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Clinical Trials/NCT05966428
NCT05966428CompletedNot Applicable

The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy

Kirsehir Ahi Evran Universitesi2 sites in 1 country24 target enrollmentStarted: January 1, 2018Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
24
Locations
2
Primary Endpoint
Muscle Tone

Study Overview

Brief Summary

This intervention study was planned to investigate the effects of Sensory Integration Therapy that added to the conventional therapy program on spasticity, balance, motor function and functional independency levels of children with spastic diplegic cerebral palsy

Detailed Description

Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a non-progressive lesion in the brain that has not yet completed its development. Cerebral palsy is among the most common causes of disability in childhood. There are many conditions that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous system in patients with Cerebral Palsy causes some problems in the musculoskeletal system, nervous system and sensory systems. In addition to these problems, depending on the level of the lesion, posture, movement disorders and balance problems occur in individuals with Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving, interpreting and organizing our senses for an effective integration of the individual with the environment. When the literature is examined, the number of studies investigating the effect of sensory integration program in children with spastic diplegic type Cerebral Palsy is insufficient. The aim of this study is to investigate the effect of sensory integration therapy on spasticity, balance and motor function in children with spastic diplegic type Cerebral Palsy and to provide the data obtained at the end of the study to the literature both theoretically and practically.

The hypothesis of the study is:

  • Sensory integration program reduces spasticity in children with spastic diplegic type Cerebral Palsy.
  • Sensory integration program increases balance in children with spastic diplegic type Cerebral Palsy.
  • Sensory integration program increases motor function in children with spastic diplegic type Cerebral Palsy.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
4 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Between the ages of 4-17
  • Diagnosed with spastic diplegic type Cerebral Palsy
  • Having Gross Motor Function Classification System levels I and II

Exclusion Criteria

  • Children who underwent phenol and botulinum toxin-a injections in the last 6 months before the study
  • Had a previous surgical operation, and had a cardiopulmonary disease that could prevent exercise
  • Children with communication, hearing and vision problems

Outcomes

Primary Outcomes

Muscle Tone

Time Frame: 8 week

Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)

Functional Balance

Time Frame: 8 week

Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)

Gross Motor Function

Time Frame: 8 week

Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)

Functional Independence

Time Frame: 8 week

Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)

Secondary Outcomes

  • Gross Motor Function Classification(8 week)

Investigators

Sponsor
Kirsehir Ahi Evran Universitesi
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Atahan TURHAN

Principal Investigator: Atahan Turhan, PhD

Kirsehir Ahi Evran Universitesi

Study Sites (2)

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