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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
10
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.
Severance Hospital
Seoul, Seodaemun-gu, South Korea
RECRUITING6-minute Walking Test
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Appendicular muscle mass (kg)
This outcome will be measured using bioelectrical impedance.
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Height (cm)
This outcome will be measured using bioelectrical impedance.
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Weight (kg)
This outcome will be measured using bioelectrical impedance.
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Grip Strength Test (kg)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This test results will be assessed two times: baseline and after 6 weeks
10-meter Walking Test (m/s)
Time frame: 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.
Time frame: This test results will be assessed two times: baseline and after 6 weeks
Gross Motor Function Classification System (levels)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This test results will be assessed once: after 6 weeks
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