Clinical trial NCT06462859: Effect of Sensory Integration in Diplegic Cerebral Palsy
Official title: Effect of Sensory Integration on Motor Function, Balance, and Trunk Control in Diplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diplegic Cerebral Palsy
Keywords: Cerebral Palsy
Diplegia Type
Treatment
Balance
Lead sponsor: Halic University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups with a neurodevelopmental treatment control group
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gross Motor Function Measure-88 (GMFM-88)
timeFrame: 8 weeks
Secondary outcomes:
measure: Pediatric Balance Scale (PBS)
timeFrame: 8 weeks
measure: Trunk Control Measurement Scale (TCMS)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ziya Special Education and Rehabilitation Center
state: Kagıthane
Study officials:
affiliation: Halic University
name: Ayşen Canan Pakeloğlu, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Halic University
name: Seda Saka, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References: