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Clinical Trials in South Korea / NCT06461923
Recruiting Not applicable

Home-based Gait Rehabilitation Service Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy

NCT06461923 · tracked via the Priya Life Science South Korea tracker
Sponsor
Yonsei University
Phase
Not applicable
Started
2024-08-01
Last updated
2025-02-10

Condition(s) studied

Gait Disorders, NeurologicCerebral Palsy

Investigational drug(s) / intervention(s)

Insole wearing

Insole wearing: The insole-wearing group is instructed to wear the insole gait analysis device as frequently and for as long as possible during outdoor activities. Participants receive feedback during 3rd to 4th week via telephone. Following a period of 6 weeks, an evaluation of the usability and satisfaction of the insole gait analysis device will be conducted.

Study 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.

Eligibility

Sex
ALL
Min age
7 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients diagnosed with cerebral palsy aged 7 to 18 years old 2. Patients classified as Gross Motor Function Classification System level 1 or 2 3. Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and submitted the informed consent form Exclusion Criteria: 1. Individuals with complications such as severe foot deformities where the sensors of the insole gait analysis device cannot be recognized 2. In addition to above, individuals with clinically significant findings deemed inappropriate for this study by the study director or person in charge based on medical judgment

Primary outcome measure(s)

  • 6-minute Walking Test — This test results will be assessed two times: baseline and after 6 weeks

Trial sites (1)

FacilityCityRegionStatus
Severance Hospital Seoul Seodaemun-gu Recruiting

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Other trials for the same condition

Home-based Rehabilitation Monitoring System With Wearable Devices and Self-Report Application Active, not recruiting
Feasibility of Vision-Language Models for Detecting Physical Assistance as an Observable Criterion Defining GMFCS Levels in Children Aged 2 to 6 Years With Cerebral Palsy Active, not recruiting
Analyzing Gait Pattern Using Insole-type Gait Analyzer in Patient With Gait Disturbance Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06461923 on ClinicalTrials.gov ↗ ← All trials in South Korea