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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05787132
• Other study ID #: REC/ 01347 Bakhtawar Samejo
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2023
• Est. completion date: August 15, 2023

Study information

• Verified date: March 2023
• Source: Riphah International University
• Contact: Bakhtawar Samejo, MS-NMPT
• Phone: +923042923429
• Email: bakhtawer.samejo[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: August 15, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

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
• Perceptual Motor therapy
Perceptual motor therapy will be performed, it has been shown to improve dynamic sitting in children with cerebral palsy.

Locations

Country	Name	City	State
Pakistan	Al-Umeed Rehabilitation Association	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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