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Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

NCT ID: NCT03365284

Last Updated: 2017-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-31

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.

Conditions

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Arthroplasty, Replacement, Knee Knee Osteoarthritis

Keywords

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total knee arthroplasty rehabilitation Smart Kneebrace

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Smart Kneebrace

Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months

Group Type EXPERIMENTAL

Smart Kneebrace with a smart phone app

Intervention Type DEVICE

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.

without Smart Kneebrace

regular rehabilitation procedure will be applied after surgery

Group Type PLACEBO_COMPARATOR

regular rehabilitation procedure

Intervention Type OTHER

regular rehabilitation procedure, especially muscle strengthening exercises

Interventions

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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.

Intervention Type DEVICE

regular rehabilitation procedure

regular rehabilitation procedure, especially muscle strengthening exercises

Intervention Type OTHER

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)
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yifan Chen

Clinical professor ofarthritis clinic and research center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jianhao Lin, MD

Role: PRINCIPAL_INVESTIGATOR

Arthritis clinic and research center, Peking University Peoples' Hospital

Central Contacts

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Zhiwei Zhou

Role: CONTACT

Phone: +8613521817377

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 22520559 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25311517 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23554153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22867935 (View on PubMed)

Other Identifiers

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PUPHACRCE

Identifier Type: -

Identifier Source: org_study_id