Sensory Integration Therapy and Cerebral Palsy

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

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

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Conventional Exercises; Other: Sensory Integration Therapy

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Kirsehir, Merkez, Turkey, 40100
      • Atahan Turhan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	A day before the rehabilitation
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)	8 week
Functional Balance	Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )	A day before the rehabilitation
Functional Balance	Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)	8 week
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".)	A day before the rehabilitation
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".)	8 week
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)	A day before the rehabilitation
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)	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	A day before the rehabilitation
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)	8 week

Collaborators and Investigators

• Sponsor: Kirsehir Ahi Evran Universitesi
• Investigators: Principal Investigator: Atahan TURHAN, PhD, Kirsehir Ahi Evran University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 21, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Sensory Integration; Physical Therapy and Rehabilitation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: KAEU-T.ATAHAN-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No