Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy on Proprioceptive Sense and Balance.

Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy

This is a non-invasive prospective study investigating the effects of balance discs with different surfaces used in balance education in children with cerebral palsy on proprioceptive sense and balance.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: Pediatric neurodevelopmental therapy; Other: smooth balance disc; Other: Spiky balance disc

Detailed Description

Many methods are used for balance training. One of them is balance discs. Balance discs consist of smooth and rough surfaces. Balance training is given to children with cerebral palsy on these two surfaces. Thanks to its balance disc structure, it plays an active role in the development of balance, but there is a need for evidence about whether rough or smooth surfaces and training have superiority over each other. Knowing the difference between the two surfaces will help the staff about which surface to use in the treatment and will be beneficial for the children.

The aim of this study is to determine whether there is a difference between a rough and smooth surface in terms of improving proprioceptive sense and balance.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: İlkan Çiçek; Phone Number: +90 55481456; Email: ilkancicek97@gmail.com

Study Locations

• Turkey
  • Hatay
    • Antakya, Hatay, Turkey, 31000
      • Recruiting
      • Hatay Mustafa Kemal Üniversitesi
      • Sub-Investigator: Yılmaz Akbaş, doctoral lecturer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with cerebral palsy
• Diagnosed with motor developmental delay
• 0-12 years old
• Levels 1 and 2 according to GMFCS
• Having bilateral and unilaterally affected spastic type CP
• Cooperate with assessments

Exclusion Criteria:

• Botulinum toxin administration in the last 6 months
• Having had any surgical operation in the last 6 months
• Having dyskinetic, ataxic and hypotonic type CP
• Unable to cooperate with assessments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spiky balance disc study group; Bobath therapy will be studied with the children in this group and balance training will be given on the rough (spiky) surface of the extra balance disc.	Other: Pediatric neurodevelopmental therapy; Bobath therapy; Other: smooth balance disc; Balance discs consist of smooth and rough surface. Balance training is given to children with cerebral palsy on these two surfaces. Thanks to its balance disc structure, it plays an active role in the development of balance.
Experimental: Smooth balance disc study group; Bobath therapy will be studied with the children in this group and balance training will be given on the smooth (flat) surface of the extra balance disc.	Other: Pediatric neurodevelopmental therapy; Bobath therapy; Other: Spiky balance disc; Balance discs consist of smooth and rough surface. Balance training is given to children with cerebral palsy on these two surfaces. Thanks to its balance disc structure, it plays an active role in the development of balance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pediatric Berg balance test:	The Pediatric Berg Balance Test is a modified version of the Berg Balance Test used to assess functional balance skills in school-aged children.Patients are evaluated out of 56 points, with the highest score being 56. Change will be evaluated	baseline and week 10
Change in Functional reach test	The Functional Reach Test is a clinical outcome measurement and assessment tool to detect dynamic balance in a single simple task. While standing, it measures the distance between the length of an extended arm at maximum forward reach while maintaining a stable base of support.Change will be evaluated.	baseline and week 10
Change in One-leg standing test	The one-leg stance test is a test in which the time to stand on balance is measured on the right and left extremities of the patient, and evaluates the static balance. Change will be evaluated.	baseline and week 10
Change in Proprioceptive sensory test:	Active and passive repositioning test will be used to evaluate ankle proprioceptive sensation. Passive repositioning: The person to be tested is asked to learn that position by positioning the joint at a certain angle. Then, while the joint is moved passively, the person is asked to stop the movement when it reaches the previously learned position. The numerical difference between the angle found by the person and the angle taught before is evaluated. Active repositioning: The person is asked to find the position taught to the person by moving their extremity, and the numerical difference is determined.Change will be evaluated.	baseline and week 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
height	Children's height will be measured in cm with a tape measure.	baseline
weight	Their weight will be measured with precision scales and indicated in kg.	baseline
body mass index	Body mass index will be stated as kilo/meter*2.	baseline

Collaborators and Investigators

• Sponsor: Mustafa Kemal University

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Anticipated): January 9, 2023
• Study Completion (Anticipated): January 15, 2023

Study Registration Dates

• First Submitted: January 3, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 9, 2023

Study Record Updates

• Last Update Posted (Estimate): January 11, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: PTIlkan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No