Clinical trial NCT05966428: Sensory Integration Therapy and Cerebral Palsy
Official title: The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Sensory Integration
Physical Therapy and Rehabilitation
Lead sponsor: Kirsehir Ahi Evran Universitesi
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 24
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study consisted of 2 groups as control and experiment.
Primary purpose: TREATMENT

Brief summary: This intervention study was planned to investigate the effects of Sensory Integration Therapy that added to the conventional therapy program on spasticity, balance, motor function and functional independency levels of children with spastic diplegic cerebral palsy

Detailed description: Cerebral Palsy is a disease that can cause motor skill and posture disorders due to a non-progressive lesion in the brain that has not yet completed its development. Cerebral palsy is among the most common causes of disability in childhood. There are many conditions that can cause Cerebral Palsy. Risk groups that cause brain damage can be considered as prenatal, perinatal and postnatal risk factors.The lesion that occurs in the central nervous system in patients with Cerebral Palsy causes some problems in the musculoskeletal system, nervous system and sensory systems. In addition to these problems, depending on the level of the lesion, posture, movement disorders and balance problems occur in individuals with Cerebral Palsy. Sensory integration therapy is a neurological process of perceiving, interpreting and organizing our senses for an effective integration of the individual with the environment. When the literature is examined, the number of studies investigating the effect of sensory integration program in children with spastic diplegic type Cerebral Palsy is insufficient. The aim of this study is to investigate the effect of sensory integration therapy on spasticity, balance and motor function in children with spastic diplegic type Cerebral Palsy and to provide the data obtained at the end of the study to the literature both theoretically and practically.

The hypothesis of the study is:

* Sensory integration program reduces spasticity in children with spastic diplegic type Cerebral Palsy.
* Sensory integration program increases balance in children with spastic diplegic type Cerebral Palsy.
* Sensory integration program increases motor function in children with spastic diplegic type Cerebral Palsy.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 4-17
* Diagnosed with spastic diplegic type Cerebral Palsy
* Having Gross Motor Function Classification System levels I and II

Exclusion Criteria:

* Children who underwent phenol and botulinum toxin-a injections in the last 6 months before the study
* Had a previous surgical operation, and had a cardiopulmonary disease that could prevent exercise
* Children with communication, hearing and vision problems

Primary outcomes:
measure: Muscle Tone
timeFrame: A day before the rehabilitation
measure: Muscle Tone
timeFrame: 8 week
measure: Functional Balance
timeFrame: A day before the rehabilitation
measure: Functional Balance
timeFrame: 8 week
measure: Gross Motor Function
timeFrame: A day before the rehabilitation
measure: Gross Motor Function
timeFrame: 8 week
measure: Functional Independence
timeFrame: A day before the rehabilitation
measure: Functional Independence
timeFrame: 8 week
Secondary outcomes:
measure: Gross Motor Function Classification
timeFrame: A day before the rehabilitation
measure: Gross Motor Function Classification
timeFrame: 8 week
Other outcomes:
Locations:
city: Kirsehir
country: Turkey
facility: Atahan TURHAN
state: Merkez
Study officials:
affiliation: Kirsehir Ahi Evran University
name: Atahan TURHAN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kantor J, Hlavackova L, Du J, Dvorakova P, Svobodova Z, Karasova K, Kantorova L. The Effects of Ayres Sensory Integration and Related Sensory Based Interventions in Children with Cerebral Palsy: A Scoping Review. Children (Basel). 2022 Apr 1;9(4):483. doi: 10.3390/children9040483.
citation: Warutkar VB, Krishna Kovela R. Review of Sensory Integration Therapy for Children With Cerebral Palsy. Cureus. 2022 Oct 26;14(10):e30714. doi: 10.7759/cureus.30714. eCollection 2022 Oct.