Clinical trial NCT05380011: Bimanual Task Training and Constraint-Induced Movement Therapy in Hemiplegic Cerebral Palsy Children
Official title: Effects of Bimanual Task Training With and Without Constraint-Induced Movement Therapy on Upper Limb Functions in Hemiplegic Cerebral Palsy Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Constraint Induced Movement Therapy
Bimanual Task Training
Cerebral Palsy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 54
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
timeFrame: baseline
measure: Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
timeFrame: 2 weeks
measure: Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
timeFrame: 4 weeks
measure: Canadian Occupation Performance Measure (COPM)
timeFrame: baseline
measure: Canadian Occupation Performance Measure (COPM)
timeFrame: 2 weeks
measure: Canadian Occupation Performance Measure (COPM)
timeFrame: 4 weeks
measure: Cerebral Palsy Quality Of Life scale (CP-QOL)
timeFrame: baseline
measure: Cerebral Palsy Quality Of Life scale (CP-QOL)
timeFrame: 2 weeks
measure: Cerebral Palsy Quality Of Life scale (CP-QOL)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National Institute of rehabilitation medicine.
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References: