"Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy

Recruiting now

Conditions studied: Diplegic Cerebral Palsy

In brief

" 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."

Key facts

Study ID

NCT06343688

Run by

Abant Izzet Baysal University

People needed

38

Starts

2024-04-01

Expected to finish

2025-12-01

Last updated by the study team

2025-02-06

Who can join

Age: 4 and older, up to 15. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 may not qualify if…

• 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 is running

• Bolu Abant Izzet Baysal University — Bolu, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

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