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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461923
• Other study ID #: 4-2023-1407
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Yonsei University
• Contact: Juntaek Hong
• Phone: +82 010 6517 7526
• Email: GHDWNSXOR[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: June 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with cerebral palsy aged 7 to 18 years old

2. Patients classified as Gross Motor Function Classification System level 1 or 2

3. Individuals who visited Severance Hospital, comprehended the study, agreed to participate, and submitted the informed consent form

Exclusion Criteria:

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

2. 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

Related Conditions & MeSH terms

• Cerebral Palsy
• Gait Disorders, Neurologic
• Nervous System Diseases

Intervention

Device:
• Insole wearing
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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul	Seodaemun-gu

Sponsors (2)

Lead Sponsor	Collaborator
Yonsei University	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (15)

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. — View Citation

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. — View Citation

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: 10.3109/09638288.2012.71 — View Citation

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. — View Citation

Fritz S, Lusardi M. White paper: "walking speed: the sixth vital sign". J Geriatr Phys Ther. 2009;32(2):46-9. No abstract available. Erratum In: J Geriatr Phys Ther. 2009;32(3):110. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute Walking Test		This test results will be assessed two times: baseline and after 6 weeks
Secondary	Appendicular muscle mass (kg)	This outcome will be measured using bioelectrical impedance.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Height (cm)	This outcome will be measured using bioelectrical impedance.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Weight (kg)	This outcome will be measured using bioelectrical impedance.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Grip Strength Test (kg)		This test results will be assessed two times: baseline and after 6 weeks
Secondary	The number of steps (n)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Calories burned (kcal)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Activity time (min)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Activity distance (km)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Walking speed (m/s)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Stride length (cm)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Left-right gait balance (%)	This outcome will be collected using an insole-type gait analyzer.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	10-meter Walking Test (m/s)		This test results will be assessed two times: baseline and after 6 weeks
Secondary	Pediatric Balance Scale (scores)	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.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Gross Motor Function Classification System (levels)		This test results will be assessed two times: baseline and after 6 weeks
Secondary	Korean version of Cerebral Palsy Quality of Life (scores)	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.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Korean version of KIDSCREEN-52 (Children & Adolescents) (scores)	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.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Korean version of KIDSCREEN-52 (Parents) (scores)	The minimum score is 52 points, and the maximum score is 260 points. A higher score indicates a higher quality of life.	This test results will be assessed two times: baseline and after 6 weeks
Secondary	Satisfaction Survey for the Device (scores)	The minimum score is 12, and the maximum score is 84 points. A higher score indicates lower satisfaction.	This test results will be assessed once: after 6 weeks