NCT05787132

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

4 months

First QC Date

March 15, 2023

Last Update Submit

March 31, 2023

Conditions

Cerebral Palsy

Keywords

cerebral palsyGMFC IVGMFC VBalance boardPerceptual motor therapy

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Group A (Balance Board Therapy)

EXPERIMENTAL

30 minutes of Balance board therapy along with conventional physical therapy

Other: Balance Board therapy

Group B (Perceptual Motor Therapy)

EXPERIMENTAL

30 minutes of Perceptual Motor therapy along with conventional physical therapy

Other: Perceptual Motor therapy

Interventions

Balance Board therapyOTHER

Balance board therapy will be performed. balance board therapy has been shown to improve the sitting balance in children with cerebral palsy

Group A (Balance Board Therapy)
Perceptual Motor therapyOTHER

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

Group B (Perceptual Motor Therapy)

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Umeed Rehabilitation Association

Karachi, Sindh, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Imran Amjad, PhD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bakhtawar Samejo, MS-NMPT

CONTACT

+923042923429bakhtawer.samejo@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This will be single blinded study. The data will be coded and the analyst will also be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

March 28, 2023

Primary Completion

July 30, 2023

Study Completion

August 15, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)