Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343688
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-25
Brief Title:
Immediate Effect of DAFO on Gross Motor Function and Balance in Diplegic Cerebral Palsy
Sponsor:
Abant Izzet Baysal University
Organization:
Abant Izzet Baysal University
Study Overview
Official Title:
Examination of the Instant Effect of DAFO Use on Balance and Lower Extremity Gross Motor Functions in Individuals With Spastic Diplegic Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 005 with a 95 confidence interval
Detailed Description:
Cerebral Palsy CP is a group of motor disorders resulting from non-progressive damage to the immature brain leading to movement and posture impairments Approximately 2 to 3 out of every 1000 children worldwide are born with CP Prevalence studies conducted before 1990 reported an increasing trend in CP prevalence However prevalence is not static and improvements in prenatal care due to advancements in healthcare have led to a slight decrease in prevalence A study in 2013 reported a prevalence rate between 22 and 23
Children with CP exhibit various symptoms such as contractures spasticity and coordination disorders mainly affecting the musculoskeletal and nervous systems These symptoms adversely affect their mobility functional abilities and quality of life
CP is classified into three types based on movement disorder spastic dyskinetic and ataxic and into four classes based on the pattern of involvement quadriplegic hemiplegic diplegic and monoplegic Among these diplegic CP is the most common type accounting for 30-35 of cases Diplegic CP primarily affects the lower extremities more than the upper extremities Children with diplegic CP often exhibit a pathological gait characterized by pes equinovarus genu valgus excessive knee flexion increased hip adduction and internal rotation
The management of CP involves physiotherapy orthotic support surgeries temporary medical interventions and speech-language therapy Orthoses such as Ankle-Foot Orthoses AFOs are commonly used in CP rehabilitation Dynamic Ankle-Foot Orthoses DAFOs have emerged as a popular alternative to AFOs in diplegic CP DAFOs are designed to control muscle tone and prevent foot deformities by providing proper support to the foots plantar surface They allow for partial movement due to their flexible and thinner structure compared to rigid AFOs
Studies have shown that DAFOs significantly impact gross motor skills in children with CP DAFOs aim to manage foot deformities increase support facilitate skill training and improve mobility during standing and walking
1 Examine the effect of DAFO use on balance in children with diplegic CP
2 Investigate the effect of DAFO use on lower extremity gross motor functions in children with diplegic CP
3 Explore the impact of DAFO use on functionality in children with diplegic CP
Upon obtaining meaningful results this study aims to contribute to clinical practice and scientific research in the field of CP rehabilitation
Materials and Methods Design
Sample Size The sample size of this study was determined based on a power analysis conducted using data from a similar study With a significance level α of 005 power 1- β of 090 and effect size Cohens d of 097 it was calculated that a total of 38 patients would be sufficient to detect the difference However considering possible withdrawals or issues with completing the analysis the sample size was set at a minimum of 40
Procedure The study will be conducted with the participation of children aged 4-15 diagnosed with cerebral palsy CP at levels 1 and 2 according to the Gross Motor Function Classification System GMFCS at the Metin Sabancı Special Education and Rehabilitation Center for Children with Spastic Disabilities in Turkey The evaluation will take place among children who meet the predefined inclusion criteria during the specified dates
Demographic information such as age height and weight will be collected for the participating children Classification systems such as the Gross Motor Function Classification System GMFCS for assessing gross motor function the Manual Ability Classification System MACS for assessing manual abilities the Communication Function Classification System CFCS for assessing communication abilities and the Eating and Drinking Ability Classification System EDACS for assessing eating and drinking abilities will be used Additionally the Gross Motor Function Measure GMFM Pediatric Balance Scale PBS and functional reach test will be employed to evaluate motor skills and balance The childrens balance and gross motor functions will be assessed using different evaluation methods with and without the use of Dynamic Ankle Foot Orthoses DAFOs
Children with CP exhibit various symptoms such as contractures spasticity and coordination disorders mainly affecting the musculoskeletal and nervous systems These symptoms adversely affect their mobility functional abilities and quality of life
CP is classified into three types based on movement disorder spastic dyskinetic and ataxic and into four classes based on the pattern of involvement quadriplegic hemiplegic diplegic and monoplegic Among these diplegic CP is the most common type accounting for 30-35 of cases Diplegic CP primarily affects the lower extremities more than the upper extremities Children with diplegic CP often exhibit a pathological gait characterized by pes equinovarus genu valgus excessive knee flexion increased hip adduction and internal rotation
The management of CP involves physiotherapy orthotic support surgeries temporary medical interventions and speech-language therapy Orthoses such as Ankle-Foot Orthoses AFOs are commonly used in CP rehabilitation Dynamic Ankle-Foot Orthoses DAFOs have emerged as a popular alternative to AFOs in diplegic CP DAFOs are designed to control muscle tone and prevent foot deformities by providing proper support to the foots plantar surface They allow for partial movement due to their flexible and thinner structure compared to rigid AFOs
Studies have shown that DAFOs significantly impact gross motor skills in children with CP DAFOs aim to manage foot deformities increase support facilitate skill training and improve mobility during standing and walking
1 Examine the effect of DAFO use on balance in children with diplegic CP
2 Investigate the effect of DAFO use on lower extremity gross motor functions in children with diplegic CP
3 Explore the impact of DAFO use on functionality in children with diplegic CP
Upon obtaining meaningful results this study aims to contribute to clinical practice and scientific research in the field of CP rehabilitation
Materials and Methods Design
Sample Size The sample size of this study was determined based on a power analysis conducted using data from a similar study With a significance level α of 005 power 1- β of 090 and effect size Cohens d of 097 it was calculated that a total of 38 patients would be sufficient to detect the difference However considering possible withdrawals or issues with completing the analysis the sample size was set at a minimum of 40
Procedure The study will be conducted with the participation of children aged 4-15 diagnosed with cerebral palsy CP at levels 1 and 2 according to the Gross Motor Function Classification System GMFCS at the Metin Sabancı Special Education and Rehabilitation Center for Children with Spastic Disabilities in Turkey The evaluation will take place among children who meet the predefined inclusion criteria during the specified dates
Demographic information such as age height and weight will be collected for the participating children Classification systems such as the Gross Motor Function Classification System GMFCS for assessing gross motor function the Manual Ability Classification System MACS for assessing manual abilities the Communication Function Classification System CFCS for assessing communication abilities and the Eating and Drinking Ability Classification System EDACS for assessing eating and drinking abilities will be used Additionally the Gross Motor Function Measure GMFM Pediatric Balance Scale PBS and functional reach test will be employed to evaluate motor skills and balance The childrens balance and gross motor functions will be assessed using different evaluation methods with and without the use of Dynamic Ankle Foot Orthoses DAFOs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None