Actively Recruiting
Examination of the Instant Effect of DAFO Use on Balance and Lower Extremity Gross Motor Functions in Individuals With Spastic Diplegic Cerebral Palsy
Led by Abant Izzet Baysal University · Updated on 2025-02-06
38
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the immediate effects of using Dynamic Ankle-Foot Orthoses (DAFOs) on balance and gross motor functions in children with spastic diplegic cerebral palsy aged 4 to 15 years who have mild to moderate motor impairment (GMFCS levels 1 and 2). Diplegic cerebral palsy mainly affects the lower limbs, causing movement difficulties and abnormal gait patterns. The study plans to contribute valuable knowledge to cerebral palsy rehabilitation by evaluating motor skills and balance with and without DAFO use. Children participating in the study will be assessed using various classification systems for motor, communication, manual, and eating abilities. Their gross motor functions and balance will be measured using tests such as the Gross Motor Function Measure (GMFM-88), Pediatric Berg Balance Scale, functional reach test, and Wii Balance Board. The evaluations will occur both while wearing custom-made DAFOs and barefoot, comparing the immediate impact of the orthoses. Participants will have their age, height, and weight recorded along with assessments like the GMFCS, MACS, CFCS, and EDACS. The study uses standardized balance and motor function tests on day 1 to measure outcomes. Data analysis will be performed by a blinded statistician using appropriate statistical methods. The study is observational and will include children and their families who agree to participate at a specialized rehabilitation center, with all assessments completed during the study period.
CONDITIONS
Brief Title
"Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Experienced lower extremity fractures or muscle-tendon and bone surgery in the past 6 months
- Undergone spinal or orthopedic surgery affecting the lower extremities
- Exposure to any pharmacological agent or intervention inhibiting spasticity in the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo evaluation of balance and lower extremity gross motor functions with and without the use of Dynamic Ankle-Foot Orthoses (DAFO).
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Bolu Abant Izzet Baysal University
Bolu, Turkey (Türkiye)
Actively Recruiting
Research Team
S
Seda Ayaz Taş, Asst. prof.
T
Tamer Çankaya, Asst. prof.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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