NCT07764939

Brief Summary

This controlled clinical study investigates and compares the effectiveness of CIMT and TOT in improving hand function among post-stroke patients. A total of 48 participants from hospitals in Sialkot will be randomly divided into two groups and receive a 3-week intervention consisting of 15 sessions. Outcomes will be assessed using the 9-Hole Peg Test, Jebsen-Taylor Hand Function Test, and grip strength, and the data will be analyzed using SPSS-21 under a single-blinded design.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jul 2025Aug 2026

Study Start

First participant enrolled

July 12, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2026

Expected
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

June 1, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Stroke rehabilitation, Constraint-Induced Movement Therapy, Task-Oriented Training, grip strength

Outcome Measures

Primary Outcomes (2)

  • Nine-Hole Peg Test (NHPT)

    The Nine-Hole Peg Test (9HPT) is a standardized and reliable assessment used to evaluate fine motor dexterity and hand function in individuals with post-stroke impairments. The test requires the participant to place nine pegs into nine holes and then remove them as quickly as possible, with each hand assessed separately. Performance is measured by the time (in seconds) required to complete the task, with shorter completion times indicating better manual dexterity and hand function, while longer times reflect greater impairment.

    Baseline to 3 weeks

  • Jebsen-Taylor Hand Function Test (JHFT)

    The Jebsen-Taylor Hand Function Test (JHFT) is a standardized assessment that takes approximately 15 to 45 minutes to administer and measures everyday fine and gross motor dexterity through seven timed tasks, such as writing, card turning, and object manipulation. Patients complete each task as quickly as possible with one hand at a time while the clinician records the completion time in seconds. Lower execution times indicate superior hand function, providing an efficient way to track pre- and post-treatment recovery or compare performance between limbs

    baseline to 3 weeks

Study Arms (2)

Constraint-Induced Movement Therapy Group

EXPERIMENTAL

Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) consisting of restraint of the unaffected upper limb combined with intensive task-specific training and repetitive functional exercises of the affected upper extremity for 3 weeks.

Behavioral: Constraint-Induced Movement Therapy

Task-Oriented Training Group

EXPERIMENTAL

Participants will receive task-specific upper limb rehabilitation involving functional activities, bilateral tasks, object manipulation, and daily living task practice for 45-60 minutes per session, 5 days per week for 3 weeks.

Behavioral: Task-Oriented Training

Interventions

Participants will undergo intensive upper limb rehabilitation involving shaping techniques, repetitive task practice, and restraint of the unaffected upper limb for 90% of waking hours, 5 days per week for 3 weeks. The therapy is delivered for 3 weeks (15 sessions; 5 sessions per week), with each session lasting approximately 60 minutes of structured rehabilitation training plus additional functional practice as prescribed. Activities are progressively graded and include fine motor tasks, object manipulation, and functional reaching and grasping exercises designed to promote neuroplasticity and motor recovery

Also known as: CIMT
Constraint-Induced Movement Therapy Group

Participants will receive task-specific upper limb rehabilitation involving functional activities, bilateral tasks, object manipulation, and daily living task practice for 45-60 minutes per session, 5 days per week for 3 weeks. Each session consists of a 45-60 minute structured rehabilitation program including warm-up (ROM and stretching), task-specific training (reaching, grasping, pegboard, coin and card tasks), and bilateral functional activities with progressive difficulty and a cool-down phase. The intervention is delivered at an intensity of 5 sessions per week for 3 weeks, totaling 15 sessions.

Also known as: TOT
Task-Oriented Training Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 45 and 65 years
  • Both male and female participants
  • First-ever unilateral ischemic or hemorrhagic stroke confirmed by imaging
  • Stroke onset in subacute to chronic phase (\>3 months post-stroke)
  • Medically stable and able to sit independently
  • Voluntary wrist extension of at least 10 degrees and finger extension of at least 10 degrees in the affected hand
  • Mini-Mental State Examination (MMSE) score \> 26
  • No significant pain or spasticity in affected upper limb (Modified Ashworth Scale \< 2)
  • Adequate sitting balance and trunk control for upper limb activities
  • Willingness and availability to complete the full intervention (3 weeks)
  • No significant musculoskeletal impairments (e.g., fractures or arthritis) affecting the upper limb

You may not qualify if:

  • Severe spasticity (Modified Ashworth Scale \> 3) or joint contractures
  • Severe aphasia, neglect, or cognitive impairments affecting task performance
  • Recurrent or bilateral stroke
  • Severe upper limb impairment
  • Joint contractures or orthopedic limitations in the upper limb
  • Active infections, skin lesions, or wounds on the upper limb
  • Severe pain during limb movement
  • Participation in other upper limb rehabilitation programs concurrently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

department of physiotherapy, Allama Iqbal Memorial Teaching Hospital

Sialkot, Punjab Province, 51310, Pakistan

Location

Related Links

MeSH Terms

Interventions

Constraint Induced Movement Therapy

Intervention Hierarchy (Ancestors)

Exercise TherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Dr Shumaila Physio, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor was blinded to group allocation to minimize assessment bias during evaluation of hand function outcomes. Participants and therapists were aware of the intervention being administered due to the nature of physiotherapy rehabilitation treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Item Description Study Type Interventional Study Design Randomized Controlled Trial Intervention Model Parallel Assignment Primary Purpose Treatment/Rehabilitation Phase N/A (Behavioral/Physiotherapy Intervention)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2026

First Posted

August 14, 2026

Study Start

July 12, 2025

Primary Completion

July 15, 2026

Study Completion (Estimated)

August 25, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

nill

Locations