Cerebral Palsy, SpasticNCT05956444
NDT on Fall Risk in Cerebral Palsied Children
A study testing Neurodevelopmental Therapy (NDT) and Conventional Physiotherapy in people with Cerebral Palsy, Spastic and Falling, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Children with spastic cerebral palsy experience falls due to weakness in balance skills and abnormalities in gait parameters. It is necessary to improve the quality of life of these children by reducing the frequency of falling. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Falling
- What is being tested?
- Neurodevelopmental Therapy (NDT) and Conventional Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 1 Oct 2022
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cerebral Palsy diagnosis
- Spastic type
- Gross Motor Function Classification System Level I and II
Who cannot join
- Tendon release surgery or Botox application in the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neurodevelopmental Treatment on Fall Risk and Balance in Children With Spastic Cerebral Palsy
Children with spastic cerebral palsy experience falls due to weakness in balance skills and abnormalities in gait parameters. It is necessary to improve the quality of life of these children by reducing the frequency of falling. Aim of this study was to investigate the effect of Neurodevelopmental Treatment on the risk of falling and balance and to contribute to the literature on this subject. Cases were randomized into study and control groups. At the beginning of the study, the balance skills of all the cases with spastic cerebral palsy were measured with the Pediatric Balance Scale, and the gait parameters and fall risks were measured with the LEGSys Temporospatial Gait Analysis Device. Then, an 8-week, case-specific, neurodevelopmental therapy program with intensive gait and balance training was applied to the study group in a 45-minute single session, 2 days a week. The control group received 8 weeks of conventional physiotherapy. At the end of the treatment process, the evaluations were repeated with the same methods.
- Conditions
- Cerebral Palsy, Spastic, Falling
- Being tested
- Neurodevelopmental Therapy (NDT), Conventional Physiotherapy
- 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)Other
In the treatment program; vestibular and proprioceptive training on the balance board; dynamic balance training in sitting with eyes open and closed, kneeling upright and standing; balance exercises in front of the mirror; standing on one leg with eyes open and closed to increase proprioceptive input; vestibular and proprioceptive training on exercise balls of the appropriate size; balance training on the trampoline; footpad sensory stimulation with different materials; weight-bearing training in sitting, crawling, kneeling and standing positions; functional reaching and throwing-holding exercises in different positions; multitasking pieces of training; gait exercises in various ways and training for climbing and descending stairs appropriate to the child's situation (assisted, unaided, symmetrical, reciprocal) took place.
Conventional PhysiotherapyOther
Classical physiotherapy applications for balance.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Treated with both the treatment programs determined on the basis of the NDT and conventional physiotherapy. Programs prepared specifically for each child, in a 45-minute single session, 2 days a week, for 8 weeks in total. Each child was given a treatment program tailored to their needs. Receives: Other: Neurodevelopmental Therapy (NDT); Other: Conventional Physiotherapy |
| Control Group | Active comparator | Treated with only the treatment programs determined on the basis of conventional physiotherapy. Receives: Other: Conventional Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
LEGSys, Temporospatial Gait Analysis Device
Determining the patient's risk of falling by performing a kinetic analysis of the gait
Measured: Beginning of the study
LEGSys, Temporospatial Gait Analysis Device
Determining the patient's risk of falling by performing a kinetic analysis of the gait
Measured: 8 weeks
Pediatric Balance Scale (PBS)
Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.
Measured: Beginning of the study
Pediatric Balance Scale (PBS)
Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Jun 2022
- Primary completion1 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy, SpasticStudies 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Tekin, Pamukkale University
- Investigators
- Fatih Tekin, Prof., Study chair, Faculty Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956444
- Sponsor's protocol ID
- FallRisk
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neurodevelopmental Treatment on Fall Risk and Balance in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05956444
- Acronym / sponsor ID
- FallRisk
- Conditions
- Cerebral Palsy, Spastic, Falling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 21 Jul 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.
Children with spastic cerebral palsy experience falls due to weakness in balance skills and abnormalities in gait parameters. It is necessary to improve the quality of life of these children by reducing the frequency of falling. Aim of this study was to investigate the effect of Neurodevelopmental Treatment on the risk of falling and balance and to contribute to the literature on this subject. Cases were randomized into study and control groups. At the beginning of the study, the balance skills of all the cases with spastic cerebral palsy were measured with the Pediatric Balance Scale, and the gait parameters and fall risks were measured with the LEGSys Temporospatial Gait Analysis Device. Then, an 8-week, case-specific, neurodevelopmental therapy program with intensive gait and balance training was applied to the study group in a 45-minute single session, 2 days a week. The control group received 8 weeks of conventional physiotherapy. At the end of the treatment process, the evaluations were repeated with the same methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Neurodevelopmental Therapy (NDT), Other: Conventional PhysiotherapyTreated with both the treatment programs determined on the basis of the NDT and conventional physiotherapy. Programs prepared specifically for each child, in a 45-minute single session, 2 days a week, for 8 weeks in total. Each child was given a treatment program tailored to their needs. |
| Control Group | Active comparator | Other: Conventional PhysiotherapyTreated with only the treatment programs determined on the basis of conventional physiotherapy. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Cerebral Palsy diagnosis
- Spastic type
- Gross Motor Function Classification System Level I and II
Key exclusion criteria (1 listed)
- Tendon release surgery or Botox application in the last 6 months
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)In the treatment program; vestibular and proprioceptive training on the balance board; dynamic balance training in sitting with eyes open and closed, kneeling upright and standing; balance exercises in front of the mirror; standing on one leg with eyes open and closed to increase proprioceptive input; vestibular and proprioceptive training on exercise balls of the appropriate size; balance training on the trampoline; footpad sensory stimulation with different materials; weight-bearing training in sitting, crawling, kneeling and standing positions; functional reaching and throwing-holding exercises in different positions; multitasking pieces of training; gait exercises in various ways and training for climbing and descending stairs appropriate to the child's situation (assisted, unaided, symmetrical, reciprocal) took place. | Other | Treatment Group |
| Conventional PhysiotherapyClassical physiotherapy applications for balance. | Other | Control Group, Treatment Group |
Primary outcome
LEGSys, Temporospatial Gait Analysis Device
Time frame: Beginning of the study
Determining the patient's risk of falling by performing a kinetic analysis of the gait
LEGSys, Temporospatial Gait Analysis Device
Time frame: 8 weeks
Determining the patient's risk of falling by performing a kinetic analysis of the gait
Pediatric Balance Scale (PBS)
Time frame: Beginning of the study
Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.
Pediatric Balance Scale (PBS)
Time frame: 8 weeks
Functional balance was assessed using PBS, which consists of fourteen tasks similar to activities of daily living. Higher scores indicate better balance.
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 21 Jul 2023.
Related trials for Cerebral Palsy, Spastic
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Not yet recruitingObservational study
Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
Cerebral Palsy Infantile, Upper Limb Spasticity
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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.
Fatih Tekin, Prof. study chair
Faculty Member
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) and Conventional Physiotherapy in people with Cerebral Palsy, Spastic and Falling, 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 1 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 21 Jul 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?
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?
LEGSys, Temporospatial Gait Analysis Device (time frame: Beginning of the study). 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?
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 21 Jul 2023.