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Clinical Trials/NCT06462859
NCT06462859
Completed
N/A

Effect of Sensory Integration on Motor Function, Balance, and Trunk Control in Diplegic Cerebral Palsy

Halic University1 site in 1 country20 target enrollmentJanuary 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diplegic Cerebral Palsy
Sponsor
Halic University
Enrollment
20
Locations
1
Primary Endpoint
Gross Motor Function Measure-88 (GMFM-88)
Status
Completed
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to compare the effects of sensory integration therapy (SIT) applied in addition to neurodevelopmental treatment (NDT) on Motor Function, Balance, and Trunk Control in diplegia cerebral palsy

Detailed Description

Cerebral palsy is the most frequent motor disability affecting children. The condition is characterized by problems with postural control and balance, which are due to the central nervous system being compromised by a brain lesion. In sensory processing, the steps include receiving, organizing, and interpreting sensory information, followed by generating an appropriate response. Children develop motor skills through sensory experiences. Sensory integration therapy leads to enhanced body awareness, motor planning abilities, and coordination between both sides of the body. Literature studies have demonstrated the effectiveness of sensory integration therapy in improving motor functions in children with diplegia type CP. However, there is a notable lack of research on how sensory integration therapy, in addition to neurodevelopmental treatment (NDT), affects balance and trunk control in these children. This study aims to bridge this gap by evaluating the impact of sensory integration therapy on gross motor function, balance, and trunk control in children with diplegia type CP when used as an adjunct to NDT.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
April 30, 2020
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ayşen Canan Pakeloğlu

MSc Student

Halic University

Eligibility Criteria

Inclusion Criteria

  • Participants must be between the ages of 4 and
  • Participants must be classified as Level II, III, or IV according to the Gross Motor Function Classification System (GMFCS).

Exclusion Criteria

  • Participants who had previously received sensory integration therapy, - Undergone Botulinum Toxin-A injections, or surgical interventions in the past year.
  • Participants who were using pharmacological agents affecting muscle tone.
  • Participants with an uncontrolled history of epilepsy.
  • Participants who were unable to attend the study regularly.

Outcomes

Primary Outcomes

Gross Motor Function Measure-88 (GMFM-88)

Time Frame: 8 weeks

The evaluation is organized into sections based on different motor skills: Section A covers lying and rolling, Section B includes sitting, Section C focuses on crawling and kneeling, Section D assesses standing, and Section E includes walking, running, and jumping. Altogether, there are 88 items: Section A (17 items), Section B (20 items), Section C (14 items), Section D (13 items), and Section E (24 items). The minimum clinically important difference (MCID) ranges from 0.8 to 1.6 for a medium effect size and 1.3 to 2.6 for a larger effect size.

Secondary Outcomes

  • Trunk Control Measurement Scale (TCMS)(8 weeks)
  • Pediatric Balance Scale (PBS)(8 weeks)

Study Sites (1)

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