What is this study trying to find out about cerebral palsy?

This study is evaluating how well an insole gait analysis device works to monitor walking and provide feedback for children with cerebral palsy who have walking difficulties. Researchers want to see if the device is easy to use and if it helps with a home exercise program. The study is sponsored by Yonsei University.

Who may be eligible for this cerebral palsy clinical trial?

Children between 7 and 18 years old diagnosed with cerebral palsy who are able to walk independently for more than 10 meters may be eligible. Participants should be classified as level 1 or 2 on the Gross Motor Function Classification System. Please review eligibility criteria for more details.

Is there any cost to participate in this cerebral palsy clinical trial?

Study-related care, including the device and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 7Years - 18Years

All Genders

ID06461923

Home-Based Gait Rehabilitation Using an Insole Gait Analysis Device for Children with Cerebral Palsy Ages 7 to 18

Led by Yonsei University · Updated on 2025-02-10

Participants Needed

Research Sites

4 weeks

Total Duration

AI-Summary

What this Trial Is About

Walking is an essential daily activity that requires complex muscle coordination and is important for bone and muscle health, cardiovascular fitness, and daily living activities. This research evaluates the usability and satisfaction of an insole gait analysis device to monitor and provide feedback on walking in children with cerebral palsy who have walking impairments. The study also assesses adherence to a home-based exercise program developed for this population. Participants who can walk independently for more than 10 meters will undergo an initial evaluation, including baseline symptom assessment and walking status feedback. They will then use an insole gait analysis device during their outdoor activities and follow a 6-week home exercise program, recording their exercises in a log. Feedback on their walking patterns and device use will be provided by phone during weeks 3 to 4, and a final evaluation will be conducted after 6 weeks to assess device satisfaction and changes in walking. Throughout the study, participants will be evaluated using various tests, including the 6-minute walking test, grip strength, walking speed, gait balance, and quality of life questionnaires at baseline and after 6 weeks. Researchers will analyze device usage, satisfaction, and exercise adherence through logs. The total participation duration is approximately 6 weeks, with assessments before, during, and after the intervention.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 7Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

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, understood the study, agreed to participate, and submitted informed consent

You will not qualify if you...

Individuals with severe foot deformities preventing recognition by the insole gait analysis device sensors
Individuals with clinically significant findings deemed inappropriate for the study by medical judgment

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 6 weeks

Participants use an insole-type gait analysis device during their outdoor activities and follow a 6-week home exercise program. They keep an exercise log and receive feedback by phone during weeks 3 to 4 based on the device data.

1 baseline visit and 1 follow-up visit (in-person), plus 1 phone feedback call during weeks 3 to 4