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

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT05981287
Collaborator
(none)
20
1
2
6.6
3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
  • Other: Gross motor task training and Conventional physical therapy (CPT)
N/A

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
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Sep 15, 2022
Actual Primary Completion Date :
Mar 5, 2023
Actual Study Completion Date :
Apr 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy

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.

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.
Other Names:
  • Comparison between task oriented activities and gross motor task training
  • Active Comparator: Gross motor task training and Conventional physical therapy (CPT)

    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.

    Other: 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.
    Other Names:
  • Comparison between task oriented activities and gross motor task training
  • Outcome Measures

    Primary Outcome Measures

    1. Pediatric Balance Scale - PBS [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.

    2. Trunk Control Measurement Scale - TCMS [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.

    3. Gross Motor Function Measure 88 - GMFM 88 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aamna Hassan Bahawalpur Punjab Pakistan 63100

    Sponsors and Collaborators

    • Riphah International University

    Investigators

    • Principal Investigator: Arnab Altaf, Mphill, Riphah International University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Riphah International University
    ClinicalTrials.gov Identifier:
    NCT05981287
    Other Study ID Numbers:
    • REC/RCR & AHS/22/0720
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Riphah International University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 8, 2023