Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arthroplasty, Replacement, Knee, Knee Osteoarthritis

Intervention / Treatment
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* Device: Smart Kneebrace with a smart phone app
* Other: regular rehabilitation procedure


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Kneebrace<br>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<br>* 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.<br>|
| Placebo Comparator: without Smart Kneebrace<br>regular rehabilitation procedure will be applied after surgery | Other: regular rehabilitation procedure<br>* regular rehabilitation procedure, especially muscle strengthening exercises<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee arthroplasty, rehabilitation, Smart Kneebrace