Cerebral PalsyNCT06747078
Comparison of Three Treatment in Children With Cerebral Palsy
A study testing Neurodevelopmental Therapy (NDT) + Core Stabilization Training, Neurodevelopmental therapy + Balance Exercises and Neurodevelopmental therapy in people with Cerebral Palsy, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
In this study, considering the importance of walking and balance functions in improving the quality of life and achieving independence in children with cerebral palsy, it was aimed to examine whether core stabilization exercises specifically designed for children with cerebral palsy have an impact on improving balance… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Neurodevelopmental Therapy (NDT) + Core Stabilization Training, Neurodevelopmental therapy + Balance Exercises and Neurodevelopmental therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2021to 16 Dec 2024
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cases between the ages of 7-18
- Cases with GMFCS level I and II
- Cases diagnosed with hemiparetic and diparetic CP
Who cannot join
- Cases with levels III, IV and V according to GMFCS
- Having an intellectual disability that would prevent participation in assessment and exercise training
- Having had Botulinum Toxin (BOTOX) Type A application within the last 6 months
- Having undergone any surgical operation within the last 6 months
- Hearing and vision problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A
Denizli, Kınıklı, 20070
About this study
Official title: The Effect of Core and Balance Exercises on Gait, Balance and Quality Of Life in Children With Cerebral Palsy: A Comparative Study
In this study, considering the importance of walking and balance functions in improving the quality of life and achieving independence in children with cerebral palsy, it was aimed to examine whether core stabilization exercises specifically designed for children with cerebral palsy have an impact on improving balance and walking functions as well as quality of life. Additionally, the study sought to determine whether this approach has superiority over conventional balance exercises.
Read the detailed description
Children with cerebral palsy included in the study were randomized into three groups using block randomization based on age, type of cerebral palsy and the Gross Motor Function Classification System (GMFCS). Children with cerebral palsy aged 7-18 years were included. Group 1 (study group, n=12) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group, n=12) received NDT combined with balance exercises (BE). The control group (n=12) received only NDT. Treatments were conducted for 60 minutes per session, three times a week, over 8 weeks, for a total of 24 sessions, with an equal duration across groups. Participants' balance was evaluated using the Pediatric Balance Scale (PBS) and the SportKat 550® device. The Trunk Involvement Scale (TIS) was used to measure trunk impairment, the Six-Minute Walk Test (6MWT) to assess functional mobility and walking capacity and the Pediatric Outcome Data Collection Instrument (PODCI) to evaluate quality of life. All assessments were performed by the same physiotherapist before and after treatment
- Conditions
- Cerebral Palsy
- Being tested
- Neurodevelopmental Therapy (NDT) + Core Stabilization Training, Neurodevelopmental therapy + Balance Exercises, Neurodevelopmental therapy
- Keywords
- balance, Cerebral Palsy, Core Stabilization Exercise, Neurodevelopmental Therapy, Quality of life
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental Therapy (NDT) + Core Stabilization TrainingOther
Also called NDT+CSE
In addition to the neurodevelopmental treatment of 30 minutes per day, 3 sessions per week, and a total of 24 sessions, core stabilization training was applied 3 sessions per week for 8 weeks and a total of 24 sessions. The core stabilization training session lasted 30 minutes.
Neurodevelopmental therapy + Balance ExercisesOther
Also called NDT+BE
In addition to NDT, which is 30 minutes per day, 3 sessions per week and 24 sessions in total, balance training was applied 3 sessions per week for 8 weeks and 24 sessions in total. The balance exercise session lasted 30 minutes.
Neurodevelopmental therapyOther
NDT was applied for 60 minutes per day, 3 sessions per week, for 8 weeks and a total of 24 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (study group): Neurodevelopmental therapy (NDT) combined with core stabilization exercises ( | Active comparator | In addition to neurodevelopmental treatment, which is 30 minutes per day, 3 sessions per week and 24 sessions in total, core stabilization training was applied 3 sessions per week for 8 weeks and 24 sessions in total. The core stabilization training session lasted 30 minutes. Receives: Other: Neurodevelopmental Therapy (NDT) + Core Stabilization Training |
| Group 2 (study group) neurodevelopmental treatment combined with balance exercises | Active comparator | In addition to the neurodevelopmental treatment of 30 minutes per day, 3 sessions per week, and a total of 24 sessions, balance training was applied 3 sessions per week for 8 weeks and a total of 24 sessions. The balance training session lasted 30 minutes. Receives: Other: Neurodevelopmental therapy + Balance Exercises |
| Group 3: Neurodevelopmental treatment control group | Active comparator | Only neurodevelopmental treatment was applied for 60 minutes per day, 3 sessions per week, for 8 weeks, for a total of 24 sessions. Receives: Other: Neurodevelopmental therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Balance Scale (PBS)
The Pediatric Balance Scale is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: eight weeks
SportKat550 Kinesthetic Ability Trainer (SportKAT 550)
The SportKAT-550® device used to determine postural sway consists of sensors that detect sway and is also a balance platform. There is a digital screen in front of the platform to provide feedback to the person on it. The person on the platform is asked to hold the "X" mark on the digital screen in the center while the static balance test is performed. A score of 500 or lower than 500 in the static balance measurement indicates that the balance is good and the postural sway is low.For dynamic balance, a score between 750-950 is excellent, and a score between 1350-1550 indicates good balance.
Measured: eight weeks
Pediatric Outcome Data Collection Instrument (PODCI)
It is a widely used scale to determine quality of life, functional health status and participation in children with cerebral palsy.The test is a Likert type scale and consists of 5 parts.PVTA, which has validity and reliability in Turkish, is scored between 0-100.
Measured: eight weeks
Secondary outcomes (2)
Six Minute Walk Test (6MWT)
The 6-minute walking test (6 MWT) is an easy test that is frequently used to determine functional mobility and walking distance in children with cerebral palsy. In our study, 6MWT was performed by measuring the distance the subject walked quickly but without running on a straight distance of 20 meters.
Measured: eight weeks
The Trunk Involvement Scale (TIS)
The Trunk Involvement Scale was used to assess the trunk. It consists of three subsections: dynamic, static and coordination. Scoring can vary between 0-23.
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start25 Aug 2021
- Primary completion16 Dec 2024
- Study completion16 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were divided into 3 groups. Group 1 (study group) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group) received NDT combined with balance exercises (BE). The control group received only NDT
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hatice Özoymak Akçin, Pamukkale University
- Investigators
- Nılufer CETISLI-KORKMAZ, PT.PhD.Prof, Study director, Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747078
- Sponsor's protocol ID
- PAU-FTR-HÖA-01
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Core and Balance Exercises on Gait, Balance and Quality Of Life in Children With Cerebral Palsy: A Comparative Study
- ClinicalTrials.gov ID
- NCT06747078
- Acronym / sponsor ID
- PAU-FTR-HÖA-01
- Conditions
- Cerebral Palsy
- Keywords
- balance, Cerebral Palsy, Core Stabilization Exercise, Neurodevelopmental Therapy, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 24 Dec 2024 (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.
In this study, considering the importance of walking and balance functions in improving the quality of life and achieving independence in children with cerebral palsy, it was aimed to examine whether core stabilization exercises specifically designed for children with cerebral palsy have an impact on improving balance and walking functions as well as quality of life. Additionally, the study sought to determine whether this approach has superiority over conventional balance exercises.
Detailed description
Children with cerebral palsy included in the study were randomized into three groups using block randomization based on age, type of cerebral palsy and the Gross Motor Function Classification System (GMFCS). Children with cerebral palsy aged 7-18 years were included. Group 1 (study group, n=12) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group, n=12) received NDT combined with balance exercises (BE). The control group (n=12) received only NDT. Treatments were conducted for 60 minutes per session, three times a week, over 8 weeks, for a total of 24 sessions, with an equal duration across groups. Participants' balance was evaluated using the Pediatric Balance Scale (PBS) and the SportKat 550® device. The Trunk Involvement Scale (TIS) was used to measure trunk impairment, the Six-Minute Walk Test (6MWT) to assess functional mobility and walking capacity and the Pediatric Outcome Data Collection Instrument (PODCI) to evaluate quality of life. All assessments were performed by the same physiotherapist before and after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were divided into 3 groups. Group 1 (study group) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group) received NDT combined with balance exercises (BE). The control group received only NDT
| Arm | Type | Receives |
|---|---|---|
| Group 1 (study group): Neurodevelopmental therapy (NDT) combined with core stabilization exercises ( | Active comparator | Other: Neurodevelopmental Therapy (NDT) + Core Stabilization TrainingIn addition to neurodevelopmental treatment, which is 30 minutes per day, 3 sessions per week and 24 sessions in total, core stabilization training was applied 3 sessions per week for 8 weeks and 24 sessions in total. The core stabilization training session lasted 30 minutes. |
| Group 2 (study group) neurodevelopmental treatment combined with balance exercises | Active comparator | Other: Neurodevelopmental therapy + Balance ExercisesIn addition to the neurodevelopmental treatment of 30 minutes per day, 3 sessions per week, and a total of 24 sessions, balance training was applied 3 sessions per week for 8 weeks and a total of 24 sessions. The balance training session lasted 30 minutes. |
| Group 3: Neurodevelopmental treatment control group | Active comparator | Other: Neurodevelopmental therapyOnly neurodevelopmental treatment was applied for 60 minutes per day, 3 sessions per week, for 8 weeks, for a total of 24 sessions. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Cases between the ages of 7-18
- Cases with GMFCS level I and II
- Cases diagnosed with hemiparetic and diparetic CP
Key exclusion criteria (5 listed)
- Cases with levels III, IV and V according to GMFCS
- Having an intellectual disability that would prevent participation in assessment and exercise training
- Having had Botulinum Toxin (BOTOX) Type A application within the last 6 months
- Having undergone any surgical operation within the last 6 months
- Hearing and vision problems
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 |
|---|---|---|
| Neurodevelopmental Therapy (NDT) + Core Stabilization TrainingAlso: NDT+CSEIn addition to the neurodevelopmental treatment of 30 minutes per day, 3 sessions per week, and a total of 24 sessions, core stabilization training was applied 3 sessions per week for 8 weeks and a total of 24 sessions. The core stabilization training session lasted 30 minutes. | Other | Group 1 (study group): Neurodevelopmental therapy (NDT) combined with core stabilization exercises ( |
| Neurodevelopmental therapy + Balance ExercisesAlso: NDT+BEIn addition to NDT, which is 30 minutes per day, 3 sessions per week and 24 sessions in total, balance training was applied 3 sessions per week for 8 weeks and 24 sessions in total. The balance exercise session lasted 30 minutes. | Other | Group 2 (study group) neurodevelopmental treatment combined with balance exercises |
| Neurodevelopmental therapyNDT was applied for 60 minutes per day, 3 sessions per week, for 8 weeks and a total of 24 sessions. | Other | Group 3: Neurodevelopmental treatment control group |
Primary outcome
Pediatric Balance Scale (PBS)
Time frame: eight weeks
The Pediatric Balance Scale is used to assess functional balance skills in children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
SportKat550 Kinesthetic Ability Trainer (SportKAT 550)
Time frame: eight weeks
The SportKAT-550® device used to determine postural sway consists of sensors that detect sway and is also a balance platform. There is a digital screen in front of the platform to provide feedback to the person on it. The person on the platform is asked to hold the "X" mark on the digital screen in the center while the static balance test is performed. A score of 500 or lower than 500 in the static balance measurement indicates that the balance is good and the postural sway is low.For dynamic balance, a score between 750-950 is excellent, and a score between 1350-1550 indicates good balance.
Pediatric Outcome Data Collection Instrument (PODCI)
Time frame: eight weeks
It is a widely used scale to determine quality of life, functional health status and participation in children with cerebral palsy.The test is a Likert type scale and consists of 5 parts.PVTA, which has validity and reliability in Turkish, is scored between 0-100.
2 secondary outcomes
Six Minute Walk Test (6MWT)
Time frame: eight weeks
The Trunk Involvement Scale (TIS)
Time frame: eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
Nılufer CETISLI-KORKMAZ, PT.PhD.Prof study director
Pamukkale University Faculty of Physiotherapy and Rehabilitation Block A
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Therapy (NDT) + Core Stabilization Training, Neurodevelopmental therapy + Balance Exercises and Neurodevelopmental therapy in people with Cerebral Palsy, run by Pamukkale 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Dec 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric Balance Scale (PBS) (time frame: eight weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.