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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 15
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Turkey
Bolu Abant Izzet Baysal University
RECRUITING
Bolu
Contact Information
Primary
Seda Ayaz Taş, Asst. prof.
seda.ayaztas@ibu.edu.tr
5495458040
Backup
Tamer Çankaya, Asst. prof.
tamercankaya@gmail.com
5335519171
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 38
Treatments
Case Group
The Gross Motor Function Classification System (GMFCS) will be used to classify children's gross motor levels, 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. Additionally, the Gross Motor Function Measure (GMFM-88) items D and E will be used to assess 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 evaluated in two different ways: with and without DAFO.
Related Therapeutic Areas
Sponsors
Leads: Abant Izzet Baysal University

This content was sourced from clinicaltrials.gov