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Clinical Trials/NCT05981287
NCT05981287CompletedNot Applicable

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.

Riphah International University1 site in 1 country20 target enrollmentStarted: September 15, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Locations
1
Primary Endpoint
Pediatric Balance Scale - PBS

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy

Experimental

The experimental group undergo conventional physical therapy and additional task-oriented activities based on NDT (TOT-NDT) principle 10 - 36 sessions in 5-8 weeks, 2 to 6 days per sessions.

Intervention: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy (Other)

Gross motor task training and Conventional physical therapy (CPT)

Active Comparator

This group will receive conventional physical therapy and additional gross motor task training 10-36 sessions in 5-8 weeks, 2 to 6 days per sessions.

Intervention: Gross motor task training and Conventional physical therapy (CPT) (Other)

Outcomes

Primary Outcomes

Pediatric Balance Scale - PBS

Time Frame: 2 months

Pediatric balance scale is an outcome measurement tool used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

Trunk Control Measurement Scale - TCMS

Time Frame: 2 months

Trunk Control Measurement Scale is the clinical tool to measure trunk control in children with cerebral palsy. Control of muscles is necessary to maintain stability around the trunk.

Gross Motor Function Measure 88 - GMFM 88

Time Frame: 2 months

The Gross Motor Function Measure (GMFM) is an observational clinical tool designed to evaluate change in gross motor function in children with cerebral palsy. There are two versions of the GMFM - the original 88-item measure (GMFM-88) and the more recent 66-item GMFM (GMFM-66). The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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