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

NCT05981287 | Completed DMC

• 1 other identifier: REC/RCR & AHS/22/0720
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Balance

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

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.

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

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.

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

Interventions

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

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.

Also known as: Comparison between task oriented activities and gross motor task training

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

Gross motor task training and Conventional physical therapy (CPT) OTHER

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.

Also known as: Comparison between task oriented activities and gross motor task training

Gross motor task training and Conventional physical therapy (CPT)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Aamna Hassan

Bahawalpur, Punjab Province, 63100, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Arnab Altaf, Mphill

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: August 8, 2023
• Study Start: September 15, 2022
• Primary Completion: March 5, 2023
• Study Completion: April 5, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)