Effect of Sensory Integration in Diplegic Cerebral Palsy

NCT06462859 | Completed

• 1 other identifier: HalicU-FTR-ACP-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Diplegic Cerebral Palsy

Keywords

Cerebral Palsy; Diplegia Type; Treatment; Balance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pediatric Balance Scale (PBS)

  8 weeks

• Trunk Control Measurement Scale (TCMS)

  8 weeks

Study Arms (2)

The experimental group

EXPERIMENTAL

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; Other: Neurodevelopmental Treatment Group

Control Group

OTHER

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

Interventions

Sensory Integration Therapy Group 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).

The experimental group

Neurodevelopmental Treatment Group 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 experimental group

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Halic University: lead

Study Sites (1)

Ziya Special Education and Rehabilitation Center

Istanbul, Kagıthane, 34408, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ayşen Canan Pakeloğlu, MSc

  Halic University

  PRINCIPAL INVESTIGATOR

• Seda Saka, Asst. Prof.

  Halic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Information regarding the allocation of each group was not provided and outcome assessment was performed by an investigator blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student

Model Details: Two groups with a neurodevelopmental treatment control group

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 17, 2024
• Study Start: January 1, 2020
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: June 17, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)