StrokeNCT07578792
Standard vs Dual-Task Hand-Arm Bimanual Training in Post-Stroke Patients
A study testing Standard HABIT and Dual-Task-Oriented HABIT in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study aims to compare the effects of standard and dual-task-oriented hand-arm bimanual intensive training on cognitive performance, upper limb function, and coordination in post-stroke patients. Stroke often leads to impairments in motor and cognitive functions, limiting independence in daily activities. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Standard HABIT and Dual-Task-Oriented HABIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 6 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both male and female' genders.
- Adults aged between 40 and 70 years.
- Clinically diagnosed ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI).
- Modified Ashworth Scale 1, 1+ and 2 will be included.
- Presence of mild to moderate upper limb motor impairment (as defined by Fugl Meyer Assessment score range 23-55 or clinical evaluation).
- Ability to comprehend and follow simple verbal instructions.
Who cannot join
- Severe cognitive impairment or expressive/receptive aphasia limiting effective communication. (10)
- Other neurological disorders (e.g., Parkinson's disease) or psychiatric illnesses that could confound results.(11)
- Exclusion of patients with prior upper limb impairments (e.g., arthritis) unrelated to the recent stroke event.(10)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Effects of Standard and Dual Task Oriented Hand Arm Bimanual Intensive Training on Cognitive Performance, Upper Limb Functions and Coordination Among Post-Stroke Patients
This study aims to compare the effects of standard and dual-task-oriented hand-arm bimanual intensive training on cognitive performance, upper limb function, and coordination in post-stroke patients. Stroke often leads to impairments in motor and cognitive functions, limiting independence in daily activities. This randomized controlled trial will include adult stroke patients who will be assigned to two groups: one receiving standard training and the other receiving dual-task-oriented training. The interventions will be provided over eight weeks. Outcomes will be assessed using standardized tools for motor function, coordination, and cognition. The study seeks to determine whether combining cognitive and motor tasks leads to better rehabilitation outcomes compared to standard therapy alone.
Read the detailed description
Stroke is a leading cause of long-term disability, commonly resulting in deficits in upper limb function, coordination, and cognitive performance. These impairments significantly affect the ability to perform daily activities and reduce overall quality of life. Rehabilitation strategies that integrate both motor and cognitive components may enhance functional recovery and promote neuroplasticity.
Hand-Arm Bimanual Intensive Training (HABIT) is a task-specific, repetitive, and goal-oriented intervention designed to improve bilateral upper limb function through coordinated use of both hands. While standard HABIT has demonstrated effectiveness in improving motor outcomes, dual-task-oriented HABIT incorporates simultaneous cognitive demands, such as attention and problem-solving, to better simulate real-life functional activities.
This study is a randomized controlled trial designed to compare the effects of standard HABIT and dual-task-oriented HABIT on cognitive performance, upper limb motor function, and coordination among post-stroke patients. A total of 20 participants aged 40-70 years with mild to moderate upper limb impairment will be recruited. Participants will be randomly assigned to either the intervention group receiving a combination of standard and dual-task-oriented HABIT or the control group receiving standard HABIT only. The intervention will be delivered over eight weeks, with three sessions per week.
Outcome measures will include the Fugl-Meyer Assessment for upper limb function, Action Research Arm Test for functional performance, Finger-to-Nose test for coordination, and Montreal Cognitive Assessment for cognitive evaluation. Assessments will be conducted at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
The findings of this study will provide evidence on whether integrating cognitive challenges into bimanual training leads to superior rehabilitation outcomes, supporting more comprehensive and functionally relevant stroke rehabilitation strategies.
- Conditions
- Stroke
- Being tested
- Standard HABIT, Dual-Task-Oriented HABIT
- Keywords
- Dual TO-HABIT,, Stroke, Bimanual activities, Coordination, Standard HABIT, Upper Extremity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard HABITBehavioural
Participants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week.
Dual-Task-Oriented HABITOther
Participants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week.
| Study group | Role | What they receive |
|---|---|---|
| Standard HABIT | Active comparator | Participants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week. Receives: Behavioral: Standard HABIT |
| Dual-Task-Oriented HABIT | Experimental | Participants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week. Receives: Other: Dual-Task-Oriented HABIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Motor Function
Upper limb motor function will be assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UL), a validated scale evaluating motor recovery, movement control, and coordination in post-stroke patients.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion6 Aug 2026 (estimated)
- Study completion6 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- participants will be assigned to one of two parallel groups: standard hand-arm bimanual intensive training or dual-task-oriented hand-arm bimanual intensive training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ambreen iqbal, phD, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578792
- Sponsor's protocol ID
- Muhammad Umar Butt
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. The data will be used solely for academic and research purposes and will remain confidential.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Standard and Dual Task Oriented Hand Arm Bimanual Intensive Training on Cognitive Performance, Upper Limb Functions and Coordination Among Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07578792
- Acronym / sponsor ID
- Muhammad Umar Butt
- Conditions
- Stroke
- Keywords
- Dual TO-HABIT,, Stroke, Bimanual activities, Coordination, Standard HABIT, Upper Extremity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 6 Aug 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effects of standard and dual-task-oriented hand-arm bimanual intensive training on cognitive performance, upper limb function, and coordination in post-stroke patients. Stroke often leads to impairments in motor and cognitive functions, limiting independence in daily activities. This randomized controlled trial will include adult stroke patients who will be assigned to two groups: one receiving standard training and the other receiving dual-task-oriented training. The interventions will be provided over eight weeks. Outcomes will be assessed using standardized tools for motor function, coordination, and cognition. The study seeks to determine whether combining cognitive and motor tasks leads to better rehabilitation outcomes compared to standard therapy alone.
Detailed description
Stroke is a leading cause of long-term disability, commonly resulting in deficits in upper limb function, coordination, and cognitive performance. These impairments significantly affect the ability to perform daily activities and reduce overall quality of life. Rehabilitation strategies that integrate both motor and cognitive components may enhance functional recovery and promote neuroplasticity.
Hand-Arm Bimanual Intensive Training (HABIT) is a task-specific, repetitive, and goal-oriented intervention designed to improve bilateral upper limb function through coordinated use of both hands. While standard HABIT has demonstrated effectiveness in improving motor outcomes, dual-task-oriented HABIT incorporates simultaneous cognitive demands, such as attention and problem-solving, to better simulate real-life functional activities.
This study is a randomized controlled trial designed to compare the effects of standard HABIT and dual-task-oriented HABIT on cognitive performance, upper limb motor function, and coordination among post-stroke patients. A total of 20 participants aged 40-70 years with mild to moderate upper limb impairment will be recruited. Participants will be randomly assigned to either the intervention group receiving a combination of standard and dual-task-oriented HABIT or the control group receiving standard HABIT only. The intervention will be delivered over eight weeks, with three sessions per week.
Outcome measures will include the Fugl-Meyer Assessment for upper limb function, Action Research Arm Test for functional performance, Finger-to-Nose test for coordination, and Montreal Cognitive Assessment for cognitive evaluation. Assessments will be conducted at baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
The findings of this study will provide evidence on whether integrating cognitive challenges into bimanual training leads to superior rehabilitation outcomes, supporting more comprehensive and functionally relevant stroke rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- participants will be assigned to one of two parallel groups: standard hand-arm bimanual intensive training or dual-task-oriented hand-arm bimanual intensive training.
| Arm | Type | Receives |
|---|---|---|
| Standard HABIT | Active comparator | Behavioral: Standard HABITParticipants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week. |
| Dual-Task-Oriented HABIT | Experimental | Other: Dual-Task-Oriented HABITParticipants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both male and female' genders.
Key exclusion criteria (3 listed)
- Severe cognitive impairment or expressive/receptive aphasia limiting effective communication. (10)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard HABITParticipants will receive standard hand-arm bimanual intensive training for 8 weeks, with three sessions per week. | Behavioural | Standard HABIT |
| Dual-Task-Oriented HABITParticipants will receive standard hand-arm bimanual intensive training for the first 4 weeks, followed by dual-task-oriented hand-arm bimanual intensive training for the remaining 4 weeks, with three sessions per week. | Other | Dual-Task-Oriented HABIT |
Primary outcome
Upper Limb Motor Function
Time frame: Baseline, Week 4, and Week 8
Upper limb motor function will be assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UL), a validated scale evaluating motor recovery, movement control, and coordination in post-stroke patients.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. The data will be used solely for academic and research purposes and will remain confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ambreen iqbal, phD study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard HABIT and Dual-Task-Oriented HABIT in people with Stroke, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ambreen iqbal, phD (+923227616154, iqbalambreen8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Motor Function (time frame: Baseline, Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 29 Oct 2026.