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Completed

NCT Number: NCT05966428

Sensory Integration Therapy and Cerebral Palsy

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

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atahan TURHAN

Kırşehir, Merkez, 40100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional exercises

Other

This conventional exercises included stretching and strengthening, balance-coordination, mobility and range of motion exercises.

The control group received conventional therapy 3 days a week for 8 weeks. Each therapy session a day lasted 45 minutes in control group.

Sensory Integration Therapy

Other

The Sensory Integration Therapy was applied to the intervention group in addition to the conventional exercise program. Sensory Integration Therapy included tactile, proprioceptive, and vestibular activities. The tactile sensory activities consisted of materials such as stepping stones, tactile box, brushing, fabric walking path. The vestibular sensory activities consisted of materials such as hammock swings, trampolines, rope nets, rock walls, river stones. Proprioceptive sensory activities consisted of materials such as weight bearing activities, heavy lifting, deep pressure, big ball activities, tug of war and ball pits.

The intervention group underwent each session 45 minute conventional therapy and 15 minutes SIT. The therapy program continued 3 days a week for 8 weeks in intervention group.

Primary outcomes

  1. Muscle Tone

    Time frame: A day before the rehabilitation

    Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)

  2. Muscle Tone

    Time frame: 8 week

    Modified Ashworth Scale (The muscle tone evaluated on this scale is graded between 0 and 4 and is scored between 0 and 5)

  3. Functional Balance

    Time frame: A day before the rehabilitation

    Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function. )

  4. Functional Balance

    Time frame: 8 week

    Pediatric Berg Balance Scale (The scale consists of 14 section. Each section is scored from 0 lowest function to 4 highest function.)

  5. Gross Motor Function

    Time frame: A day before the rehabilitation

    Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)

  6. Gross Motor Function

    Time frame: 8 week

    Gross Motor Function Measure (The scores are in 4 categories as "0" not starting the activity, starting independently "1", partially completing "2" and independently completing "3".)

  7. Functional Independence

    Time frame: A day before the rehabilitation

    Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)

  8. Functional Independence

    Time frame: 8 week

    Functional Independence Measure for Children (These items are scored from 1 to 7 according to whether they received help while performing each function)

Secondary outcomes

  1. Gross Motor Function Classification

    Time frame: A day before the rehabilitation

    Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)

  2. Gross Motor Function Classification

    Time frame: 8 week

    Gross Motor Function Classification System (Children with Cerebral Palsy are classified in 5 levels (1-5) according to their motor skills, functional abilities, assistive technology and wheelchair requirements)

Sponsors and collaborators

Lead sponsor

Kirsehir Ahi Evran Universitesi

Other

Registry information

Official study title

The Affect of Sensory Integration Therapy and Conventional Exercise Therapy on Spasticity, Balance and Motor Function With Spastic Diplegic Cerebral Palsy

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 28, 2023
Registry last updated
Jul 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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