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Completed

NCT Number: NCT06933147

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constraint-Induced Movement Therapy (CIMT)

Behavioral

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)

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 18, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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