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

Not Applicable

Recruiting

• Conditions: Cerebral Palsy; Gait Disorders, Neurologic
• Interventions: Device: Insole wearing

• Registration Number: NCT06461923
• Lead Sponsor: Yonsei University

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.

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.

Study Timeline

• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-06-11
• Study First Posted: 2024-06-17
• Study Start: 2024-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-10
• Primary Completion: 2025-05
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Insole wearing	Insole wearing	-

Primary Outcome Measures

Name	Time	Method
6-minute Walking Test	This test results will be assessed two times: baseline and after 6 weeks

Secondary Outcome Measures

Name	Time	Method
Calories burned (kcal)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Walking speed (m/s)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Stride length (cm)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Korean version of Cerebral Palsy Quality of Life (scores)	This test results will be assessed two times: baseline and after 6 weeks	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.
Appendicular muscle mass (kg)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be measured using bioelectrical impedance.
Weight (kg)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be measured using bioelectrical impedance.
Grip Strength Test (kg)	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
Korean version of KIDSCREEN-52 (Parents) (scores)	This test results will be assessed two times: baseline and after 6 weeks	The minimum score is 52 points, and the maximum score is 260 points. A higher score indicates a higher quality of life.
Satisfaction Survey for the Device (scores)	This test results will be assessed once: after 6 weeks	The minimum score is 12, and the maximum score is 84 points. A higher score indicates lower satisfaction.
The number of steps (n)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Activity time (min)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Pediatric Balance Scale (scores)	This test results will be assessed two times: baseline and after 6 weeks	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.
Gross Motor Function Classification System (levels)	This test results will be assessed two times: baseline and after 6 weeks
Height (cm)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be measured using bioelectrical impedance.
Left-right gait balance (%)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Activity distance (km)	This test results will be assessed two times: baseline and after 6 weeks	This outcome will be collected using an insole-type gait analyzer.
Korean version of KIDSCREEN-52 (Children & Adolescents) (scores)	This test results will be assessed two times: baseline and after 6 weeks	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.

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Seodaemun-gu, Korea, Republic of