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NCT Number: NCT07764939

Comparative Effects of CIMT and TOT on Hand Function in Post Stroke Patients

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Poststroke/CVA Hemiparesis

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

department of physiotherapy, Allama Iqbal Memorial Teaching Hospital

Sialkot, Punjab Province, 51310, Pakistan

About this study

This randomized clinical trial will compare the effects of Constraint-Induced Movement Therapy (CIMT) and Task-Oriented Training (TOT) on hand function in post-stroke patients. The study will be conducted over 11 months at Allama Iqbal Memorial Teaching Hospital and Life Care Hospital, Sialkot, with 48 participants (24 per group) recruited through convenience sampling and randomly assigned to either intervention.

Eligible participants will be stroke patients aged 45-65 years in the subacute to chronic phase (>3 months), medically stable, cognitively intact, and with minimal voluntary hand movement, while those with severe neurological, cognitive, or musculoskeletal impairments will be excluded.

Group A will receive CIMT involving restriction of the unaffected limb and intensive task-specific training, while Group B will receive TOT based on functional, task-oriented activities with progressive difficulty. Both interventions will be delivered over 3 weeks (15 sessions).

Outcomes will be measured using the 9-Hole Peg Test, Jebsen-Taylor Hand Function Test, and grip strength assessment. A single-blinded design will be used with blinded outcome assessors, and data will be analyzed using SPSS-21 to compare the effectiveness of both interventions.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participants will be included if they meet the following criteria:

  • 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

Exclusion criteria

Participants will be excluded if they have:

  • 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

Treatment and study plan

Constraint-induced movement therapy

Behavioral

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

Other names: CIMT

Task-oriented Training

Behavioral

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.

Other names: TOT

Primary outcomes

  1. Nine-Hole Peg Test (NHPT)

    Time frame: Baseline to 3 weeks

    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.

  2. Jebsen-Taylor Hand Function Test (JHFT)

    Time frame: baseline to 3 weeks

    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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Constraint Induced Movement Therapy and Task-oriented Training on Hand Function in Post Stroke Patients

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 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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