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Dynamic Surface Exercise and Trunk Targeted Training in Children With Spastic Cerebral Palsy

Primary Purpose

Spastic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
dynamic surface exercise
trunk targeted training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spastic Cerebral Palsy focused on measuring Balance, Cerebral palsy, Dynamic surface training, Gross motor function.

Eligibility Criteria

5 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children who can follow the therapist instructions Children who have not had any procedure and surgery within the past six months Both genders male and female Age 5 to 10 years Spastic cerebral palsy Exclusion Criteria: Children with innate musculoskeletal diseases, developing Central nervous system diseases and history of orthopedic surgery Children with genetic disorders and other severe diseases other than cerebral palsy Children who had Botulinum Toxin A (BoNT-A) injection during the last 6 months or had seizures during the last one year were excluded from the study Children with visual impairement Children with hearing Impairemen

Sites / Locations

  • Shahida Islam Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dynamic surface exercise with conventional therapy

trunk targeted training with conventional therapy

Arm Description

the experimental group undergo conventional physical therapy and additional dynamic surface exercise training thrice a week for 2 months dynamic surface training will include gym balls , bolster or platform swing

the group will receive conventional physical therapy and additional trunk targeted training thrice a week for 2 months.

Outcomes

Primary Outcome Measures

pedriatic balance scale
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
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
Trunk control measurement scale
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.

Secondary Outcome Measures

Full Information

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

Unique Protocol Identification Number
NCT05810779
Brief Title
Dynamic Surface Exercise and Trunk Targeted Training in Children With Spastic Cerebral Palsy
Official Title
Comparison of Dynamic Surface Exercise and Trunk Targeted Training on Gross Motor Function, Balance and Trunk Control in Children With Spastic Cerebral Palsy
Study Type
Interventional

2. Study Status

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

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 describe the comparative effects of dynamic surface training and trunk targeted training in order to ensure which method is best in improving gross motor function , balance and trunk control in children with spastic cerebral palsy . this will be randomized control study which includes participants with age 5 to 10 years
Detailed Description
Cerebral palsy (CP) is a well-documented nonprogressive neurodevelopmental condition commencing in early childhood and persisting throughout life. The neuromuscular deficits observed in children with CP include abnormal muscle tone that affects posture, movement, alteration of balance and motor coordination, decrease in strength, and loss of selective motor control, leading to functional limitation. Neurodevelopmental principles state that the control of movement proceeds from the proximal to the distal part of the body. 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. Using dynamic surface for exercise provides proprioceptive and vestibular feedback about the position of their body segments in space with adaptive motor control response to stimuli. Standard physiotherapy based on motor-learning principle is task-specific training, which involves practice of functional movements in activities of daily living. This study aims to describe the comparative effects of dynamic surface training and trunk targeted training in order to ensure which method is best in improving gross motor function , balance and trunk control in children with spastic cerebral palsy . this will be randomized control study which includes participants with age 5 to 10 years. Data will be taken from shahida islam teaching hospital Lodhran after taking consent, techniques will be applied and data will be recorded. Assessment will be made by using pedriatics balance scale , gross motor function measure (GMFM 66) and trunk control measurement scale (TCMS) for determining balance and gross motor function and trunk stability . The collective data will be analyzed in Statistical Package for Social Sciences (SPSS) 27.0

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Cerebral Palsy
Keywords
Balance, Cerebral palsy, Dynamic surface training, Gross motor function.

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
dynamic surface exercise with conventional therapy
Arm Type
Experimental
Arm Description
the experimental group undergo conventional physical therapy and additional dynamic surface exercise training thrice a week for 2 months dynamic surface training will include gym balls , bolster or platform swing
Arm Title
trunk targeted training with conventional therapy
Arm Type
Active Comparator
Arm Description
the group will receive conventional physical therapy and additional trunk targeted training thrice a week for 2 months.
Intervention Type
Other
Intervention Name(s)
dynamic surface exercise
Other Intervention Name(s)
comparison between dynamic surface exercise and trunk targeted training
Intervention Description
Optimal arousal Physio ball Make the child bounce, active/passive on the Swiss ball, slow/fast 5 times 5 sets Combined frontal and transverse plane movements Physio ball/ bolster High sitting: one hand weight bearing followed by trunk rotation to reach the toy on opposite side 5-7 each side 1 set Combined frontal and transverse plane movements Platform swing Reaching the toy with both the hands kept overhead and 45°-60° diagonal to the mid line 5-7 times each side 1 set
Intervention Type
Other
Intervention Name(s)
trunk targeted training
Other Intervention Name(s)
comparison between dynamic surface exercise and trunk targeted training
Intervention Description
trunk training group (TTG) consist of exercises and activities focusing on the activation of the trunk muscles, pelvic control and proximal stabilization and these were combined with the trunk and gluteal muscle strengthening exercises. The trunk elongation activities, the facilitation of spinal extension, weight shifting and weight-bearing activities The children in the TTG received 45-75-minute of physiotherapy twice a week for 8 weeks
Primary Outcome Measure Information:
Title
pedriatic balance scale
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
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
Title
Trunk control measurement scale
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children who can follow the therapist instructions Children who have not had any procedure and surgery within the past six months Both genders male and female Age 5 to 10 years Spastic cerebral palsy Exclusion Criteria: Children with innate musculoskeletal diseases, developing Central nervous system diseases and history of orthopedic surgery Children with genetic disorders and other severe diseases other than cerebral palsy Children who had Botulinum Toxin A (BoNT-A) injection during the last 6 months or had seizures during the last one year were excluded from the study Children with visual impairement Children with hearing Impairemen
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arnab Altaf, Mphill
Phone
03064585776
Email
arnab.altaf@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Muneeb khan, Ph.D
Phone
03367993611
Email
muneeb.khan@riphah.edu.pk; muneebkhan2001@gmail.com
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
Shahida Islam Teaching Hospital
City
Lodhran
State/Province
Punjab
ZIP/Postal Code
59320
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
farwa batool, DPT
Phone
03067481183
Email
drfarwabatool81@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Dynamic Surface Exercise and Trunk Targeted Training in Children With Spastic Cerebral Palsy

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