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

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Spiky balance disc
Pediatric neurodevelopmental therapy
smooth balance disc
Sponsored by
Mustafa Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Palsy

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hatay Mustafa Kemal ÜniversitesiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Spiky balance disc study group

Smooth balance disc study group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
January 3, 2023
Last Updated
January 10, 2023
Sponsor
Mustafa Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT05676983
Brief Title
Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy on Proprioceptive Sense and Balance.
Official Title
Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
January 9, 2023 (Anticipated)
Study Completion Date
January 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spiky balance disc study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Smooth balance disc study group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spiky balance disc
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Pediatric neurodevelopmental therapy
Intervention Description
Bobath therapy
Intervention Type
Other
Intervention Name(s)
smooth balance disc
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pediatric Berg balance test:
Description
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
Time Frame
baseline and week 10
Title
Change in Functional reach test
Description
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.
Time Frame
baseline and week 10
Title
Change in One-leg standing test
Description
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.
Time Frame
baseline and week 10
Title
Change in Proprioceptive sensory test:
Description
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.
Time Frame
baseline and week 10
Other Pre-specified Outcome Measures:
Title
height
Description
Children's height will be measured in cm with a tape measure.
Time Frame
baseline
Title
weight
Description
Their weight will be measured with precision scales and indicated in kg.
Time Frame
baseline
Title
body mass index
Description
Body mass index will be stated as kilo/meter*2.
Time Frame
baseline

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
İlkan Çiçek
Phone
+90 55481456
Email
ilkancicek97@gmail.com
Facility Information:
Facility Name
Hatay Mustafa Kemal Üniversitesi
City
Antakya
State/Province
Hatay
ZIP/Postal Code
31000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yılmaz Akbaş, doctoral lecturer

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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