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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Balance Board therapy; Other: Perceptual Motor therapy

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).

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bakhtawar Samejo, MS-NMPT; Phone Number: +923042923429; Email: bakhtawer.samejo@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Recruiting
      • Al-Umeed Rehabilitation Association
      • Contact: Bakhtawar Samejo, DPT; Phone Number: +923042923429; Email: bakhtawer.samejo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Balance Board Therapy); 30 minutes of Balance board therapy along with conventional physical therapy	Other: Balance Board therapy; Balance board therapy will be performed. balance board therapy has been shown to improve the sitting balance in children with cerebral palsy
Experimental: Group B (Perceptual Motor Therapy); 30 minutes of Perceptual Motor therapy along with conventional physical therapy	Other: Perceptual Motor therapy; Perceptual motor therapy will be performed, it has been shown to improve dynamic sitting in children with cerebral palsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline
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	4th week
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	8th week
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	12th week
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	Baseline
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	4th week
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	8th week
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	12th week

Collaborators and Investigators

• Sponsor: Riphah International University

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): August 15, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: cerebral palsy; GMFC IV; GMFC V; Balance board; Perceptual motor therapy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: REC/ 01347 Bakhtawar Samejo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No