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Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy

Primary Purpose

Cerebral Palsy Spastic Diplegia

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Dynamic surface exercise training
conventional physical therapy
Sponsored by
Ayesha Hameed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy Spastic Diplegia focused on measuring trunk control, dynamic surface exercise therapy, gross motor

Eligibility Criteria

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

Inclusion Criteria Diplegic children having Cerebral Palsy Children of age 5 - 12 years Children of GMFCS- E &R level III and IV Children who can follow verbal commands Exclusion Criteria: Children with epileptic fits Children presenting with lower limb muscular contractures Children with scoliosis

Sites / Locations

  • University of Lahore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dynamic surface exercise training group

conventional physical therapy group

Arm Description

This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received a set of exercises on various dynamic surfaces along with routine physical therapy. This group underwent a 60-minutes vigorous exercise program four days a week for two months

This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received only conventional physical therapy which is based upon principles of NDT. This group underwent a 60-minutes vigorous exercise program four days a week for two months.

Outcomes

Primary Outcome Measures

Gross motor function measure- 88
The Gross Motor Function Measure (GMFM 88) is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy. It explores five areas of motor ability, which are known as dimensions: A) Lying and rolling B) Sitting C) Crawling and kneeling D) Standing E) Walking, running and jumping
trunk control measurement scale
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. total score is 58 . low score means severely impaired trunk control and a high score shows better trunk control

Secondary Outcome Measures

Full Information

First Posted
April 9, 2023
Last Updated
July 6, 2023
Sponsor
Ayesha Hameed
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1. Study Identification

Unique Protocol Identification Number
NCT05946096
Brief Title
Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy
Official Title
Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ayesha Hameed

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
The purpose of this study was to determine the effect of dynamic surface exercise treatment on trunk control and gross motor abilities in children with spastic diplegic cerebral palsy.
Detailed Description
A clinical trial was conducted to assess the impact dynamic surface exercise training on gross motor and trunk control of children with spastic diplegic cerebral palsy. The trial enrolled 38 children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. Children were randomly assigned to either the DSET or conventional physiotherapy training groups. Both groups underwent 60-minute vigorous exercise program four days a week for two months. The trunk control measurement scale was used to assess trunk control, while the GMFM-88 was used to assess gross motor function. Trunk control and gross motor function scores were obtained at the beginning, the fourth week, and the eighth week.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy Spastic Diplegia
Keywords
trunk control, dynamic surface exercise therapy, gross motor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
38 children with CP were randomly assigned to 2 groups. 1 group was interventional group and second group was control group. Both the groups were provided with therapy ( interventional group was provided with conventional therapy and intervention. control group was provided with conventional therapy only) and results were analyzed based on performance of both groups.
Masking
Outcomes Assessor
Masking Description
the outcome assessor was masked and had no idea about which participants were assigned to which group
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dynamic surface exercise training group
Arm Type
Experimental
Arm Description
This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received a set of exercises on various dynamic surfaces along with routine physical therapy. This group underwent a 60-minutes vigorous exercise program four days a week for two months
Arm Title
conventional physical therapy group
Arm Type
Active Comparator
Arm Description
This group includes 19 subjects all of which are children with spastic diplegic cerebral palsy of GMFCS levels 3 and 4. This group received only conventional physical therapy which is based upon principles of NDT. This group underwent a 60-minutes vigorous exercise program four days a week for two months.
Intervention Type
Other
Intervention Name(s)
Dynamic surface exercise training
Intervention Description
Dynamic surface exercise training involves a set of exercises that are performed on various dynamic surfaces like gym ball and vestibular swing. All these exercise provide optimal arousal as they provide proprioceptive and vestibular stimulus. This group received a set of exercises on various dynamic surfaces.These exercises were implemented for 60 minutes for four days a week for two months.And it was observed how these exercises impacted gross motor function and trunk control of children with diplegic cerebral palsy of GMFCS level 3 and 4
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Intervention Description
conventional physical therapy based on NDT involves a set of exercises that mostly include positioning exercises such as quadruped, side sitting, reaching sideways and overhead in sitting and catch and throw activities.
Primary Outcome Measure Information:
Title
Gross motor function measure- 88
Description
The Gross Motor Function Measure (GMFM 88) is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy. It explores five areas of motor ability, which are known as dimensions: A) Lying and rolling B) Sitting C) Crawling and kneeling D) Standing E) Walking, running and jumping
Time Frame
change in baseline scores and 8th week scores
Title
trunk control measurement scale
Description
The Trunk Control Measurement Scale is a clinical tool to measure trunk control in children with cerebral palsy. total score is 58 . low score means severely impaired trunk control and a high score shows better trunk control
Time Frame
change in baseline scores and 8th week scores

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 Diplegic children having Cerebral Palsy Children of age 5 - 12 years Children of GMFCS- E &R level III and IV Children who can follow verbal commands Exclusion Criteria: Children with epileptic fits Children presenting with lower limb muscular contractures Children with scoliosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayesha Hameed, DPT
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Lahore
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Dynamic Surface Exercise Training on Trunk Control and Gross Motor Functions in Children With Diplegic Cerebral Palsy

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