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
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.
- 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