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Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation

Primary Purpose

Arthroplasty, Replacement, Knee, Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Smart Kneebrace with a smart phone app
regular rehabilitation procedure
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty, Replacement, Knee focused on measuring total knee arthroplasty, rehabilitation, Smart Kneebrace

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Smart Kneebrace

    without Smart Kneebrace

    Arm Description

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

    regular rehabilitation procedure will be applied after surgery

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.

    Full Information

    First Posted
    November 25, 2017
    Last Updated
    December 2, 2017
    Sponsor
    Peking University People's Hospital
    Collaborators
    Peking University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03365284
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital
    Collaborators
    Peking University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arthroplasty, Replacement, Knee, Knee Osteoarthritis
    Keywords
    total knee arthroplasty, rehabilitation, Smart Kneebrace

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Smart Kneebrace
    Arm Type
    Experimental
    Arm Description
    Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months
    Arm Title
    without Smart Kneebrace
    Arm Type
    Placebo Comparator
    Arm Description
    regular rehabilitation procedure will be applied after surgery
    Intervention Type
    Device
    Intervention Name(s)
    Smart Kneebrace with a smart phone app
    Intervention Description
    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
    Other
    Intervention Name(s)
    regular rehabilitation procedure
    Intervention Description
    regular rehabilitation procedure, especially muscle strengthening exercises
    Primary Outcome Measure Information:
    Title
    The change of postoperative joint angles
    Description
    Patients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.
    Time Frame
    before operation and 6/12 weeks after operation
    Secondary Outcome Measure Information:
    Title
    The change of knee pain.
    Description
    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.
    Time Frame
    before operation and 6/12 weeks after operation
    Title
    The change of knee symptoms.
    Description
    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.
    Time Frame
    before operation and 6/12 weeks after operation

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiwei Zhou
    Phone
    +8613521817377
    Email
    zzwwwdz@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianhao Lin, MD
    Organizational Affiliation
    Arthritis clinic and research center, Peking University Peoples' Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    22520559
    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.
    Results Reference
    background
    PubMed Identifier
    25311517
    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.
    Results Reference
    background
    PubMed Identifier
    23554153
    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.
    Results Reference
    background
    PubMed Identifier
    22867935
    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.
    Results Reference
    background

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