NCT06343688 "Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy
| NCT ID | NCT06343688 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abant Izzet Baysal University |
| Condition | Diplegic Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 38 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 38 participants in total. It began in 2024-04-01 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
" 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."
Eligibility 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.
Contact & Investigator
özge karanlık
PRINCIPAL INVESTIGATOR
Abant Izzet Baysal University
Frequently Asked Questions
Who can join the NCT06343688 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 15 Years, studying Diplegic Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06343688 currently recruiting?
Yes, NCT06343688 is actively recruiting participants. Contact the research team at seda.ayaztas@ibu.edu.tr for enrollment information.
Where is the NCT06343688 trial being conducted?
This trial is being conducted at Bolu, Turkey (Türkiye).
Who is sponsoring the NCT06343688 clinical trial?
NCT06343688 is sponsored by Abant Izzet Baysal University. The principal investigator is özge karanlık at Abant Izzet Baysal University. The trial plans to enroll 38 participants.
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