Sensory Integration Therapy and Cerebral Palsy

NCT05966428 | Completed

• 1 other identifier: KAEU-T.ATAHAN-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Cerebral Palsy

Keywords

Sensory Integration; Physical Therapy and Rehabilitation

Outcome Measures

Primary Outcomes (8)

• Muscle Tone

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

  A day before the rehabilitation

• Muscle Tone

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

  8 week

• Functional Balance

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

  A day before the rehabilitation

• Functional Balance

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

  8 week

• Gross Motor Function

  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".)

  A day before the rehabilitation

• Gross Motor Function

  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".)

  8 week

• Functional Independence

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

  A day before the rehabilitation

• Functional Independence

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

  8 week

Secondary Outcomes (2)

• Gross Motor Function Classification

  A day before the rehabilitation

• Gross Motor Function Classification

  8 week

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Conventional Exercises

Other: Conventional Exercises

Intervention Group

EXPERIMENTAL

Conventional Exercises + Sensory Integration Therapy

Other: Conventional Exercises; Other: Sensory Integration Therapy

Interventions

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.

Control Group; Intervention 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.

Intervention Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (1)

Atahan TURHAN

Kırşehir, Merkez, 40100, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 35455527 RESULT

• 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.

  PMID: 36439588 RESULT

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Atahan TURHAN, PhD

  Kirsehir Ahi Evran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator: Atahan Turhan, PhD

Model Details: The study consisted of 2 groups as control and experiment.

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 28, 2023
• Study Start: January 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)