search
Back to results

Sensory Integration Therapy and Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Exercises
Sensory Integration Therapy
Sponsored by
Kirsehir Ahi Evran Universitesi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Sensory Integration, Physical Therapy and Rehabilitation

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Atahan TURHAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Intervention Group

Arm Description

Conventional Exercises

Conventional Exercises + Sensory Integration Therapy

Outcomes

Primary Outcome Measures

Muscle Tone
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Muscle Tone
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
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )
Functional Balance
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
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".)
Gross Motor Function
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
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
Functional Independence
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)

Secondary Outcome Measures

Gross Motor Function Classification
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
Gross Motor Function Classification
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)

Full Information

First Posted
July 13, 2023
Last Updated
July 21, 2023
Sponsor
Kirsehir Ahi Evran Universitesi
search

1. Study Identification

Unique Protocol Identification Number
NCT05966428
Brief Title
Sensory Integration Therapy and Cerebral Palsy
Official Title
The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran Universitesi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Sensory Integration, Physical Therapy and Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study consisted of 2 groups as control and experiment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional Exercises
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Conventional Exercises + Sensory Integration Therapy
Intervention Type
Other
Intervention Name(s)
Conventional Exercises
Intervention Description
This conventional exercises included stretching and strengthening, balance-coordination, mobility and range of motion exercises. The control group received conventional therapy 3 days a week for 8 weeks. Each therapy session a day lasted 45 minutes in control group.
Intervention Type
Other
Intervention Name(s)
Sensory Integration Therapy
Intervention Description
The Sensory Integration Therapy was applied to the intervention group in addition to the conventional exercise program. Sensory Integration Therapy included tactile, proprioceptive, and vestibular activities. The tactile sensory activities consisted of materials such as stepping stones, tactile box, brushing, fabric walking path. The vestibular sensory activities consisted of materials such as hammock swings, trampolines, rope nets, rock walls, river stones. Proprioceptive sensory activities consisted of materials such as weight bearing activities, heavy lifting, deep pressure, big ball activities, tug of war and ball pits. The intervention group underwent each session 45 minute conventional therapy and 15 minutes SIT. The therapy program continued 3 days a week for 8 weeks in intervention group.
Primary Outcome Measure Information:
Title
Muscle Tone
Description
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Time Frame
A day before the rehabilitation
Title
Muscle Tone
Description
Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)
Time Frame
8 week
Title
Functional Balance
Description
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )
Time Frame
A day before the rehabilitation
Title
Functional Balance
Description
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)
Time Frame
8 week
Title
Gross Motor Function
Description
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".)
Time Frame
A day before the rehabilitation
Title
Gross Motor Function
Description
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".)
Time Frame
8 week
Title
Functional Independence
Description
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
Time Frame
A day before the rehabilitation
Title
Functional Independence
Description
Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Gross Motor Function Classification
Description
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
Time Frame
A day before the rehabilitation
Title
Gross Motor Function Classification
Description
Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atahan TURHAN, PhD
Organizational Affiliation
Kirsehir Ahi Evran University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atahan TURHAN
City
Kirsehir
State/Province
Merkez
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35455527
Citation
Kantor J, Hlavackova L, Du J, Dvorakova P, Svobodova Z, Karasova K, Kantorova L. The Effects of Ayres Sensory Integration and Related Sensory Based Interventions in Children with Cerebral Palsy: A Scoping Review. Children (Basel). 2022 Apr 1;9(4):483. doi: 10.3390/children9040483.
Results Reference
result
PubMed Identifier
36439588
Citation
Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.
Results Reference
result

Learn more about this trial

Sensory Integration Therapy and Cerebral Palsy

We'll reach out to this number within 24 hrs