Cerebral Palsy, Gait Disorders, Neurologic
Conditions
Keywords
gait parameters, smart insole, home-based exercise, monitoring system, rehabilitation
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.
Interventions
DEVICEInsole 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.
Sponsors
Korea Health Industry Development Institute
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute Walking Test | This test results will be assessed two times: baseline and after 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Height (cm) | 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 | — |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 10-meter Walking Test (m/s) | This test results will be assessed two times: baseline and after 6 weeks | — |
| 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 | — |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
South Korea
Contacts
Primary ContactJuntaek Hong
Backup ContactYerim Do
Outcome results
None listed