Effect of Sensory Integration in Diplegic Cerebral Palsy

Diplegic Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06462859
• Other study ID #: HalicU-FTR-ACP-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: June 2024
• Source: Halic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Diplegic Cerebral Palsy
• Paralysis

Intervention

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).
• 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.

Locations

Country	Name	City	State
Turkey	Ziya Special Education and Rehabilitation Center	Istanbul	Kagithane

Sponsors (1)

Lead Sponsor	Collaborator
Halic University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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