Effect of DAFO on balance and motor function in children with diplegic cerebral palsy
Examination of the Instant Effect of DAFO Use on Balance and Lower Extremity Gross Motor Functions in Individuals With Spastic Diplegic Cerebral Palsy
Abant Izzet Baysal University · NCT06343688
This study is testing how wearing a special ankle-foot brace can help improve balance and movement in children with diplegic cerebral palsy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 4 Years to 15 Years |
| Sex | All |
| Sponsor | Abant Izzet Baysal University (other) |
| Locations | 1 site (Bolu) |
| Trial ID | NCT06343688 on ClinicalTrials.gov |
What this trial studies
This study investigates how the use of Dynamic Ankle-Foot Orthosis (DAFO) affects balance and gross motor functions in children aged 4 to 15 with spastic diplegic cerebral palsy. Participants will be evaluated using various classification systems to assess their motor and communication abilities. The study aims to gather demographic data and measure the immediate effects of DAFO on the children's mobility and functional capabilities. Conducted at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center, the study will include children who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are children aged 4 to 15 diagnosed with spastic diplegic cerebral palsy who are using bilateral DAFO and have GMFCS levels 1 or 2.
Not a fit: Patients who have had recent lower extremity fractures or surgeries, or those using medications that inhibit spasticity, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance mobility and quality of life for children with diplegic cerebral palsy through improved balance and motor function.
How similar studies have performed: While there have been studies on the use of orthoses in cerebral palsy, the specific focus on DAFO's immediate effects in this population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosed with Spastic Diplegic type of cerebral palsy * Age between 4 and 15 years * Using bilateral Dynamic Ankle-Foot Orthosis (DAFO) * Communication Function Classification System (CFCS) level between 1 and 2 * Gross Motor Function Classification System (GMFCS) level between 1 and 2 * Willingness to participate in the study Exclusion Criteria: * Having experienced lower extremity fractures or muscle-tendon and bone surgery in the past 6 months, or having undergone spinal or orthopedic surgery affecting the lower extremities * Exposure to any pharmacological agent or intervention inhibiting spasticity in the past 6 months.
Where this trial is running
Bolu
- Bolu Abant Izzet Baysal University — Bolu, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: özge karanlık — Abant Izzet Baysal University
- Study coordinator: Seda Ayaz Taş, Asst. prof.
- Email: seda.ayaztas@ibu.edu.tr
- Phone: 5495458040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diplegic Cerebral Palsy, cerebral palsy, Diplegia, Spastic, orthosis, balance