Actively Recruiting
"Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy
Led by Abant Izzet Baysal University · Updated on 2025-02-06
38
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
" Study will investigate the immediate effect of DAFO usage on balance and gross motor functions in individuals with spastic diplegic cerebral palsy. The study is planned to be conducted with children aged 4-15 who have GMFCS levels 1 and 2 and who are willing to participate along with their families at the Turkey Spastic Children Foundation Metin Sabancı Special Education and Rehabilitation Center. During the dates of the study, children who meet the inclusion criteria will be evaluated. Demographic information such as age, height, and weight will be obtained for the participating children. To classify the gross motor levels of the children, the Gross Motor Function Classification System (GMFCS), the Manual Abilities Classification System (MACS) for hand skills, the Communication Function Classification System (CFCS) for communication skills, and the Eating and Drinking Ability Classification System (EDACS) for feeding skills will be used. In addition, the Gross Motor Function Measure (GMFM-88) items D and E for assessing motor skills, the Wii Balance Board for testing balance, the Pediatric Berg Balance Scale, and the functional reach test will be utilized. The balance and gross motor functions of the included children will be assessed in two different ways: with and without DAFO. Data analysis will be conducted by a blinded statistician who is not part of the research team. IBM SPSS 26 (Statistical Package for Social Sciences) will be used for statistical analysis of the data. Normality of continuous variables will be assessed using the Kolmogorov-Smirnov test. If continuous variables follow a normal (parametric) distribution, paired sample t-tests will be conducted on pre-test and post-test data. If the data are non-parametric, Wilcoxon test will be used. Pearson chi-square test or Spearman correlation coefficient will be used to determine the relationship between variables based on assumptions. Results will be evaluated at a significance level of p \< 0.05 with a 95% confidence interval."
CONDITIONS
Official 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 cerebral palsy
- Age between 4 and 15 years
- Using bilateral Dynamic Ankle-Foot Orthoses (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...
- History of lower extremity fractures or muscle-tendon and bone surgery within the past 6 months
- History of spinal or orthopedic surgery affecting lower extremities
- Use of any medication or intervention inhibiting spasticity in the past 6 months
AI-Screening
AI-Powered Screening
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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.
CONTACT
T
Tamer Çankaya, Asst. prof.
CONTACT
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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