Cerebral PalsyNCT05676983
Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy on Proprioceptive Sense and Balance.
A study testing Spiky balance disc, Pediatric neurodevelopmental therapy and smooth balance disc in people with Cerebral Palsy, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Spiky balance disc, Pediatric neurodevelopmental therapy and smooth balance disc
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2022to 15 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Hatay Mustafa Kemal Üniversitesi
Antakya, Hatay, 31000
Yılmaz Akbaş, doctoral lecturer
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Spiky balance disc, Pediatric neurodevelopmental therapy, smooth balance disc
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiky balance discOther
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 therapyOther
Bobath therapy
smooth balance discOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pediatric neurodevelopmental therapy; Other: 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. Receives: Other: Spiky balance disc; Other: Pediatric neurodevelopmental therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline and week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start5 Dec 2022
- Primary completion9 Jan 2023 (estimated)
- Study completion15 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlkan Cicek, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676983
- Sponsor's protocol ID
- PTIlkan
- Status last verified
- Jan 2023
- First submitted
- 3 Jan 2023
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41485031
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Balance Discs With Different Surfaces Used in Balance Education in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05676983
- Acronym / sponsor ID
- PTIlkan
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 9 Jan 2023 (estimated)
- Study completion
- 15 Jan 2023 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spiky balance disc study group | Experimental | Other: Pediatric neurodevelopmental therapy, Other: smooth balance discBobath 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. |
| Smooth balance disc study group | Experimental | Other: Spiky balance disc, Other: Pediatric neurodevelopmental therapyBobath 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. |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiky balance discBalance 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. | Other | Smooth balance disc study group |
| Pediatric neurodevelopmental therapyBobath therapy | Other | Smooth balance disc study group, Spiky balance disc study group |
| smooth balance discBalance 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. | Other | Spiky balance disc study group |
Primary outcome
Change in Pediatric Berg balance test:
Time frame: baseline and week 10
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
Time frame: baseline and week 10
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
Time frame: baseline and week 10
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:
Time frame: baseline and week 10
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Derived from this study: PubMed 41485031Bezgin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spiky balance disc, Pediatric neurodevelopmental therapy and smooth balance disc in people with Cerebral Palsy, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact İlkan Çiçek (+90 55481456, ilkancicek97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pediatric Berg balance test: (time frame: baseline and week 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05676983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.