Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

Knee Osteoarthritis Clinical Trial

Official title:

Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation After Total Knee Arthroplasty

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03365284
• Other study ID #: PUPHACRCE
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: December 2, 2017
• Start date: January 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: Peking University People's Hospital
• Contact: Zhiwei Zhou
• Phone: +8613521817377
• Email: zzwwwdz[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients after total knee arhtroplasty (TKA) on post-operative performance.

Description:

This is a single-center, open-label randomized controlled clinical trail. A total of 60 participants will receive total knee arthroplasty, who will be randomly assigned into experiment or control group. Smart Kneebrace will be used for the patients during the rehabilitation for the patients in experiment group, while the patients in the control group will not receive such a smart kneebrace. Postoperative joint angles as well as visual analog scale pain score, the Western Ontario and McMaster Universities Osteoarthritis Index knee society score will be estimated before operation and at 6/12 weeks after operation.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

Inclusion Criteria:

• Ready to receive single-side TKA

Exclusion Criteria:

• contraindication of surgery

• self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)

Related Conditions & MeSH terms

• Arthroplasty, Replacement, Knee
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Smart Kneebrace with a smart phone app
Smart Kneebrace will be used during the rehabilitation. Patients wearing the Smart KneeBrace are able to know their daily activity summary and exercise performance during rehabilitation training through a smart phone app.

Other:
• regular rehabilitation procedure
regular rehabilitation procedure, especially muscle strengthening exercises

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Peking University

References & Publications (4)

Broström EW, Esbjörnsson AC, von Heideken J, Iversen MD. Gait deviations in individuals with inflammatory joint diseases and osteoarthritis and the usage of three-dimensional gait analysis. Best Pract Res Clin Rheumatol. 2012 Jun;26(3):409-22. doi: 10.1016/j.berh.2012.05.007. Review. — View Citation

Mills K, Hunt MA, Ferber R. Biomechanical deviations during level walking associated with knee osteoarthritis: a systematic review and meta-analysis. Arthritis Care Res (Hoboken). 2013 Oct;65(10):1643-65. doi: 10.1002/acr.22015. Review. — View Citation

Patel S, Park H, Bonato P, Chan L, Rodgers M. A review of wearable sensors and systems with application in rehabilitation. J Neuroeng Rehabil. 2012 Apr 20;9:21. doi: 10.1186/1743-0003-9-21. Review. — View Citation

Sosdian L, Dobson F, Wrigley TV, Paterson K, Bennell K, Dowsey M, Choong P, Allison K, Hinman RS. Longitudinal changes in knee kinematics and moments following knee arthroplasty: a systematic review. Knee. 2014 Dec;21(6):994-1008. doi: 10.1016/j.knee.2014.09.009. Epub 2014 Oct 12. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of postoperative joint angles	Patients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.	before operation and 6/12 weeks after operation
Secondary	The change of knee pain.	Visual Analogue Scale of pain is a scale to extimate pain, and its score ranges from 0 to 10. The higher the score is, the more severe pain the patient is feeling.	before operation and 6/12 weeks after operation
Secondary	The change of knee symptoms.	The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC),and its score ranges from 0 to 96. The higher the score is, the more severe symptoms the patient is feeling.	before operation and 6/12 weeks after operation