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NCT Number: NCT06461923

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

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.

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Key information

Conditions

Gait Disorders, Neurologic Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with cerebral palsy aged 7 to 18 years old
  • Patients classified as Gross Motor Function Classification System level 1 or 2
  • Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and submitted the informed consent form

Exclusion criteria

  • Individuals with complications such as severe foot deformities where the sensors of the insole gait analysis device cannot be recognized
  • 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

Treatment and study plan

Insole wearing

Device

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.

Primary outcomes

  1. 6-minute Walking Test

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

Secondary outcomes

  1. Appendicular muscle mass (kg)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be measured using bioelectrical impedance.

  2. Height (cm)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be measured using bioelectrical impedance.

  3. Weight (kg)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be measured using bioelectrical impedance.

  4. Grip Strength Test (kg)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

  5. The number of steps (n)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be collected using an insole-type gait analyzer.

  6. Calories burned (kcal)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be collected using an insole-type gait analyzer.

  7. Activity time (min)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be collected using an insole-type gait analyzer.

  8. Activity distance (km)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be collected using an insole-type gait analyzer.

  9. Walking speed (m/s)

    Time frame: 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. Stride length (cm)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be collected using an insole-type gait analyzer.

  11. Left-right gait balance (%)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

    This outcome will be collected using an insole-type gait analyzer.

  12. 10-meter Walking Test (m/s)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

  13. Pediatric Balance Scale (scores)

    Time frame: 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.

  14. Gross Motor Function Classification System (levels)

    Time frame: This test results will be assessed two times: baseline and after 6 weeks

  15. Korean version of Cerebral Palsy Quality of Life (scores)

    Time frame: 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.

  16. Korean version of KIDSCREEN-52 (Children & Adolescents) (scores)

    Time frame: 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.

  17. Korean version of KIDSCREEN-52 (Parents) (scores)

    Time frame: 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.

  18. Satisfaction Survey for the Device (scores)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Juntaek Hong

CONTACT

[email protected]

+82 010 6517 7526

Yerim Do

CONTACT

[email protected]

+82 010 7154 6011

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Korea Health Industry Development Institute

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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