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Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Balance Board therapy
Perceptual Motor therapy
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 cerebral palsy, GMFC IV, GMFC V, Balance board, Perceptual motor therapy

Eligibility Criteria

2 Years - 5 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who have been diagnosed with CP GMFC level IV and V Both Male/Female Participants with the age ranges from 1.5 years to 5 years Exclusion Criteria: Patients diagnosed with GMFC level I, II and III Participants taking botulinum toxin Participants diagnosed with auditory and visual impairments Participants diagnosed with mental impairments/ unable to understand the commands Participants diagnosed with any other comorbid conditions like (obesity, cardiovascular impairments) Participants who are not willing to participate

Sites / Locations

  • Al-Umeed Rehabilitation AssociationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A (Balance Board Therapy)

Group B (Perceptual Motor Therapy)

Arm Description

30 minutes of Balance board therapy along with conventional physical therapy

30 minutes of Perceptual Motor therapy along with conventional physical therapy

Outcomes

Primary Outcome Measures

Gross Motor Function Measure Scale (GMFM 88)
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Gross Motor Function Measure Scale (GMFM 88)
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Gross Motor Function Measure Scale (GMFM 88)
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Gross Motor Function Measure Scale (GMFM 88)
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Trunk Control Motor Scale (TCMS)
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Trunk Control Motor Scale (TCMS)
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Trunk Control Motor Scale (TCMS)
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Trunk Control Motor Scale (TCMS)
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58

Secondary Outcome Measures

Full Information

First Posted
March 15, 2023
Last Updated
March 31, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05787132
Brief Title
Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.
Official Title
Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 15, 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
No

5. Study Description

Brief Summary
Various studies have worked on the sitting balance of cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level I-III with a sample greater than 30, there is no data available to compare the effect of a balance board and perceptual motor therapy to improve sitting in GMFCS level IV and V with a sample greater than 30. This study will add the authenticity to literature with a large sample size and affect the severity of the condition.
Detailed Description
This study will compare the effect of balance board therapy and Perceptual motor therapy to improve sitting in children with Cerebral palsy. Previous studies have worked on the sitting balance of cerebral palsy (CP) with Gross Motor Function Classification System (GMFCS) level I-III with a sample greater than 30, there is no data available to compare the effect of a balance board and perceptual motor therapy to improve sitting in GMFC level IV and V with a sample greater than 30. This study will add the authenticity to literature with large sample size and affect the severity of the condition. In addition, the patients with diagnosed Cerebral Palsy with GMFCS levels IV and V will be benefited from this study; an exercise program will help them to improve their sitting ability. A total of 88 Cerebral palsy patients will be included by dividing them into two groups (A, B). 1 hour of exercise session will be performed three times per week for 12 weeks with a total of 36 sessions. Both groups will receive 30 minutes of conventional physical therapy. In addition, group A will receive balance board therapy in the remaining 30 minutes while Group B will receive Perceptual motor therapy in the remaining 30 minutes. Data will be collected at baseline, at 4 weeks, at 8 weeks and at 12 weeks after intervention from both groups. The sitting balance will be measured by using Gross Motor Function Measure Scale (GMFM 88) and Trunk Control Motor Scale (TCMS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, GMFC IV, GMFC V, Balance board, Perceptual motor therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
This will be single blinded study. The data will be coded and the analyst will also be blinded.
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (Balance Board Therapy)
Arm Type
Experimental
Arm Description
30 minutes of Balance board therapy along with conventional physical therapy
Arm Title
Group B (Perceptual Motor Therapy)
Arm Type
Experimental
Arm Description
30 minutes of Perceptual Motor therapy along with conventional physical therapy
Intervention Type
Other
Intervention Name(s)
Balance Board therapy
Intervention Description
Balance board therapy will be performed. balance board therapy has been shown to improve the sitting balance in children with cerebral palsy
Intervention Type
Other
Intervention Name(s)
Perceptual Motor therapy
Intervention Description
Perceptual motor therapy will be performed, it has been shown to improve dynamic sitting in children with cerebral palsy.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure Scale (GMFM 88)
Description
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Time Frame
Baseline
Title
Gross Motor Function Measure Scale (GMFM 88)
Description
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Time Frame
4th week
Title
Gross Motor Function Measure Scale (GMFM 88)
Description
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Time Frame
8th week
Title
Gross Motor Function Measure Scale (GMFM 88)
Description
The GMFM is standardized tool for measuring the change in gross motor function in children with cerebral palsy. GMFM-88 is four-point ordinal scale (0-3) with 88 items categorized in to 5 dimensions such as: lying and rolling (17 items), sitting (20 items), crawling and kneeling (14 items), standing (13 items), and walking, running and jumping (24 items). the average score ranges from 0-100. Higher scores indicate better capacity. The GMFM-88 reliability values range from 0.87 to 0.99
Time Frame
12th week
Title
Trunk Control Motor Scale (TCMS)
Description
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Time Frame
Baseline
Title
Trunk Control Motor Scale (TCMS)
Description
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Time Frame
4th week
Title
Trunk Control Motor Scale (TCMS)
Description
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Time Frame
8th week
Title
Trunk Control Motor Scale (TCMS)
Description
Trunk control motor scale consist of 15 items which are used to assess the sitting balance of trunk control during functional activities such as: (a) while static condition (b) while dynamic condition. TCMS is two, three and four-point ordinal scale with the total score ranges from 0 to 58
Time Frame
12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who have been diagnosed with CP GMFC level IV and V Both Male/Female Participants with the age ranges from 1.5 years to 5 years Exclusion Criteria: Patients diagnosed with GMFC level I, II and III Participants taking botulinum toxin Participants diagnosed with auditory and visual impairments Participants diagnosed with mental impairments/ unable to understand the commands Participants diagnosed with any other comorbid conditions like (obesity, cardiovascular impairments) Participants who are not willing to participate
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bakhtawar Samejo, MS-NMPT
Phone
+923042923429
Email
bakhtawer.samejo@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al-Umeed Rehabilitation Association
City
Karachi
State/Province
Sindh
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bakhtawar Samejo, DPT
Phone
+923042923429
Email
bakhtawer.samejo@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of the Balance Board and Perceptual Motor Therapy in Children With Cerebral Palsy.

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