Cerebral Palsy (CP)NCT07000578
The Effect of Hip Joint Orthotic Intervention and Conventional Exercise Training on Spasticity, Balance and Walking Performance in Children With Cerebral Palsy
An observational study of Cerebral Palsy (CP), run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Cerebral palsy (SP) is defined as a group of persistent disorders that cause activity limitation of movement and postural development. Children with cerebral palsy are typically born with a normal anatomical hip sequence. The incidence of hip dysplasia reported in patients with cerebral palsy ranges from 2% to 75%. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Cerebral Palsy (CP)
- How many people
- 19 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 15 Dec 2025
- Phase
- Observational
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cerebral palsy
Who may be able to join
- 4 -16 age range
- Diagnosis of unilateral or bilateral spastic cerebral palsy
- With a tendency to increase in hip muscle imbalance or hip adduction
- At least 10 meters walkable (with independent or auxiliary device)
- GMFCS I- II- III level according to the gross motor function classification system
Who cannot join
- The presence of dysplasia of the hip
- Severe adductor spasticity, Modified Ashworth Scale ≥ 3
- Botulinum toxin injection into lower extremities in the last 6 months
- Use of drugs to reduce spasticity
- The presence of epilepsy
- Mental inadequacy at a level that cannot understand commands
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Medipol University
Istanbul, Beykoz, 34810
About this study
Official title: The Effect of Hip Joint Orthotic Intervention and Conventional Exercise Training on Spasticity, Balance and Walking Performance in Children With Cerebral Palsy: A Clinical Study
Cerebral palsy (SP) is defined as a group of persistent disorders that cause activity limitation of movement and postural development. Children with cerebral palsy are typically born with a normal anatomical hip sequence. The incidence of hip dysplasia reported in patients with cerebral palsy ranges from 2% to 75%. Various non-surgical measures have been used to prevent or slow the progression of spastic hip dysplasia. The therapy program should include activities designed to sustain hip movement and promote weight bearing. However, there is no convincing evidence that treatment alone prevents hip subluxation. To prevent the progression of hip dysplasia, the physical therapy program should include activities designed to increase the functionality of the buttocks and promote weight bearing. In our study, standing strategies will be applied as conventional therapy. Orthotizing, corrective dynamic elastomeric fabric orthoses and taping applications are often used to prevent hip dysplasia. In our study, TheraTogs orthotic garment part, auxiliary dynamic belt material supporting muscles Tog-Rite will be used.Tog-Rite with a width of 7 cm will be made by applying approximately 50-60% stretch with spiral winding from the hip to the bottom of the knee. Positioning will be taught to families and instructed to wear 4 hours a day. Reminders will be made via remote weekly message, families will be able to reach the therapist at any time. Conventional therapy will continue for 2 sessions per week, 45 minutes in a clinical setting. T0: initial assessment, T1: 3ay conventional therapy, T3: 3 months of conventional therapy + positioning with spasticity, balance and impact on walking will be examined. Socia-demographic information forms of the children taken to the study will be recorded. According to the Gross Motor Function Classification System, children of the GMFCS I- II- III level will be taken to work. Children's independence levels will be determined and recorded with the Functional Independence Measure (WeeFIM). Muscle tone will be assessed by the Modified Ashworth Scale. The Pediatric Berg Balance Scale will be applied for functional balance. Balance measurement will be done with the Becure Balance System. Assessment of the gait will be done through the Gillette functional assessment questionnaire. The walking speed will be done with a 10 meter walking test.
- Conditions
- Cerebral Palsy (CP)
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
Measured: From enrollment to the end of treatment at treatment in 0, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start15 Jun 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Medipol 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Demet Sarıyıldız, PhD(c), Medipol University
- Investigators
- Devrim Tarakcı, Assoc. Dr., Principal investigator, İstanbul Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000578
- Sponsor's protocol ID
- E-10840098-202.3.02-2974
- Status last verified
- Aug 2026
- First submitted
- 24 May 2025
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hip Joint Orthotic Intervention and Conventional Exercise Training on Spasticity, Balance and Walking Performance in Children With Cerebral Palsy: A Clinical Study
- ClinicalTrials.gov ID
- NCT07000578
- Acronym / sponsor ID
- E-10840098-202.3.02-2974
- Conditions
- Cerebral Palsy (CP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 3 Jun 2025 (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.
Cerebral palsy (SP) is defined as a group of persistent disorders that cause activity limitation of movement and postural development. Children with cerebral palsy are typically born with a normal anatomical hip sequence. The incidence of hip dysplasia reported in patients with cerebral palsy ranges from 2% to 75%. Various non-surgical measures have been used to prevent or slow the progression of spastic hip dysplasia. The therapy program should include activities designed to sustain hip movement and promote weight bearing. However, there is no convincing evidence that treatment alone prevents hip subluxation. To prevent the progression of hip dysplasia, the physical therapy program should include activities designed to increase the functionality of the buttocks and promote weight bearing. In our study, standing strategies will be applied as conventional therapy. Orthotizing, corrective dynamic elastomeric fabric orthoses and taping applications are often used to prevent hip dysplasia. In our study, TheraTogs orthotic garment part, auxiliary dynamic belt material supporting muscles Tog-Rite will be used.Tog-Rite with a width of 7 cm will be made by applying approximately 50-60% stretch with spiral winding from the hip to the bottom of the knee. Positioning will be taught to families and instructed to wear 4 hours a day. Reminders will be made via remote weekly message, families will be able to reach the therapist at any time. Conventional therapy will continue for 2 sessions per week, 45 minutes in a clinical setting. T0: initial assessment, T1: 3ay conventional therapy, T3: 3 months of conventional therapy + positioning with spasticity, balance and impact on walking will be examined. Socia-demographic information forms of the children taken to the study will be recorded. According to the Gross Motor Function Classification System, children of the GMFCS I- II- III level will be taken to work. Children's independence levels will be determined and recorded with the Functional Independence Measure (WeeFIM). Muscle tone will be assessed by the Modified Ashworth Scale. The Pediatric Berg Balance Scale will be applied for functional balance. Balance measurement will be done with the Becure Balance System. Assessment of the gait will be done through the Gillette functional assessment questionnaire. The walking speed will be done with a 10 meter walking test.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cerebral palsy
Key inclusion criteria (5 listed)
- 4 -16 age range
- Diagnosis of unilateral or bilateral spastic cerebral palsy
- With a tendency to increase in hip muscle imbalance or hip adduction
- At least 10 meters walkable (with independent or auxiliary device)
- GMFCS I- II- III level according to the gross motor function classification system
Key exclusion criteria (6 listed)
- The presence of dysplasia of the hip
- Severe adductor spasticity, Modified Ashworth Scale ≥ 3
- Botulinum toxin injection into lower extremities in the last 6 months
- Use of drugs to reduce spasticity
- The presence of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Ashworth Scale
Time frame: From enrollment to the end of treatment at treatment in 0, 3 months and 6 months
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 7 Oct 2026.
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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.
Devrim Tarakcı, Assoc. Dr. principal investigator
İstanbul Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy (CP), run by Medipol 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 5 inclusion and 6 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 7 Oct 2026. 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?
Modified Ashworth Scale (time frame: From enrollment to the end of treatment at treatment in 0, 3 months and 6 months). 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 7 Oct 2026.