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Comparsion of Gross Motor Task Training and Trunk Trageted Training

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Gross motor training
Trunk targeted training
Sponsored by
khadija liaquat
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral plasy, Trunk targeted training, Gross motor trageted training, Balance

Eligibility Criteria

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

Inclusion Criteria male & female. GMFCS III V Age 8to12 years Diplegic cerebral palsy Hypoxic brain injury Diagnosed with a gross motor delay by the pediatrician.

Exclusion Criteria:

  • Children having a cognitive or psychiatric disorder. Children with known congenital limb anomaly Children with some chromosomal defect

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gross motor training activity

Trunk targeted training

Arm Description

Gross motor training activity It includes training of motor components of child grossly

In this training group the particpiants were given the exercises that were focused the truck muscles

Outcomes

Primary Outcome Measures

Functional mobility assessment
It classifies the functional mobility of children between ages 4-18 years of age with cerebral palsy. The scale can be used to classify children's functional mobility, document change over time in the same child and to document change. The FMS rates walking ability at three specific distances, 5, 50 and 500 meters, (or 5, 50, 500 yards). This represents the child's mobility in the home, at school and in the community setting
Pediatric Berg Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children and children with cerebral palsy. 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.
Goniometer
This is an instrument which is used to measure the range of motion

Secondary Outcome Measures

Full Information

First Posted
August 6, 2021
Last Updated
June 22, 2023
Sponsor
khadija liaquat
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1. Study Identification

Unique Protocol Identification Number
NCT04995952
Brief Title
Comparsion of Gross Motor Task Training and Trunk Trageted Training
Official Title
Comparison Of Gross Motor Task Training And Trunk Targeted Training On Balance, Range Of Motion And Community Participation In Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
khadija liaquat

4. Oversight

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

5. Study Description

Brief Summary
In this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children
Detailed Description
In this project a randomized clinical trial was be conducted to determine the comparison of gross motor training technique and trunk training therapy on balance, Range of motion and community participation in children with diplegic cerebral palsy. This study aim to compare the effects of both the treatments to improve balance, quality of life and community participation. The sample was being collected according to inclusion and exclusion criteria using a convenient sampling technique within period of 6 months. The participants were be randomly allocated in two groups' .Group A received gross motor training which included sit to stand, step up and walking for 1 hour/day/3 days a week for 3 months. Group B received trunk targeted training for 1 hour/day/3 days a week for 3 months which included treadmill walking, reaching forward to the limits of stability and specific truncal activities with vibration and proprioception. The post treatment assessments was done via early assessment of balance, goniometer, and functional mobility assessment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral plasy, Trunk targeted training, Gross motor trageted training, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gross motor training activity
Arm Type
Experimental
Arm Description
Gross motor training activity It includes training of motor components of child grossly
Arm Title
Trunk targeted training
Arm Type
Experimental
Arm Description
In this training group the particpiants were given the exercises that were focused the truck muscles
Intervention Type
Behavioral
Intervention Name(s)
Gross motor training
Intervention Description
Gross motor training activity (1 hour session, 3 times a week for 3 months). Pre ad post assessments will be taken. The Gross motor training activity will include: sit to stand, step-ups and walking. The sit to stand will be performed for 20 minutes involving 20 repetitions. We will progress from high seat sit to stand to low seat sit to stand. The step up will progress initially from a bench having low height to high height and then to stepping of stairs for 20 minutes involving 30 repetitions. The walking will occur from 3m walk and then increasing the distance
Intervention Type
Behavioral
Intervention Name(s)
Trunk targeted training
Intervention Description
Trunk targeted training (1hour session, 3 times a week for 3 months). Pre and Post assessment will be evaluated. The trunk targeted training will include: weight supported treadmill walk, specific trunk exercises with vibration therapy and reaching forward to the limits of stability. Specific trunk exercises will involve stride sitting to standing, sitting on a roll and moving the roll in diagonal and forward backward directions along with giving vibrational therapy on wobble board, side sitting. This activity will be performed for 30 minutes with 30 repetitions. Reaching forward to the limits of stability exercises will be performed. Asking the children to hold objects from right hand while reaching for an object on left side and vice versa. This will be performed for 20 minutes having 20 repetitions.
Primary Outcome Measure Information:
Title
Functional mobility assessment
Description
It classifies the functional mobility of children between ages 4-18 years of age with cerebral palsy. The scale can be used to classify children's functional mobility, document change over time in the same child and to document change. The FMS rates walking ability at three specific distances, 5, 50 and 500 meters, (or 5, 50, 500 yards). This represents the child's mobility in the home, at school and in the community setting
Time Frame
10 minutes
Title
Pediatric Berg Balance Scale
Description
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children and children with cerebral palsy. 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
20 minutes
Title
Goniometer
Description
This is an instrument which is used to measure the range of motion
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria male & female. GMFCS III V Age 8to12 years Diplegic cerebral palsy Hypoxic brain injury Diagnosed with a gross motor delay by the pediatrician. Exclusion Criteria: Children having a cognitive or psychiatric disorder. Children with known congenital limb anomaly Children with some chromosomal defect
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof S Shakil Ur Rehman, Phd
Organizational Affiliation
Riphah International University
Official's Role
Study Director
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparsion of Gross Motor Task Training and Trunk Trageted Training

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