Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352151
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-02
Brief Title:
Effects of Orofacial Therapy and Therapeutic Yoga in Children With Down Syndrome
Sponsor:
Hasan Kalyoncu University
Organization:
Hasan Kalyoncu University
Study Overview
Official Title:
Comparison of the Effects of Orofacial Therapy and Therapeutic Yoga on Swallowing Sleeping Habits and Quality of Life in Children With Down Syndrome
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The study aims to compare the effects of orofacial therapy and therapeutic yoga on swallowing sleep habits and quality of life in children with Down syndrome
Detailed Description:
At special education and rehabilitation centers children diagnosed with Down syndrome will undergo initial assessment and those meeting the inclusion criteria will be included in the study following parental voluntary consent
Measurement assessments will be conducted three times before therapy after therapy at week 8 and at a follow-up at week 12 To ensure a fair and unbiased distribution children participating in the study will be randomly assigned to their respective groups using a sealed envelope method a widely accepted and transparent randomization technique
1 Grup Routine Physiotherapy PT Group - Receiving routine physiotherapy treatment
Children who receive routine physiotherapy treatment in special education centers will be evaluated at the end of the 8th session following the treatment After 12 weeks the control will be in the form of an evaluation
2 Grup Orofacial Therapy Routine PT Group - Receiving orofacial therapy and routine physiotherapy treatment
For the orofacial therapy sessions will be held twice a week for eight weeks with each session lasting 30-45 minutes totaling 16 sessions This structured and intensive therapy schedule is designed to provide a comprehensive evaluation of the therapys effectiveness Secondary evaluations will be conducted following the 8th treatment session and a follow-up evaluation will be performed after 12 weeks
3 Grup Therapeutic Yoga Group Routine PT Group - Receiving therapeutic yoga and routine physiotherapy treatments
The therapeutic yoga group at special education centers will also meet twice weekly for eight weeks each lasting 30-45 minutes for 16 sessions Secondary evaluations will be conducted following the 8th treatment session and a follow-up evaluation will be performed after 12 weeks
Measurement assessments will be conducted three times before therapy after therapy at week 8 and at a follow-up at week 12 To ensure a fair and unbiased distribution children participating in the study will be randomly assigned to their respective groups using a sealed envelope method a widely accepted and transparent randomization technique
1 Grup Routine Physiotherapy PT Group - Receiving routine physiotherapy treatment
Children who receive routine physiotherapy treatment in special education centers will be evaluated at the end of the 8th session following the treatment After 12 weeks the control will be in the form of an evaluation
2 Grup Orofacial Therapy Routine PT Group - Receiving orofacial therapy and routine physiotherapy treatment
For the orofacial therapy sessions will be held twice a week for eight weeks with each session lasting 30-45 minutes totaling 16 sessions This structured and intensive therapy schedule is designed to provide a comprehensive evaluation of the therapys effectiveness Secondary evaluations will be conducted following the 8th treatment session and a follow-up evaluation will be performed after 12 weeks
3 Grup Therapeutic Yoga Group Routine PT Group - Receiving therapeutic yoga and routine physiotherapy treatments
The therapeutic yoga group at special education centers will also meet twice weekly for eight weeks each lasting 30-45 minutes for 16 sessions Secondary evaluations will be conducted following the 8th treatment session and a follow-up evaluation will be performed after 12 weeks
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