Comparison of Task-oriented Activity Based Neurodevelopmental Principles and Gross Motor Task Training.

Cerebral Palsy Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05981287
• Other study ID #: REC/RCR & AHS/22/0720
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: April 5, 2023

Study information

• Verified date: July 2023
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 5, 2023
• Est. primary completion date: March 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.
• Gross motor task training and Conventional physical therapy (CPT)
This will be a randomized clinical trial. patients are divided into two groups. one of them will undergo task-oriented activities along with conventional physical therapy treatment, while the other will undergo gross motor task training along with conventional physical therapy treatment. Purpose is to determine that which of them has greater benefit in improving balance trunk control and functional mobility in children with cerebral palsy.

Locations

Country	Name	City	State
Pakistan	Aamna Hassan	Bahawalpur	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pediatric Balance Scale - PBS	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.	2 months
Primary	Trunk Control Measurement Scale - TCMS	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.	2 months
Primary	Gross Motor Function Measure 88 - GMFM 88	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.	2 months