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Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03365284
Enrollment
60
Registered
2017-12-07
Start date
2018-01-01
Completion date
2019-12-31
Last updated
2017-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Knee Osteoarthritis

Keywords

total knee arthroplasty, rehabilitation, Smart Kneebrace

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.

Interventions

DEVICESmart 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.

OTHERregular rehabilitation procedure

regular rehabilitation procedure, especially muscle strengthening exercises

Sponsors

Peking University
CollaboratorOTHER
Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
The change of postoperative joint anglesbefore operation and 6/12 weeks after operationPatients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.

Secondary

MeasureTime frameDescription
The change of knee symptoms.before operation and 6/12 weeks after operationThe 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.
The change of knee pain.before operation and 6/12 weeks after operationVisual 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.

Contacts

Primary ContactZhiwei Zhou
zzwwwdz@sina.com+8613521817377

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026