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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
Gross motor task training and Conventional physical therapy (CPT)
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Balance

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aamna Hassan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Gross motor task training and Conventional physical therapy (CPT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 4, 2023
Last Updated
July 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05981287
Brief Title
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

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2022 (Actual)
Primary Completion Date
March 5, 2023 (Actual)
Study Completion Date
April 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Gross motor task training and Conventional physical therapy (CPT)
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Task-oriented activities based on NDT (TOA-NDT) principle and Conventional Physical Therapy
Other Intervention Name(s)
Comparison between task oriented activities and gross motor task training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Gross motor task training and Conventional physical therapy (CPT)
Other Intervention Name(s)
Comparison between task oriented activities and gross motor task training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale - PBS
Description
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.
Time Frame
2 months
Title
Trunk Control Measurement Scale - TCMS
Description
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.
Time Frame
2 months
Title
Gross Motor Function Measure 88 - GMFM 88
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnab Altaf, Mphill
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aamna Hassan
City
Bahawalpur
State/Province
Punjab
ZIP/Postal Code
63100
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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