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Effect of Sensory Integration in Diplegic Cerebral Palsy

Not Applicable
Completed
Conditions
Diplegic Cerebral Palsy
Interventions
Other: Sensory Integration Therapy Group
Other: Neurodevelopmental Treatment Group
Registration Number
NCT06462859
Lead Sponsor
Halic University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
The experimental groupNeurodevelopmental Treatment GroupThe 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.
The experimental groupSensory Integration Therapy GroupThe 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.
Control GroupNeurodevelopmental Treatment GroupThe 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.
Primary Outcome Measures
NameTimeMethod
Gross Motor Function Measure-88 (GMFM-88)8 weeks

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.

Secondary Outcome Measures
NameTimeMethod
Trunk Control Measurement Scale (TCMS)8 weeks

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.

Pediatric Balance Scale (PBS)8 weeks

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.

Trial Locations

Locations (1)

Ziya Special Education and Rehabilitation Center

🇹🇷

Istanbul, Kagıthane, Turkey

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