NCT05676983

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 9, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 3, 2023

Last Update Submit

January 10, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • height

    baseline

  • weight

    baseline

  • body mass index

    baseline

Study Arms (2)

Spiky balance disc study group

EXPERIMENTAL

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 therapyOther: smooth balance disc

Smooth balance disc study group

EXPERIMENTAL

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: Spiky balance discOther: Pediatric neurodevelopmental therapy

Interventions

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.

Smooth balance disc study group

Bobath therapy

Smooth balance disc study groupSpiky balance disc study group

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.

Spiky balance disc study group

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal Üniversitesi

Antakya, Hatay, 31000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Bezgin S, Akkaya KU, Cicek I, Akbas Y, Elbasan B. Effects of balance training on different surfaces on ankle proprioception and functional balance in children with spastic cerebral palsy: a single-blind randomized controlled trial. BMC Pediatr. 2026 Jan 3;26(1):3. doi: 10.1186/s12887-025-06346-5.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate-physiotherapy graduate student

Study Record Dates

First Submitted

January 3, 2023

First Posted

January 9, 2023

Study Start

December 5, 2022

Primary Completion

January 9, 2023

Study Completion

January 15, 2023

Last Updated

January 11, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations