Spastic Cerebral PalsyNCT07122362
Effect of Elastic Lower Extremity Orthosis on Gait and Balance in Children With Spastic Cerebral Palsy
A study testing Elastic Lower Extremity Orthosis and Neurodevelopmental Therapy in people with Spastic Cerebral Palsy, run by Gazi University at 2 sites in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of an elastic lower extremity orthosis on gait and balance in children with spastic cerebral palsy who present with an in-toeing gait pattern. The study compares conventional neurodevelopmental therapy alone to therapy combined with the orthosis. Read more about this study
- Who is it for?
- Ages 18 to 84 months
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Elastic Lower Extremity Orthosis and Neurodevelopmental Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 25 Aug 2025to 1 Nov 2025
- 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 18 to 84 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Voluntary participation
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) level 1, 2, or 3
- Age between 18 and 84 months
- Presence of in-toeing gait pattern
Who cannot join
- GMFCS level 4 or 5
- Botulinum toxin injection or surgical intervention targeting the lower extremities or pelvis within the last 6 months
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Turkey
Ankara, Ankara, 06000
Niğde Ömer Halisdemir University Bor Physical Therapy and Rehabilitation Training and Research Hospital
Niğde, Niğde Province, 51000
About this study
Official title: Investigation of the Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effect of an elastic lower extremity orthosis on gait and balance in children with spastic cerebral palsy who present with an in-toeing gait pattern. The study compares conventional neurodevelopmental therapy alone to therapy combined with the orthosis.
Read the detailed description
Cerebral palsy (CP) is a group of permanent disorders affecting movement and posture and is one of the most common causes of motor disability in children. One of the most frequent rotational gait abnormalities in children with spastic CP is in-toeing, which may result from increased femoral anteversion, internal tibial torsion, or foot deformities such as metatarsus varus or metatarsus adductus.
Elastic orthoses wrapped around the femoral region can generate active rotational forces and help modify the foot progression angle during gait. In early childhood, elastic external rotation straps starting from the foot can also be used for tibial rotation problems.
This randomized controlled trial will compare the effects of conventional neurodevelopmental therapy alone with therapy combined with the use of an elastic lower extremity orthosis.
Primary outcome measure: Gait parameters
Secondary outcome measure: Balance parameters
The study hypothesizes that the group receiving the orthosis in addition to conventional therapy will demonstrate superior outcomes in terms of gait and balance compared to the control group.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Elastic Lower Extremity Orthosis, Neurodevelopmental Therapy
- Keywords
- cerebral palsy, in-toeing gait, balance, orthoses, neoprene
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastic Lower Extremity OrthosisDevice
Participants in the intervention group receive conventional neurodevelopmental therapy combined with an elastic lower extremity orthosis designed to correct internal rotation deformities and improve gait and balance in children with spastic cerebral palsy. The orthosis applies elastic tension around the femoral region and tibia to target rotational problems.
Neurodevelopmental TherapyBehavioural
Participants receive conventional neurodevelopmental therapy only.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Neurodevelopmental Therapy | Active comparator | Participants receive conventional neurodevelopmental therapy only. Receives: Behavioral: Neurodevelopmental Therapy |
| Intervention Group: Therapy + Elastic Orthosis | Experimental | Participants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis. Receives: Device: Elastic Lower Extremity Orthosis; Behavioral: Neurodevelopmental Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameters assessed by Edinburgh Visual Gait Analysis
The Edinburgh Visual Gait Analysis Scale will be used to assess changes in gait patterns before and after the intervention. This scale consists of 17 items. Each item is scored between 0 and 2. A total score closer to zero indicates improved gait. The Edinburgh Visual Gait Analysis Scale was developed to quantitatively analyze gait parameters at different stages in recorded videos. During the assessment, children will be videotaped walking on a flat surface with their lower extremities bare. These recordings will assess each lower extremity during the stance and swing phases of gait.
Measured: Baseline and 8 weeks after intervention
Secondary outcomes (1)
Balance parameters assessed by Pediatric Balance Scale
The Pediatric Balance Scale will be used to assess balance performance and changes in balance ability at baseline and 8 weeks after the intervention. The 14-item Pediatric Balance Scale is a functional balance measurement tool adapted for the pediatric population and allows for the assessment of balance in various positions and during movement; each item is scored from 0 to 4, with the highest possible score being 56. A higher score indicates better balance.
Measured: Baseline and 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start25 Aug 2025
- Primary completion20 Oct 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halime ERKAN, Gazi University
- Investigators
- BÜLENT ELBASAN, Prof., Study chair, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Türkiye
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122362
- Sponsor's protocol ID
- 2024 - 587
- Status last verified
- Aug 2025
- First submitted
- 30 Jul 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) will be made available upon reasonable request from qualified researchers with ethics approval, starting 6 months after study completion. Data sharing will be conducted under a data sharing agreement to ensure participant confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Elastic Lower Extremity Orthosis on Gait and Balance Parameters in Children With Spastic Cerebral Palsy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07122362
- Acronym / sponsor ID
- 2024 - 587
- Conditions
- Spastic Cerebral Palsy
- Keywords
- cerebral palsy, in-toeing gait, balance, orthoses, neoprene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Aug 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 14 Aug 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.
This randomized controlled trial aims to evaluate the effect of an elastic lower extremity orthosis on gait and balance in children with spastic cerebral palsy who present with an in-toeing gait pattern. The study compares conventional neurodevelopmental therapy alone to therapy combined with the orthosis.
Detailed description
Cerebral palsy (CP) is a group of permanent disorders affecting movement and posture and is one of the most common causes of motor disability in children. One of the most frequent rotational gait abnormalities in children with spastic CP is in-toeing, which may result from increased femoral anteversion, internal tibial torsion, or foot deformities such as metatarsus varus or metatarsus adductus.
Elastic orthoses wrapped around the femoral region can generate active rotational forces and help modify the foot progression angle during gait. In early childhood, elastic external rotation straps starting from the foot can also be used for tibial rotation problems.
This randomized controlled trial will compare the effects of conventional neurodevelopmental therapy alone with therapy combined with the use of an elastic lower extremity orthosis.
Primary outcome measure: Gait parameters
Secondary outcome measure: Balance parameters
The study hypothesizes that the group receiving the orthosis in addition to conventional therapy will demonstrate superior outcomes in terms of gait and balance compared to the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group: Neurodevelopmental Therapy | Active comparator | Behavioral: Neurodevelopmental TherapyParticipants receive conventional neurodevelopmental therapy only. |
| Intervention Group: Therapy + Elastic Orthosis | Experimental | Device: Elastic Lower Extremity Orthosis, Behavioral: Neurodevelopmental TherapyParticipants receive conventional neurodevelopmental therapy plus elastic lower extremity orthosis. |
Who may qualify
- Ages
- 18 to 84 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Voluntary participation
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) level 1, 2, or 3
- Age between 18 and 84 months
- Presence of in-toeing gait pattern
Key exclusion criteria (2 listed)
- GMFCS level 4 or 5
- Botulinum toxin injection or surgical intervention targeting the lower extremities or pelvis within 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 |
|---|---|---|
| Elastic Lower Extremity OrthosisParticipants in the intervention group receive conventional neurodevelopmental therapy combined with an elastic lower extremity orthosis designed to correct internal rotation deformities and improve gait and balance in children with spastic cerebral palsy. The orthosis applies elastic tension around the femoral region and tibia to target rotational problems. | Device | Intervention Group: Therapy + Elastic Orthosis |
| Neurodevelopmental TherapyParticipants receive conventional neurodevelopmental therapy only. | Behavioural | Control Group: Neurodevelopmental Therapy, Intervention Group: Therapy + Elastic Orthosis |
Primary outcome
Gait parameters assessed by Edinburgh Visual Gait Analysis
Time frame: Baseline and 8 weeks after intervention
The Edinburgh Visual Gait Analysis Scale will be used to assess changes in gait patterns before and after the intervention. This scale consists of 17 items. Each item is scored between 0 and 2. A total score closer to zero indicates improved gait. The Edinburgh Visual Gait Analysis Scale was developed to quantitatively analyze gait parameters at different stages in recorded videos. During the assessment, children will be videotaped walking on a flat surface with their lower extremities bare. These recordings will assess each lower extremity during the stance and swing phases of gait.
1 secondary outcome
Balance parameters assessed by Pediatric Balance Scale
Time frame: Baseline and 8 weeks after intervention
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 6 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) will be made available upon reasonable request from qualified researchers with ethics approval, starting 6 months after study completion. Data sharing will be conducted under a data sharing agreement to ensure participant confidentiality.
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Peripheral Neurotomies of the Upper Limb in Children With Cerebral Palsy.
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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.
BÜLENT ELBASAN, Prof. study chair
Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University, Ankara, Türkiye
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elastic Lower Extremity Orthosis and Neurodevelopmental Therapy in people with Spastic Cerebral Palsy, run by Gazi University at 2 sites 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 2 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Gait parameters assessed by Edinburgh Visual Gait Analysis (time frame: Baseline and 8 weeks after intervention). 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 6 Jan 2026.