StrokeNCT06933147
Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
A study testing Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT) in people with Stroke, run by University of Lahore at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2024to 2 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Constraint-Induced Movement Therapy (CIMT), Resistance Training (RT)
- Keywords
- Action Research Arm Test, Constraint-Induced Movement Therapy, Fugl-Meyer Assessment, Quality of Life, Resistance Training, Stroke Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement Therapy (CIMT)Behavioural
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.
Resistance Training (RT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) Group | Experimental | 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. Receives: Behavioral: Constraint-Induced Movement Therapy (CIMT) |
| Resistance Training (RT) Group | Experimental | 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. Receives: Behavioral: Resistance Training (RT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Secondary outcomes (2)
Fugl-Meyer Assessment (FMA) - Upper Extremity Section
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.
Measured: Baseline, Week 4, Week 8, and Week 12
Stroke-Specific Quality of Life Scale (SS-QOL)
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).
Measured: Baseline, Week 4, Week 8, and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start15 Oct 2024
- Primary completion19 Mar 2025
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hafiza Zoha Musharaf, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933147
- Sponsor's protocol ID
- Rec-UOL-/502/08/24
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30871480Lang 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.
PubMed 27447365
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Resistance Training and Constrained Induced Movement Therapy on Upper Extremity Motor Recovery and Quality of Life in Sub-acute Stroke Patients
- ClinicalTrials.gov ID
- NCT06933147
- Acronym / sponsor ID
- Rec-UOL-/502/08/24
- Conditions
- Stroke
- Keywords
- Action Research Arm Test, Constraint-Induced Movement Therapy, Fugl-Meyer Assessment, Quality of Life, Resistance Training, Stroke Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 19 Mar 2025 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 18 Apr 2025 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) Group | Experimental | Behavioral: Constraint-Induced Movement Therapy (CIMT)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. |
| Resistance Training (RT) Group | Experimental | Behavioral: Resistance Training (RT)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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT)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. | Behavioural | Constraint-Induced Movement Therapy (CIMT) Group |
| Resistance Training (RT)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. | Behavioural | Resistance Training (RT) Group |
Primary outcome
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.
2 secondary outcomes
Fugl-Meyer Assessment (FMA) - Upper Extremity Section
Time frame: Baseline, Week 4, Week 8, and Week 12
Stroke-Specific Quality of Life Scale (SS-QOL)
Time frame: Baseline, Week 4, Week 8, and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Background: PubMed 30871480Gracies 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.
- Background: PubMed 27447365Lang 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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-Induced Movement Therapy (CIMT) and Resistance Training (RT) in people with Stroke, run by University of Lahore 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 5 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: finished, as of the sponsor's last update on 18 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Baseline, Week 4, Week 8, and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06933147, which also lists 2 linked publications.
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 18 Apr 2025.