- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06933147
Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
April 10, 2025 updated by: Hafiza Zoha Musharaf, University of Lahore
Comparative Effects of Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
This study explored two common rehabilitation strategies-Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT)-to help stroke survivors improve movement and function in their weaker arm.
Stroke can often lead to reduced mobility in one arm, which affects a person's independence and quality of life.
This randomized clinical trial involved 64 patients between the ages of 40 to 60 who had experienced a stroke and were in the sub-acute phase of recovery.
Participants were randomly assigned to one of two groups: one group received CIMT and the other received RT.
The CIMT group had their unaffected arm restrained for 6 hours per day and completed 3 hours of supervised exercises using the affected arm.
The RT group participated in structured strength training using weights to target shoulder, elbow, and wrist muscles.
Both groups were treated five days a week for 12 weeks.
Throughout the study, researchers assessed participants using three tools: the Action Research Arm Test (ARAT) for arm function, the Fugl-Meyer Assessment (FMA) for motor recovery, and the Stroke-Specific Quality of Life Scale (SS-QOL) for overall well-being.
These assessments were conducted at baseline, week 4, week 8, and week 12.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial was designed to evaluate and compare the effects of two rehabilitation techniques-Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT)-on motor recovery and quality of life in patients recovering from sub-acute stroke.
Stroke survivors commonly experience upper limb impairments that hinder their ability to perform activities of daily living (ADLs).
Traditional therapy approaches often focus on general mobility, but targeted interventions like CIMT and RT have shown promise in enhancing specific motor functions and promoting neuroplasticity.
A total of 64 stroke patients, aged 40-60 years, who had mild to moderate upper limb impairment were included.
They were randomly assigned into two equal groups.
Group A received CIMT, which involved constraining the unaffected arm for 6 hours daily and performing 3 hours of functional task-oriented training with the affected limb.
Group B underwent RT, a progressive strengthening protocol that included concentric contractions of the shoulder, elbow, and wrist using weighted cuffs adjusted according to each patient's one-repetition maximum (1RM).
Both groups received standard physiotherapy and were given home exercise programs.
Patients were assessed using the Action Research Arm Test (ARAT), Fugl-Meyer Assessment (FMA), and Stroke-Specific Quality of Life Scale (SS-QOL) at four intervals: baseline, 4th week, 8th week, and 12th week.
Data were analyzed using SPSS version 24.
The study was ethically approved, and informed consent was obtained from all participants.
It adhered to the ethical guidelines of the University of Lahore.
Patients were assured of confidentiality, voluntary participation, and the right to withdraw at any point.
No adverse effects were reported from either intervention.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Lahore, Pakistan, 54590
- The University of Lahore Teaching Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient having age between 40-60 years
- Both gender were included
- Patient diagnosed with hemiparesis having grade 1 or 2 using Modified Ashworth Scale (MAS)
- Participant able to sit independently for 60 min
- Patients experiencing functional limitations in upper limb motor function
Exclusion Criteria:
- Participants with severe aphasia, severe shoulder pain affecting therapy or any comorbid condition that could limit UE function, visual or hearing impairment
- Uncontrolled pain or spasticity in the affected arm
- History of shoulder instability or major orthopedic surgery in the affected arm
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Constraint-Induced Movement Therapy (CIMT) Group
Participants in this group received Constraint-Induced Movement Therapy (CIMT) for 12 weeks.
The unaffected upper limb was constrained for 6 hours per day using a mitt, and patients completed 3-hour daily sessions of task-specific functional training with the affected limb, 5 days per week.
Exercises included grasping, stretching, pushing, button pressing, and fine motor tasks designed to improve upper limb function and daily activity performance.
A home exercise plan was also provided.
|
This intervention involved constraining the unaffected upper limb for 6 hours per day and performing 3-hour intermittent daily sessions of functional task practice with the affected limb for 12 weeks, 5 days per week.
Exercises included stretching, grasping, dexterity tasks, and functional activities like self-feeding and button pressing.
The program used shaping techniques to increase task difficulty and improve motor recovery.
A home exercise program was also prescribed for daily practice.
|
|
Experimental: Resistance Training (RT) Group
Participants in this group underwent Resistance Training (RT) focused on the affected upper extremity for 12 weeks.
Exercises targeted shoulder, elbow, and wrist muscles using weight cuffs (½-1 kg) based on 1RM assessment.
Each session included 3 sets of 8 reps for 4 different exercises, 5 days a week.
The training started with 50% 1RM intensity for 4 weeks and progressed to 70% over the next 8 weeks.
Sessions lasted 60 minutes and included rest intervals.
A structured home exercise program was also provided.
|
This intervention consisted of structured progressive resistance exercises targeting the affected upper limb muscles (shoulder, elbow, wrist) using weight cuffs (½-1 kg).
Sessions were 60 minutes/day, 5 days/week, for 12 weeks.
Intensity progressed from 50% to 70% of 1-repetition maximum (1RM) based on individual capacity.
Exercises were performed in 3 sets of 8 repetitions for each muscle group, with 2-minute rest intervals.
A home program included additional wrist and hand strengthening tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Action Research Arm Test (ARAT)
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
The ARAT is a standardized test used to assess upper extremity motor function.
It evaluates grasp, grip, pinch, and gross arm movement using 19 items scored on a 4-point scale.
Scores range from 0 to 57, with higher scores indicating better function.
|
Baseline, Week 4, Week 8, and Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment (FMA) - Upper Extremity Section
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
The FMA is a widely used quantitative measure for assessing motor function, balance, and joint functioning in post-stroke patients.
The upper extremity section scores range from 0 to 66, with higher scores indicating improved motor recovery.
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Baseline, Week 4, Week 8, and Week 12
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Stroke-Specific Quality of Life Scale (SS-QOL)
Time Frame: Baseline, Week 4, Week 8, and Week 12
|
The SS-QOL is a validated self-reported questionnaire measuring the quality of life in stroke survivors across 12 domains.
It contains 49 items, scored on a 5-point Likert scale, with total scores ranging from 49 to 245 (higher scores indicate better quality of life).
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Baseline, Week 4, Week 8, and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lang CE, Strube MJ, Bland MD, Waddell KJ, Cherry-Allen KM, Nudo RJ, Dromerick AW, Birkenmeier RL. Dose response of task-specific upper limb training in people at least 6 months poststroke: A phase II, single-blind, randomized, controlled trial. Ann Neurol. 2016 Sep;80(3):342-54. doi: 10.1002/ana.24734. Epub 2016 Aug 16.
- Gracies JM, Pradines M, Ghedira M, Loche CM, Mardale V, Hennegrave C, Gault-Colas C, Audureau E, Hutin E, Baude M, Bayle N; Neurorestore Study Group. Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial. BMC Neurol. 2019 Mar 12;19(1):39. doi: 10.1186/s12883-019-1257-y.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 15, 2024
Primary Completion (Actual)
March 19, 2025
Study Completion (Actual)
April 2, 2025
Study Registration Dates
First Submitted
April 3, 2025
First Submitted That Met QC Criteria
April 10, 2025
First Posted (Actual)
April 18, 2025
Study Record Updates
Last Update Posted (Actual)
April 18, 2025
Last Update Submitted That Met QC Criteria
April 10, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rec-UOL-/502/08/24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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