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

Sponsor
Riphah International University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05380011
Collaborator
(none)
54
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2
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7.3

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Constraint Induced Movement Therapy and Bimanual Task Training
  • Other: Bimanual Task Training
N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
54 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
This will be single blinded study. The data will be coded and the analyst will also be blinded.
Primary Purpose:
Treatment
Official Title:
Effects of Bimanual Task Training With and Without Constraint-Induced Movement Therapy on Upper Limb Functions in Hemiplegic Cerebral Palsy Children
Actual Study Start Date :
May 20, 2022
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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
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.

Experimental: Group B (Bimanual Task Training)

Bimanual Task Training

Other: Bimanual 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.

Outcome Measures

Primary Outcome Measures

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

    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.

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

    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.

  3. Melbourne Assessment of Unilateral Upper Limb Function (MUUL) [4 weeks]

    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.

  4. Canadian Occupation Performance Measure (COPM) [baseline]

    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.

  5. Canadian Occupation Performance Measure (COPM) [2 weeks]

    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.

  6. Canadian Occupation Performance Measure (COPM) [4 weeks]

    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.

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

    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.

  8. Cerebral Palsy Quality Of Life scale (CP-QOL) [2 weeks]

    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.

  9. Cerebral Palsy Quality Of Life scale (CP-QOL) [4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 15 Years
Sexes Eligible for Study:
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:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Institute of rehabilitation medicine. Islamabad Pakistan

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Imran Amjad, PhD, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT05380011
Other Study ID Numbers:
  • REC/01263 Ayesha bint Ihsan
First Posted:
May 18, 2022
Last Update Posted:
May 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Riphah International University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 24, 2022