

Keywords

  • Stroke
  • Occupations
  • Occupation-based intervention
  • Occupational Therapy
  • Motor Activity
  • Motor Skills
  • Patient Participation
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 150 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Hamad Medical Corporation is the lead sponsor of 139 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ( ≥ 22)
  5. With arm and hand upper extremity Brunnstrom stage of >3
  6. Free of any other neurological diseases.

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    OBBT group

    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)

  • Other
    Conventional Therapy (control group)

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

    Other: Conventional therapy group

Interventions

  • OtherOccupation-Based Bilateral Upper Limb Training (OBBT)

    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.

  • OtherConventional therapy group

    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.

06

What researchers measure

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.

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

Secondary outcomes

  1. Action Research Arm Test (ARAT)

    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.

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

  2. Functional independence measure (FIM)

    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.

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

  3. Stroke Impact Scale (SIS)

    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.

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

  4. Canadian Occupational Performance Measure (COPM)

    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.

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

07

Study locations

1 site
  • Hamad Medical Corporation\ Qatar Rehabilitation Institute
    Doha, Qatar
    • Huda Abdelrahim Yousef, Master degree · ContactHYousef2@hamad.qa · +97450394388
08

References and documents

Publications

  • 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. PubMed 38322652 ↗
  • 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. PubMed 31582271 ↗
  • 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. PubMed 29403422 ↗
  • 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. PubMed 32145277 ↗
  • 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. PubMed 19531608 ↗
  • 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. PubMed 17134723 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07164612
Responsible party
Sponsor
First posted
Sep 10, 2025
Start date
Sep 2025 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 22, 2025

Study contacts

Huda Abdelrahim Yousef, MSc.
Contact
HYousef2@hamad.qa
+97450394388

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion