Effect of Sensory Integration in Diplegic Cerebral Palsy

NCT ID: NCT06462859

Last Updated: 2024-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-04-30

Brief Summary

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

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.

Conditions

Diplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sensory Integration Therapy Group

Intervention Type: OTHER

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).

Neurodevelopmental Treatment Group

Intervention Type: OTHER

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.

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.

Group Type: OTHER

Neurodevelopmental Treatment Group

Intervention Type: OTHER

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Halic University

OTHER

Sponsor Role: lead

Responsible Party

Ayşen Canan Pakeloğlu

MSc Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayşen Canan Pakeloğlu, MSc

Role: PRINCIPAL_INVESTIGATOR

Halic University

Seda Saka, Asst. Prof.

Role: PRINCIPAL_INVESTIGATOR

Halic University

Locations

Ziya Special Education and Rehabilitation Center

Istanbul, Kagıthane, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HalicU-FTR-ACP-01

Identifier Type: -

Identifier Source: org_study_id