Clinical trial NCT05787132: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: cerebral palsy
GMFC IV
GMFC V
Balance board
Perceptual motor therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 88
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Gross Motor Function Measure Scale (GMFM 88)
timeFrame: Baseline
measure: Gross Motor Function Measure Scale (GMFM 88)
timeFrame: 4th week
measure: Gross Motor Function Measure Scale (GMFM 88)
timeFrame: 8th week
measure: Gross Motor Function Measure Scale (GMFM 88)
timeFrame: 12th week
measure: Trunk Control Motor Scale (TCMS)
timeFrame: Baseline
measure: Trunk Control Motor Scale (TCMS)
timeFrame: 4th week
measure: Trunk Control Motor Scale (TCMS)
timeFrame: 8th week
measure: Trunk Control Motor Scale (TCMS)
timeFrame: 12th week
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Al-Umeed Rehabilitation Association
state: Sindh
Study officials:
affiliation: Riphah International University
name: Imran Amjad, PhD
role: PRINCIPAL_INVESTIGATOR
References: