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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05676983
Other study ID # PTIlkan
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 5, 2022
Est. completion date January 15, 2023

Study information

Verified date January 2023
Source Mustafa Kemal University
Contact Ilkan Çiçek
Phone +90 55481456
Email ilkancicek97@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date January 15, 2023
Est. primary completion date January 9, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Pediatric neurodevelopmental therapy
Bobath therapy
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.

Locations

Country Name City State
Turkey Hatay Mustafa Kemal Üniversitesi Antakya Hatay

Sponsors (1)

Lead Sponsor Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

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