Effect of Sensory Integration in Diplegic Cerebral Palsy

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

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

Study Overview

• Status: Completed
• Conditions: Diplegic Cerebral Palsy
• Intervention / Treatment: Other: Sensory Integration Therapy Group; Other: Neurodevelopmental Treatment Group

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kagıthane
    • Istanbul, Kagıthane, Turkey, 34408
      • Ziya Special Education and Rehabilitation Center

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants must be between the ages of 4 and 17.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The experimental group; The experimental group received sensory integration therapy in addition to the NDT program.Both groups participated in NDT sessions for 45 minutes, three times a week, over a span of 8 weeks.	Other: Sensory Integration Therapy Group; The experimental group received sensory integration therapy in addition to the NDT program. The NDT program is customized for each child, featuring a unique blend of static and dynamic balance exercises, coordination exercises, mobility exercises, and strength training exercises. Participants attended 45-minute NDT and sensory integration sessions three times a week for 8 weeks. Sensory integration therapy, visual perception activities (block design, shape recognition in pictures, puzzles, matching geometric shapes and letters, numbers and classification exercises), body awareness activities (showing body parts, drawing life-size drawings, turning left and right, recognizing body parts by touching ), tactile perception exercises (feeling and touching various textures and shapes) and visual-motor coordination training (eye tracking exercises, activities with moving objects and panel activities).; Other: Neurodevelopmental Treatment Group; The NDT program is customized for each child, featuring a mix of static and dynamic balance exercises, coordination exercises, mobility exercises, and strength training exercises. He attended 45-minute NDT sessions three times a week for 8 weeks. There is no treatment or medication other than NDT.
Other: Control Group; The NDT program was customized for each child, incorporating a unique blend of static and dynamic balance exercises, coordination exercises, mobility exercises, and strength training exercises.Both groups participated in NDT sessions for 45 minutes, three times a week, over a span of 8 weeks.	Other: Neurodevelopmental Treatment Group; The NDT program is customized for each child, featuring a mix of static and dynamic balance exercises, coordination exercises, mobility exercises, and strength training exercises. He attended 45-minute NDT sessions three times a week for 8 weeks. There is no treatment or medication other than NDT.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gross Motor Function Measure-88 (GMFM-88)	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Balance Scale (PBS)	The PBS includes 14 items designed to assess daily life activities and functional skills. Each section is scored from 0 to 4, with a maximum total score of 56. A higher score indicates better functional balance performance.	8 weeks
Trunk Control Measurement Scale (TCMS)	This assessment includes 15 items where children follow commands to perform movements within specific subsections, with their performance scored accordingly. The total score ranges from 0 to 58, with higher scores denoting better trunk control. The items gauge gross motor functions by assessing the child's performance. Each section is rated on a 4-point Likert scale, and percentages are calculated for each section. The final score is obtained by summing these percentages and dividing by 5.	8 weeks

Collaborators and Investigators

• Sponsor: Halic University
• Investigators: Principal Investigator: Ayşen Canan Pakeloğlu, MSc, Halic University; Principal Investigator: Seda Saka, Asst. Prof., Halic University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: June 14, 2024
• First Posted (Actual): June 17, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Treatment; Cerebral Palsy; Balance; Diplegia Type
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: HalicU-FTR-ACP-01

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