NCT07626554

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
1mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Jun 2025Aug 2026

Study Start

First participant enrolled

June 5, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 6, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2026

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

1.1 years

First QC Date

June 1, 2026

Last Update Submit

June 1, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment - Upper Extremity (FMA-UE)

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

    Baseline and Week 3 (Post-intervention)

  • Action Research Arm Test (ARAT)

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

    Baseline and Week 3 (Post-intervention)

Secondary Outcomes (4)

  • Motor Activity Log (MAL)

    Baseline and Week 3

  • Box and Block Test (BBT)

    Baseline and Week 3

  • Jebsen-Taylor Hand Function Test (JTHFT)

    Baseline and Week 3

  • Adult Assisting Hand Assessment (Ad-AHA)

    Baseline and Week 3

Study Arms (2)

Constraint Induced Movement Therapy Group

EXPERIMENTAL

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

Behavioral: Constraint Induced Movement Therapy

Hand-Arm Bimanual Intensive Training Group

ACTIVE COMPARATOR

Participants in this arm will receive Hand-Arm Bimanual Intensive Training for 3 weeks. Training will be provided for 2 hours per day, 5 days per week, using symmetrical and asymmetrical bimanual activities such as folding clothes and pouring water. Participants will also receive standard physiotherapy for mobility and postural control.

Behavioral: Hand-Arm Bimanual Intensive Training

Interventions

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.

Also known as: CIMT
Constraint Induced Movement Therapy Group

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.

Hand-Arm Bimanual Intensive Training Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah College of Rehabilitation Sciences

Lahore, Punjab Province, 55100, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Ambreen I IQBAL

    Riphah International University Role

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will remain blinded to group allocation during baseline and post-intervention assessments.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: participants will be randomly allocated into two groups: Constraint Induced Movement Therapy group and Hand-Arm Bimanual Intensive Training group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

June 4, 2026

Study Start

June 5, 2025

Primary Completion (Estimated)

July 6, 2026

Study Completion (Estimated)

August 6, 2026

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared because no formal data-sharing mechanism or repository has been established for this academic study. Participant confidentiality and privacy will be maintained.

Locations