Clinical trial NCT03365284: Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation
Official title: Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation After Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Knee Osteoarthritis
Keywords: total knee arthroplasty
rehabilitation
Smart Kneebrace
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2017-12-07
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: The change of postoperative joint angles
timeFrame: before operation and 6/12 weeks after operation
Secondary outcomes:
measure: The change of knee pain.
timeFrame: before operation and 6/12 weeks after operation
measure: The change of knee symptoms.
timeFrame: before operation and 6/12 weeks after operation
Other outcomes:
Locations:
Study officials:
affiliation: Arthritis clinic and research center, Peking University Peoples' Hospital
name: Jianhao Lin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: Brostrom EW, Esbjornsson 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.