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

NCT06461923 | Recruiting

• 1 other identifier: 4-2023-1407
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Gait Disorders, Neurologic; Cerebral Palsy

Keywords

gait parameters; smart insole; home-based exercise; monitoring system; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6-minute Walking Test

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

Secondary Outcomes (18)

• Appendicular muscle mass (kg)

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

• Height (cm)

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

• Weight (kg)

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

• 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

Study Arms (1)

Insole wearing

EXPERIMENTAL

Device: Insole wearing

Interventions

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.

Insole wearing

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Severance Hospital

Seoul, Seodaemun-gu, 03722, South Korea

RECRUITING

Related Publications (15)

• Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.

  PMID: 20590073 RESULT

• Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.

  PMID: 20039582 RESULT

• Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.

  PMID: 24812254 RESULT

• Stolze H, Klebe S, Baecker C, Zechlin C, Friege L, Pohle S, Deuschl G. Prevalence of gait disorders in hospitalized neurological patients. Mov Disord. 2005 Jan;20(1):89-94. doi: 10.1002/mds.20266.

  PMID: 15390043 RESULT

• Giladi N, Horak FB, Hausdorff JM. Classification of gait disturbances: distinguishing between continuous and episodic changes. Mov Disord. 2013 Sep 15;28(11):1469-73. doi: 10.1002/mds.25672.

  PMID: 24132835 RESULT

• Carlon SL, Taylor NF, Dodd KJ, Shields N. Differences in habitual physical activity levels of young people with cerebral palsy and their typically developing peers: a systematic review. Disabil Rehabil. 2013 Apr;35(8):647-55. doi: 10.3109/09638288.2012.715721. Epub 2012 Oct 17.

  PMID: 23072296 RESULT

• Waltersson L, Rodby-Bousquet E. Physical Activity in Adolescents and Young Adults with Cerebral Palsy. Biomed Res Int. 2017;2017:8080473. doi: 10.1155/2017/8080473. Epub 2017 Dec 20.

  PMID: 29423412 RESULT

• O'Connell NE, Smith KJ, Peterson MD, Ryan N, Liverani S, Anokye N, Victor C, Ryan JM. Incidence of osteoarthritis, osteoporosis and inflammatory musculoskeletal diseases in adults with cerebral palsy: A population-based cohort study. Bone. 2019 Aug;125:30-35. doi: 10.1016/j.bone.2019.05.007. Epub 2019 May 8.

  PMID: 31075418 RESULT

• Mcphee PG, Claridge EA, Noorduyn SG, Gorter JW. Cardiovascular disease and related risk factors in adults with cerebral palsy: a systematic review. Dev Med Child Neurol. 2019 Aug;61(8):915-923. doi: 10.1111/dmcn.14028. Epub 2018 Sep 17.

  PMID: 30221763 RESULT

• Bulekbayeva S, Daribayev Z, Ospanova S, Vento S. Cerebral palsy: a multidisciplinary, integrated approach is essential. Lancet Glob Health. 2017 Apr;5(4):e401. doi: 10.1016/S2214-109X(17)30082-7. No abstract available.

  PMID: 28288745 RESULT

• Muro-de-la-Herran A, Garcia-Zapirain B, Mendez-Zorrilla A. Gait analysis methods: an overview of wearable and non-wearable systems, highlighting clinical applications. Sensors (Basel). 2014 Feb 19;14(2):3362-94. doi: 10.3390/s140203362.

  PMID: 24556672 RESULT

• Ngueleu AM, Blanchette AK, Maltais D, Moffet H, McFadyen BJ, Bouyer L, Batcho CS. Validity of Instrumented Insoles for Step Counting, Posture and Activity Recognition: A Systematic Review. Sensors (Basel). 2019 May 28;19(11):2438. doi: 10.3390/s19112438.

  PMID: 31141973 RESULT

• Andreoli A, Garaci F, Cafarelli FP, Guglielmi G. Body composition in clinical practice. Eur J Radiol. 2016 Aug;85(8):1461-8. doi: 10.1016/j.ejrad.2016.02.005. Epub 2016 Feb 15.

  PMID: 26971404 RESULT

• Lee SY. Handgrip Strength: An Irreplaceable Indicator of Muscle Function. Ann Rehabil Med. 2021 Jun;45(3):167-169. doi: 10.5535/arm.21106. Epub 2021 Jun 30. No abstract available.

  PMID: 34233405 RESULT

• Chrysagis N, Skordilis EK, Koutsouki D. Validity and clinical utility of functional assessments in children with cerebral palsy. Arch Phys Med Rehabil. 2014 Feb;95(2):369-74. doi: 10.1016/j.apmr.2013.10.025. Epub 2013 Nov 12.

  PMID: 24239880 RESULT

MeSH Terms

Conditions

Gait Disorders, Neurologic; Cerebral Palsy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Na Young Kim

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juntaek Hong

CONTACT

+82 010 6517 7526; GHDWNSXOR@yuhs.ac

Yerim Do

CONTACT

+82 010 7154 6011; doyr62@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 17, 2024
• Study Start: August 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)