Clinical trial NCT05981287: Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training.
Official title: Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training on Balance, Trunk Control and Functional Mobility in Children With Cerebral Palsy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to find the comparison of task oriented activity based neurodevelopmental principles and gross motor task training on balance, trunk control and functional mobility in children with cerebral palsy.

Detailed description: Cerebral palsy (CP) being a non-progressive neurodevelopmental condition, is the leading cause of chronic disability in children, making them physically and mentally handicapped and socially unapproachable. The low tone of the torso also causes postural instability, lack of mobility, and muscle stiffness in the legs. Therapeutic intervention for children with cerebral palsy should be composed of goal directed, functional, and meaningful activities by considering the clinical type, degree of disability, cognitive level and interest of the child. The trunk being the central key point of the body, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional mobility. Since children with cerebral palsy show damage not only in the function and an ability to accomplish tasks, but also in the quality of movement. The objective of this study will be to help clinicians regarding the effectiveness of task-oriented training and gross motor functional training for children with cerebral palsy.

This will be a Randomized Clinical Trial in which participants of age 5 - 12 years with cerebral palsy will be assigned randomly for the study. Population will be taken from Physical Therapy Department of Agile Rehabilitation Complex, Bahawalpur. After taking consent, demographics including age, gender and birth history etc. will be recorded. Questionnaires will be distributed among parents and their responses will be collected. Questionnaires for trunk impairment scale, postural assessment scale, pediatric balance scale and GMFM-88 will be used as tools of assessment. The collected data will be analyzed in Statistical Package for the Social Sciences (SPSS) 27.0.

Eligibility criteria: Inclusion Criteria:

* Children with spastic cerebral palsy
* Both boys and girls
* Age 5 - 12 years old
* Able to follow verbal commands
* Having level I or II of GMFCS

Exclusion Criteria:

* Uncooperative
* On antiepileptic and anti-spastic medications
* Having visual or intellectual impairments
* Having hearing deficit
* With any cardiac anomalies affecting exercise tolerance
* Less than 6-month post-orthopedic surgery or post-botulinum toxin injections

Primary outcomes:
measure: Pediatric Balance Scale - PBS
timeFrame: 2 months
measure: Trunk Control Measurement Scale - TCMS
timeFrame: 2 months
measure: Gross Motor Function Measure 88 - GMFM 88
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bahawalpur
country: Pakistan
facility: Aamna Hassan
state: Punjab
Study officials:
affiliation: Riphah International University
name: Arnab Altaf, Mphill
role: PRINCIPAL_INVESTIGATOR
References: