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

NCT05380011 | Completed

• 1 other identifier: REC/01263 Ayesha bint Ihsan
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegic Cerebral Palsy

Keywords

Constraint Induced Movement Therapy; Bimanual Task Training; Cerebral Palsy

Outcome Measures

Primary Outcomes (9)

• 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.

  baseline

• 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.

  2 weeks

• 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.

  4 weeks

• 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.

  baseline

• 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.

  2 weeks

• 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.

  4 weeks

• 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.

  baseline

• 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.

  2 weeks

• 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.

  4 weeks

Study Arms (2)

Group A (CIMT and Bimanual Task Training)

EXPERIMENTAL

Constraint Induced Movement Therapy and Bimanual Task Training

Other: Constraint Induced Movement Therapy and Bimanual Task Training

Group B (Bimanual Task Training)

EXPERIMENTAL

Bimanual Task Training

Other: Bimanual Task Training

Interventions

Constraint Induced Movement Therapy and Bimanual Task Training OTHER

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.

Group A (CIMT and Bimanual Task Training)

Bimanual Task Training OTHER

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.

Group B (Bimanual Task Training)

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

National Institute of rehabilitation medicine.

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Imran Amjad, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This will be single blinded study. The data will be coded and the analyst will also be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2022
• First Posted: May 18, 2022
• Study Start: May 20, 2022
• Primary Completion: November 20, 2022
• Study Completion: November 20, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)