Ignite Creation Date:
2024-07-17 @ 10:45 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461923
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-05-28
Brief Title:
Home-based Gait Rehabilitation Service Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Development and Feasibility Study of the Home-based Gait Rehabilitation Service by Using the Insole-type Gait Anaylsis Device for Children With Cerebral Palsy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Walking is a crucial daily activity that requires complex coordination of muscular systems It is essential for bone and muscle health cardiovascular fitness and activities of daily living making it an important indicator of prognosis and patient function Insole gait analysis devices are affordable and easy to use and they align well with standardized 3D gait analysis However their use outside of hospital settings is limited
This study aims to assess the usability and satisfaction of utilizing insole gait analysis devices for monitoring and providing feedback on the walking status of children with cerebral palsy exhibiting walking impairments in a home environment Additionally adherence to a home-based exercise program developed in this study will be evaluated
This study aims to assess the usability and satisfaction of utilizing insole gait analysis devices for monitoring and providing feedback on the walking status of children with cerebral palsy exhibiting walking impairments in a home environment Additionally adherence to a home-based exercise program developed in this study will be evaluated
Detailed Description:
The screening test is conducted after obtaining consent and it involves assessing whether the subject can independently walk more than 10 meters regardless of the use of assistive devices following an evaluation of their baseline symptoms and signs
Subjects who pass the screening test are provided with information about their current walking status and what constitutes normal walking Following the initial evaluation they are instructed to participate in the 6-week home exercise program and how to record an exercise log Additionally researchers provide participants with an insole gait analysis device and instruct them on its operation encouraging prolonged usage to ensure that usage time and walking patterns are recorded
Based on the collected measurement data feedback is provided over the phone at weeks 3 to 4 After completing the 6-week home exercise program a final evaluation is conducted in the same manner as the initial evaluation Satisfaction with the insole gait analysis device is assessed only at the time of the final evaluation
Usage and satisfaction with the insole gait analysis device will be analyzed and evaluation indicators will be compared before and after the home exercise program Additionally adherence to the home exercise program will be evaluated through exercise logs
Subjects who pass the screening test are provided with information about their current walking status and what constitutes normal walking Following the initial evaluation they are instructed to participate in the 6-week home exercise program and how to record an exercise log Additionally researchers provide participants with an insole gait analysis device and instruct them on its operation encouraging prolonged usage to ensure that usage time and walking patterns are recorded
Based on the collected measurement data feedback is provided over the phone at weeks 3 to 4 After completing the 6-week home exercise program a final evaluation is conducted in the same manner as the initial evaluation Satisfaction with the insole gait analysis device is assessed only at the time of the final evaluation
Usage and satisfaction with the insole gait analysis device will be analyzed and evaluation indicators will be compared before and after the home exercise program Additionally adherence to the home exercise program will be evaluated through exercise logs
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