Clinical trial NCT06461923: Home-based Gait Rehabilitation Service Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
Official title: Development and Feasibility Study of the Home-based Gait Rehabilitation Service by Using the Insole-type Gait Analysis Device for Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gait Disorders, Neurologic
Cerebral Palsy
Keywords: gait parameters
smart insole
home-based exercise
monitoring system
rehabilitation
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: Korea Health Industry Development Institute
First posted: 2024-06-17
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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 outcomes:
measure: 6-minute Walking Test
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
Secondary outcomes:
measure: Appendicular muscle mass (kg)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Height (cm)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Weight (kg)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Grip Strength Test (kg)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: The number of steps (n)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Calories burned (kcal)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Activity time (min)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Activity distance (km)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Walking speed (m/s)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Stride length (cm)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Left-right gait balance (%)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: 10-meter Walking Test (m/s)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Pediatric Balance Scale (scores)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Gross Motor Function Classification System (levels)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Korean version of Cerebral Palsy Quality of Life (scores)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Korean version of KIDSCREEN-52 (Children & Adolescents) (scores)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Korean version of KIDSCREEN-52 (Parents) (scores)
timeFrame: This test results will be assessed two times: baseline and after 6 weeks
measure: Satisfaction Survey for the Device (scores)
timeFrame: This test results will be assessed once: after 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu
Study officials:
affiliation: Severance Hospital
name: Na Young Kim
role: PRINCIPAL_INVESTIGATOR
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