CClinicalTrials.gg
CompletedNCT05380011Updated Nov 28, 2022

Bimanual Task Training and Constraint-Induced Movement Therapy in Hemiplegic Cerebral Palsy Children

An interventional study of Constraint Induced Movement Therapy and Bimanual Task Training and Bimanual Task Training in Hemiplegic Cerebral Palsy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2022-11-28.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
5 Years to 15 Years
Sex
All
01

Study summary

Various studies have been done comparing the individual effects of the two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children, but this study will compare the effects of combined interventions with a single intervention. This study will contribute to the upper motor function in hemiplegic cerebral palsy children i.e. manual dexterity, grasp and release function, quality and efficacy of movement, combined bimanual use of both hands and coordination, as a result of two intervention protocols.

Read the detailed description

Various studies have been done comparing the individual effects of these two interventions of Constraint-Induced Movement Therapy and Bimanual Task Training in Hemiplegic Cerebral Palsy Children. But the literature comparing the effects of combined interventions of these two with either of the single intervention is sparse and limited, utilizing different clinical experiences and tools for the respective study. This study will contribute to the upper motor function in hemiplegic cerebral palsy children by comparing the effects of combined interventions with a single intervention with its overall effects in the respective population i.e. manual dexterity, grasp and release function, quality and efficacy of movement, combined bimanual use of both hands and coordination, as a result of two intervention protocols. A total of 54 patients diagnosed with Hemiplegic Cerebral Palsy will be selected for data collection according to the inclusion criteria. Patients will be divided into two groups, Group A and Group B. Group A will receive Bimanual Task Training and Constraint-Induced Movement Therapy (CIMT) and Group B will receive Bimanual Task Training alone. Constraint-Induced Movement Therapy (CIMT) will be performed 1.5 hours daily, with the constraint of 6 hours applied daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks, along with, Bimanual Task Training with the practice of each task for 15 to 30 minutes, 1.5 hours daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks respectively in Group A, whereas, Bimanual Task Training will be performed with the practice of each task for 15 to 30 minutes, 1.5 hours daily, thrice-weekly sessions, with a total of 10 to 12 sessions, for 4 weeks in Group B. Data will be collected at baseline, at 2 weeks and at 4 weeks after intervention from both groups. Upper Limb Functions will be measured using the Melbourne Assessment of Unilateral Upper Limb Function (MUUL) and Canadian Occupational Performance Measure (COPM) and Quality of life will be measured using Cerebral Palsy Quality Of Life measure (CP-QOL).

02

Conditions studied

  • Hemiplegic Cerebral Palsy

Keywords

  • Constraint Induced Movement Therapy
  • Bimanual Task Training
  • Cerebral Palsy
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's enrollment of 54 is above the median of 30 across 537 interventional studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Children with both Gender (Male and Female).
  • Age between 5 to 15 years.
  • Hemiplegic Cerebral Palsy Children.
  • Patients fulfilling the criteria of Constraint Induced Movement Therapy (CIMT) i.e. wrist extension 20 degree, MCP and IP extension 10 degree.

Exclusion criteria

Exclusion Criteria:

  • Hemiplegic Cerebral Palsy children due to Traumatic Brain Injury.
  • Patients having cognitive impairments.
  • Hemiplegic Cerebral Palsy children with rigid deformities of upper extremity.
  • Patients having associated Neurological Pathologies.
  • Patients who are unable to follow treatment plan.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
54 participants (actual)

Study arms

  • Experimental
    Group A (CIMT and Bimanual Task Training)

    Constraint Induced Movement Therapy and Bimanual Task Training

    Other: Constraint Induced Movement Therapy and Bimanual Task Training

  • Experimental
    Group B (Bimanual Task Training)

    Bimanual Task Training

    Other: Bimanual Task Training

Interventions

  • OtherConstraint Induced Movement Therapy and Bimanual Task Training

    Constraint-Induced Movement Therapy and Bimanual Task Training will be performed. Constraint-Induced Movement Therapy has been shown to improve the uni-manual capacity of the impaired limb as well as improvement in quality and efficiency of movement and greater grasp function, whereas Bimanual Task Training has been shown to improve bimanual task performance, bilateral spontaneous use of affected limb and better bimanual coordination during daily life activities.

  • OtherBimanual Task Training

    Bimanual Task Training will be performed. Bimanual Task Training has been shown to improve bimanual task performance, bilateral spontaneous use of affected limb and better bimanual coordination during daily life activities.

06

What researchers measure

Primary outcomes

  1. Melbourne Assessment of Unilateral Upper Limb Function (MUUL)

    Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.

    Time frame: baseline

  2. Melbourne Assessment of Unilateral Upper Limb Function (MUUL)

    Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.

    Time frame: 2 weeks

  3. Melbourne Assessment of Unilateral Upper Limb Function (MUUL)

    Melbourne Assessment of Unilateral Upper Limb Function (MUUL) is considered one of the reliable tools to measure upper limb function. It consists of 16-items to measure the quality of unilateral upper limb function. Items of the assessment involve reach, grasp, and release. It shows excellent construct and inter-rater validity as well as its shows good reliability for treatment planning and clinical decision making. It has a total 16 number of items. Scoring is completed for 37 item sub-scores using a three, four or five-point scale and individually defined scoring criteria for each item. The maximum score is 122 and the minimum score is 0, where higher scores reflect the greater quality of upper limb movement.

    Time frame: 4 weeks

  4. Canadian Occupation Performance Measure (COPM)

    It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.

    Time frame: baseline

  5. Canadian Occupation Performance Measure (COPM)

    It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.

    Time frame: 2 weeks

  6. Canadian Occupation Performance Measure (COPM)

    It is a client-centred outcome measure that helps the client to identify occupational performance issues and rates performance and satisfaction pre and post-intervention. This tool involves the first identification of problems or daily occupations of importance that are needed or expected to do, and then secondly, the client is asked to rate the importance of each occupation using a 10-point rating scale. In the third step. the client selects up to 5 most important problems to be addressed in intervention and the therapist enters the chosen problems and their importance ratings in the scoring section. In the fourth step, the client is asked to use a 10-point scale to rate their own level of performance and satisfaction with performance for 5 identified problems.

    Time frame: 4 weeks

  7. Cerebral Palsy Quality Of Life scale (CP-QOL)

    The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP. Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.

    Time frame: baseline

  8. Cerebral Palsy Quality Of Life scale (CP-QOL)

    The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP. Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.

    Time frame: 2 weeks

  9. Cerebral Palsy Quality Of Life scale (CP-QOL)

    The Cerebral Palsy (CP) Quality Of Life scale-child is a condition-specific Quality Of Life (QOL) questionnaire designed for children with CP. Feasibility, sensitivity, Instrument validity and internal consistency of both self-and proxy-report questionnaires are good and are becoming a fundamental component of public health surveillance. QOL is broadly defined as a subjective multidimensional concept for assessing a person's wellbeing across numerous life indicators. The child self-report form contains 52 items and is divided into areas: well-being and social acceptance, functionality, participation and physical health, emotional well-being and self-esteem, access to services and pain and impact disability. All items are rated from 1 to 9, except for one item in the pain and impact disability domain, which is rated on a 5-point scale. All responses are then converted into scale scores between 0 to 100. Higher scores mean a higher quality of life and vice versa.

    Time frame: 4 weeks

07

Study locations

1 site
  • National Institute of rehabilitation medicine.
    Islamabad, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05380011
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
May 18, 2022
Start date
May 20, 2022
Primary completion
Nov 20, 2022
Completion
Nov 20, 2022
Last update
Nov 28, 2022

Study contacts

Imran Amjad, PhD
principal investigator · Riphah International University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion