Home-based Gait Rehabilitation Service Using Instrumented Insole
NCT ID: NCT06410755
Last Updated: 2025-02-11
Study Results
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2024-03-12
2025-12-31
Brief Summary
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The main questions it aims to to answer are:
* What effect does providing monitoring and feedback using an insole-type gait analyzer have on walking patterns?
* How satisfied are the experimental group participants with the use of the insole gait analyzer?
Researchers will compare the experimental group that receives the insole-type gait analyzer with the control group that does not receive it.
Participants will:
* Receive an insole-type gait analyzer and receive training in a home-based exercise program.
* During the 6-week program, participants will wear an insole-type gait analyzer and perform a home-based exercise program.
* The investigators will conduct a satisfaction survey after 6 weeks.
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Detailed Description
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The researcher provides the insole gait analyzers to the experimental group, trains them on how to use them, and instructs them to wear them as much and for as long as possible so that their usage time and gait patterns are recorded. The researcher provides feedback over the phone once a week based on the collected measurement data. The control group was not provided with an insole-type gait analyzer or feedback on their exercise.
At the end of the home-based exercise program after 6 weeks, an exit assessment is conducted, identical to the initial assessment, and the experimental group is asked to rate their satisfaction with the insole gait analyzer.
Measures are taken and recorded when a device malfunction occurs, the use and satisfaction level of the insole-type gait analyzer in the experimental group are analyzed, and evaluation indicators before and after the program for the experimental and control groups are compared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. Experimental group The experimental group wears the insole gait analyzer and is asked to wear the insole gait analyzer as much and as long as possible during outdoor activities. Researchers provide feedback to subjects once a week based on the collected measurement data. After 6 weeks, usability and satisfaction evaluation of the insole type gait analysis system will be conducted.
3. Control group The control group is trained in the same exercise program as the experimental group, but not receives the insole gait analyzers and not receives any exercise feedback.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Insole wearing group receiving monitoring and feedback
The experimental group wears the insole gait analyzer and is asked to wear the insole gait analyzer as much and as long as possible during outdoor activities. Researchers provide feedback to subjects once a week based on the collected measurement data. After 6 weeks, usability and satisfaction evaluation of the insole type gait analysis system will be conducted.
Monitoring system using a insole-type gait analyzer
The researcher provides feedback over the phone once a week in accordance with the subjects' amount of exercise and walking level collected only to the experimental group using the insole-type gait analysis system. Check the stability of data collection, and if an abnormality occurs, take action and record it by phone or in person
Control group
The control group is trained in the same exercise program as the experimental group, but not receives the insole gait analyzers and not receives any exercise feedback.
No interventions assigned to this group
Interventions
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Monitoring system using a insole-type gait analyzer
The researcher provides feedback over the phone once a week in accordance with the subjects' amount of exercise and walking level collected only to the experimental group using the insole-type gait analysis system. Check the stability of data collection, and if an abnormality occurs, take action and record it by phone or in person
Eligibility Criteria
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Inclusion Criteria
2. Patients with a score of 2-3 on the Modified Rankin Scale who are ambulatory
3. Patients who visited Yongin Severance Hospital who understood and agreed to the study and completed the informed consent form
Exclusion Criteria
2. Progressive or unstable brain disease
3. In addition to above, those who have clinically significant findings that are deemed inappropriate for this study in the medical judgment of the study director or person in charge
19 Years
ALL
No
Sponsors
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Korea Health Industry Development Institute
OTHER_GOV
Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Na Young Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Locations
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Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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Kang Y, NA DL, Hahn S. A validity study on the Korean Mini-Mental State Examination (K-MMSE) in dementia patients. Journal of the Korean neurological association 1997:300-308
Bae JN, Cho MJ. Development of the Korean version of the Geriatric Depression Scale and its short form among elderly psychiatric patients. J Psychosom Res. 2004 Sep;57(3):297-305. doi: 10.1016/j.jpsychores.2004.01.004.
Kim S, Kim M, Won CW. Validation of the Korean Version of the SARC-F Questionnaire to Assess Sarcopenia: Korean Frailty and Aging Cohort Study. J Am Med Dir Assoc. 2018 Jan;19(1):40-45.e1. doi: 10.1016/j.jamda.2017.07.006. Epub 2017 Aug 31.
Mehrholz J, Wagner K, Rutte K, Meissner D, Pohl M. Predictive validity and responsiveness of the functional ambulation category in hemiparetic patients after stroke. Arch Phys Med Rehabil. 2007 Oct;88(10):1314-9. doi: 10.1016/j.apmr.2007.06.764.
Kim Heon-tae, Moon Jun-bae, Ryu Seung-ho, and Kang Min-soo. Validity study of the Korean version of the International Physical Activity Questionnaire (IPAQ): Verification of construct-related validity. Korean Journal of Physical Education No. 2017;56
Swanson AB, Matev IB, de Groot G. The strength of the hand. Bull Prosthet Res. 1970 Fall;10(14):145-53. No abstract available.
Rockwood K, Song X, MacKnight C, Bergman H, Hogan DB, McDowell I, Mitnitski A. A global clinical measure of fitness and frailty in elderly people. CMAJ. 2005 Aug 30;173(5):489-95. doi: 10.1503/cmaj.050051.
Nowels D, McGloin J, Westfall JM, Holcomb S. Validation of the EQ-5D quality of life instrument in patients after myocardial infarction. Qual Life Res. 2005 Feb;14(1):95-105. doi: 10.1007/s11136-004-0614-4.
Vellas B, Villars H, Abellan G, Soto ME, Rolland Y, Guigoz Y, Morley JE, Chumlea W, Salva A, Rubenstein LZ, Garry P. Overview of the MNA--Its history and challenges. J Nutr Health Aging. 2006 Nov-Dec;10(6):456-63; discussion 463-5.
Won CW, Rho YG, Kim SY, Cho BR, Lee YS. The validity and reliability of Korean Activities of Daily Living (K-ADL) scale. Journal of the Korean Geriatrics Society 2002;6:98-106
KANG SJ, Choi SH, LEE BH, KWON JC, NA DL, Han SH. The reliability and validity of the Korean Instrumental Activities of Daily Living (K-IADL). Journal of the Korean Neurological Association 2002:8-14
Gomez JF, Curcio CL, Alvarado B, Zunzunegui MV, Guralnik J. Validity and reliability of the Short Physical Performance Battery (SPPB): a pilot study on mobility in the Colombian Andes. Colomb Med (Cali). 2013 Sep 30;44(3):165-71. eCollection 2013 Jul.
Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.
Godi M, Franchignoni F, Caligari M, Giordano A, Turcato AM, Nardone A. Comparison of reliability, validity, and responsiveness of the mini-BESTest and Berg Balance Scale in patients with balance disorders. Phys Ther. 2013 Feb;93(2):158-67. doi: 10.2522/ptj.20120171. Epub 2012 Sep 27.
Dolny DG, Collins MG, Wilson T, Germann ML, Davis HP. Validity of lower extremity strength and power utilizing a new closed chain dynamometer. Med Sci Sports Exerc. 2001 Jan;33(1):171-5. doi: 10.1097/00005768-200101000-00026.
Tudor-Locke C, Han H, Aguiar EJ, Barreira TV, Schuna JM Jr, Kang M, Rowe DA. How fast is fast enough? Walking cadence (steps/min) as a practical estimate of intensity in adults: a narrative review. Br J Sports Med. 2018 Jun;52(12):776-788. doi: 10.1136/bjsports-2017-097628.
Murtagh EM, Mair JL, Aguiar E, Tudor-Locke C, Murphy MH. Outdoor Walking Speeds of Apparently Healthy Adults: A Systematic Review and Meta-analysis. Sports Med. 2021 Jan;51(1):125-141. doi: 10.1007/s40279-020-01351-3.
Iosa M, Fusco A, Marchetti F, Morone G, Caltagirone C, Paolucci S, Peppe A. The golden ratio of gait harmony: repetitive proportions of repetitive gait phases. Biomed Res Int. 2013;2013:918642. doi: 10.1155/2013/918642. Epub 2013 Jun 4.
She J, Nakamura H, Makino K, Ohyama Y, Hashimoto H. Selection of suitable maximum-heart-rate formulas for use with Karvonen formula to calculate exercise intensity. International journal of automation and computing 2015;12:62-69
Speed C, Arneil T, Harle R, Wilson A, Karthikesalingam A, McConnell M, Phillips J. Measure by measure: Resting heart rate across the 24-hour cycle. PLOS Digit Health. 2023 Apr 28;2(4):e0000236. doi: 10.1371/journal.pdig.0000236. eCollection 2023 Apr.
Lee SH, Jung BK, Park SY. Korean translation and psychometric properties of Quebec user evaluation of satisfaction assistive technology 2.0. Journal of the Korea Academia-Industrial Cooperation Society 2013;14:3284-3292
Salzman B. Gait and balance disorders in older adults. Am Fam Physician. 2010 Jul 1;82(1):61-8.
Bennett DA, Beckett LA, Murray AM, Shannon KM, Goetz CG, Pilgrim DM, Evans DA. Prevalence of parkinsonian signs and associated mortality in a community population of older people. N Engl J Med. 1996 Jan 11;334(2):71-6. doi: 10.1056/NEJM199601113340202.
Lamoth CJ, Stins JF, Pont M, Kerckhoff F, Beek PJ. Effects of attention on the control of locomotion in individuals with chronic low back pain. J Neuroeng Rehabil. 2008 Apr 25;5:13. doi: 10.1186/1743-0003-5-13.
Lange AK, Vanwanseele B, Fiatarone Singh MA. Strength training for treatment of osteoarthritis of the knee: a systematic review. Arthritis Rheum. 2008 Oct 15;59(10):1488-94. doi: 10.1002/art.24118.
Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available.
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.
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.
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.
Kirtley C. Clinical gait analysis: theory and practice: Elsevier Health Sciences; 2006
Guyatt GH, Sullivan MJ, Thompson PJ, Fallen EL, Pugsley SO, Taylor DW, Berman LB. The 6-minute walk: a new measure of exercise capacity in patients with chronic heart failure. Can Med Assoc J. 1985 Apr 15;132(8):919-23.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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9-2023-0194
Identifier Type: -
Identifier Source: org_study_id
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