Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

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

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

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Arthroplasty, Replacement, Knee
• Intervention / Treatment: Device: Smart Kneebrace with a smart phone app; Other: regular rehabilitation procedure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Kneebrace; Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months	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.
Placebo Comparator: without Smart Kneebrace; regular rehabilitation procedure will be applied after surgery	Other: regular rehabilitation procedure; regular rehabilitation procedure, especially muscle strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University
• Investigators: Principal Investigator: Jianhao Lin, MD, Arthritis clinic and research center, Peking University Peoples' Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 25, 2017
• First Submitted That Met QC Criteria: December 2, 2017
• First Posted (Actual): December 7, 2017

Study Record Updates

• Last Update Posted (Actual): December 7, 2017
• Last Update Submitted That Met QC Criteria: December 2, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: rehabilitation; total knee arthroplasty; Smart Kneebrace
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: PUPHACRCE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No