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NCT Number: NCT07626554

CIMT Versus HABIT in Late Sub-Acute Post-Stroke Rehabilitation

This study will compare the effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training on upper extremity function in late sub-acute post-stroke patients. It will be a randomized controlled trial. Eligible participants will be randomly allocated into two groups. One group will receive Constraint Induced Movement Therapy, while the other group will receive Hand-Arm Bimanual Intensive Training. Both groups will also receive standard physiotherapy for mobility and postural control. The intervention will continue for 3 weeks. Outcomes will be assessed at baseline and after the intervention using upper limb function and motor control assessment tools.

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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 and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah College of Rehabilitation Sciences

Lahore, Punjab Province, 55100, Pakistan

About this study

Stroke commonly affects upper extremity function and may reduce a patient's ability to perform daily activities independently. In the late sub-acute phase after stroke, structured rehabilitation may help improve arm and hand function, motor control, and real-world use of the affected upper limb. Constraint Induced Movement Therapy encourages use of the affected upper limb by restricting the unaffected arm and providing intensive task-oriented training. Hand-Arm Bimanual Intensive Training focuses on coordinated use of both hands through functional bimanual tasks. This study will compare these two rehabilitation approaches in late sub-acute post-stroke patients. Findings may help guide evidence-based selection of upper limb rehabilitation strategies for improving functional recovery after stroke.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Adults aged 40 years and above.

  • Diagnosed with unilateral ischemic or hemorrhagic stroke.
  • Stroke duration between 3 to 6 months.
  • Mini-Mental State Examination score of 24 or above.
  • Able and willing to provide informed consent.

Exclusion criteria

Severe pain in the more affected upper limb on verbal rating scale.

  • Spasticity greater than 3 on the Modified Ashworth Scale in the affected upper limb.
  • Unstable cardiovascular conditions.
  • Any traumatic musculoskeletal injury of the upper limb.

Treatment and study plan

Constraint Induced Movement Therapy

Behavioral

Constraint Induced Movement Therapy will be provided for 3 weeks. The unaffected upper limb will be constrained with a mitt for 90% of waking hours. Participants will receive intensive task-oriented training of the affected upper limb for 2 hours per day, 5 days per week. Activities will include reaching, grasping, manipulating objects, dressing, and eating tasks. Standard physiotherapy for mobility and postural control will also be provided.

Other names: CIMT

Hand-Arm Bimanual Intensive Training

Behavioral

Hand-Arm Bimanual Intensive Training will be provided for 3 weeks. Participants will receive supervised bimanual upper limb training for 2 hours per day, 5 days per week. Activities will include symmetrical and asymmetrical bilateral tasks such as folding clothes, pouring water, object transfer, and coordinated hand use. Standard physiotherapy for mobility and postural control will also be provided.

Primary outcomes

  1. Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

    Time frame: Baseline and Week 3 (Post-intervention)

    Measures motor recovery and voluntary movement of the affected upper limb after stroke.

  2. Action Research Arm Test (ARAT)

    Time frame: Baseline and Week 3 (Post-intervention)

    Assesses upper extremity functional ability including grasp, grip, pinch, and gross movement.

Secondary outcomes

  1. Motor Activity Log (MAL)

    Time frame: Baseline and Week 3

    Evaluates real-world use of the affected arm including Amount of Use and Quality of Movement.

  2. Box and Block Test (BBT)

    Time frame: Baseline and Week 3

    Assesses gross manual dexterity by counting blocks transferred within 60 seconds.

  3. Jebsen-Taylor Hand Function Test (JTHFT)

    Time frame: Baseline and Week 3

    Measures functional hand performance during simulated daily activities.

  4. Adult Assisting Hand Assessment (Ad-AHA)

    Time frame: Baseline and Week 3

    Measures effectiveness of affected hand use during bimanual task performance.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training for Upper Extremity Function in Late Sub-Acute Post-Stroke Patients

Acronym: CIMT-HABIT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 4, 2026
Registry last updated
Jun 4, 2026

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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