Home-based Gait Rehabilitation Service Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
NCT Number: NCT06461923
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Gait Disorders, Neurologic|Cerebral Palsy
Interventions: DEVICE: Insole wearing
Sponsor: Yonsei University
Collaborators: Korea Health Industry Development Institute
Sex: ALL
Age: CHILD, ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-06
Completion Date: 2025-06
Locations: Severance Hospital, Seoul, Seodaemun-gu, 03722, Korea, Republic of

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.

Primary Outcome Measures: 6-minute Walking Test, This test results will be assessed two times: baseline and after 6 weeks
Secondary Outcome Measures: Appendicular muscle mass (kg), This outcome will be measured using bioelectrical impedance., This test results will be assessed two times: baseline and after 6 weeks|Height (cm), This outcome will be measured using bioelectrical impedance., This test results will be assessed two times: baseline and after 6 weeks|Weight (kg), This outcome will be measured using bioelectrical impedance., This test results will be assessed two times: baseline and after 6 weeks|Grip Strength Test (kg), This test results will be assessed two times: baseline and after 6 weeks|The number of steps (n), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|Calories burned (kcal), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|Activity time (min), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|Activity distance (km), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|Walking speed (m/s), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|Stride length (cm), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|Left-right gait balance (%), This outcome will be collected using an insole-type gait analyzer., This test results will be assessed two times: baseline and after 6 weeks|10-meter Walking Test (m/s), This test results will be assessed two times: baseline and after 6 weeks|Pediatric Balance Scale (scores), The minimum score is 0 points, and the maximum score is 56 points. A higher score indicates better balance ability in children and a greater capacity to perform daily activities independently., This test results will be assessed two times: baseline and after 6 weeks|Gross Motor Function Classification System (levels), This test results will be assessed two times: baseline and after 6 weeks|Korean version of Cerebral Palsy Quality of Life (scores), If the participant is aged 8 or younger, the relevant questionnaire will be administered; otherwise, the Korean version of KIDSCREEN-52 will be used.

The minimum score is 0 points, and the maximum score is 100 points. A higher score indicates a higher quality of life., This test results will be assessed two times: baseline and after 6 weeks|Korean version of KIDSCREEN-52 (Children & Adolescents) (scores), If the participant is aged over 8, the relevant questionnaire will be administered.

The minimum score is 52 points, and the maximum score is 260 points. A higher score indicates a higher quality of life., This test results will be assessed two times: baseline and after 6 weeks|Korean version of KIDSCREEN-52 (Parents) (scores), The minimum score is 52 points, and the maximum score is 260 points. A higher score indicates a higher quality of life., This test results will be assessed two times: baseline and after 6 weeks|Satisfaction Survey for the Device (scores), The minimum score is 12, and the maximum score is 84 points. A higher score indicates lower satisfaction., This test results will be assessed once: after 6 weeks