Actively Recruiting

Phase Not Applicable
Age: 7Years - 18Years
All Genders
ID06461923

Development and Feasibility Study of the Home-based Gait Rehabilitation Service Using an Insole-type Gait Analysis Device for Children With Cerebral Palsy

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

10

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

Y

Yonsei University

Lead Sponsor

K

Korea Health Industry Development Institute

Collaborating Sponsor

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

Eligible

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
Not Eligible

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

AI-Screening

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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

Trial Site Locations

Total: 1 location

1

Severance Hospital

Seoul, Seodaemun-gu, South Korea, 03722

Actively Recruiting

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Research Team

J

Juntaek Hong

Y

Yerim Do

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

1

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Published Research Related To This Trial

Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review.

Stacey L Carlon, Nicholas F Taylor, Karen J Dodd...

https://pubmed.ncbi.nlm.nih.gov/23072296

Incidence of osteoarthritis, osteoporosis and inflammatory musculoskeletal diseases in adults with cerebral palsy: A population-based cohort study.

Neil E O'Connell, Kimberley J Smith, Mark D Peterson...

https://pubmed.ncbi.nlm.nih.gov/31075418