Sensory Integration Therapy and Cerebral Palsy

Sponsor

Kirsehir Ahi Evran Universitesi (Other)

Overall Status

Completed

CT.gov ID

NCT05966428

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy	Other: Conventional Exercises Other: Sensory Integration Therapy	N/A

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

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The study consisted of 2 groups as control and experiment.The study consisted of 2 groups as control and experiment.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control Group Conventional Exercises	Other: Conventional Exercises 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.
Experimental: Intervention Group Conventional Exercises + Sensory Integration Therapy	Other: Conventional Exercises 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. Other: Sensory Integration Therapy 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.

Arm

Intervention/Treatment

Active Comparator: Control Group

Conventional Exercises

Other: Conventional Exercises

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.

Experimental: Intervention Group

Conventional Exercises + Sensory Integration Therapy

Other: Conventional Exercises

Other: Sensory Integration Therapy

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.

Outcome Measures

Primary Outcome Measures

Muscle Tone [A day before the rehabilitation]
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 [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 [A day before the rehabilitation]
Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )
Functional Balance [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 [A day before the rehabilitation]
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 [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 [A day before the rehabilitation]
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 [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 Outcome Measures

Gross Motor Function Classification [A day before the rehabilitation]
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 [8 week]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Atahan TURHAN	Kirsehir	Merkez	Turkey	40100

Sponsors and Collaborators

Kirsehir Ahi Evran Universitesi

Investigators

Principal Investigator: Atahan TURHAN, PhD, Kirsehir Ahi Evran University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Atahan TURHAN, Principal Investigator: Atahan Turhan, PhD, Kirsehir Ahi Evran Universitesi

ClinicalTrials.gov Identifier:

NCT05966428

Other Study ID Numbers:

KAEU-T.ATAHAN-001

First Posted:

Jul 28, 2023

Last Update Posted:

Jul 28, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Atahan TURHAN, Principal Investigator: Atahan Turhan, PhD, Kirsehir Ahi Evran Universitesi

Sensory Integration

Physical Therapy and Rehabilitation

Additional relevant MeSH terms:

Cerebral Palsy

Study Results

No Results Posted as of Jul 28, 2023