Clinical trial Recruiting at 1 site Observational Ages 4 to 15

Effect of DAFO on balance and motor function in children with diplegic cerebral palsy

Official title: Examination of the Instant Effect of DAFO Use on Balance and Lower Extremity Gross Motor Functions in Individuals With Spastic Diplegic Cerebral Palsy

Run by Abant Izzet Baysal University · NCT06343688 · Data updated 2026-11-12

This study is testing how wearing a special ankle-foot brace can help improve balance and movement in children with diplegic cerebral palsy.

More Spastic Diplegic Cerebral Palsy trials

Quick facts

Study typeObservational
Ages4 Years to 15 Years
SexAll
Enrollment38 (estimated)
SponsorAbant Izzet Baysal University
Academic / other
Locations1 site (Bolu)
StatusRecruiting
StartedApril 1, 2024
Main results expectedApril 1, 2025
Study endsDecember 1, 2025
Registry record updatedFebruary 6, 2025
Trial IDNCT06343688 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.