Arthroplasty, Replacement, KneeNCT03365284
Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation
A study testing Smart Kneebrace with a smart phone app and regular rehabilitation procedure in people with Arthroplasty, Replacement, Knee and Knee Osteoarthritis, run by Peking University People's Hospital.
Trial summary
This study aims to investigate the effect of Smart Kneebrace use for osteoarthritis patients after total knee arhtroplasty (TKA) on post-operative performance. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Knee Osteoarthritis
- What is being tested?
- Smart Kneebrace with a smart phone app and regular rehabilitation procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ready to receive single-side TKA
Who cannot join
- contraindication of surgery
- self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Being tested
- Smart Kneebrace with a smart phone app, regular rehabilitation procedure
- Keywords
- total knee arthroplasty, rehabilitation, Smart Kneebrace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Kneebrace with a smart phone appDevice
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.
regular rehabilitation procedureOther
regular rehabilitation procedure, especially muscle strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Smart Kneebrace | Experimental | Smart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months Receives: Device: Smart Kneebrace with a smart phone app |
| without Smart Kneebrace | Placebo comparator | regular rehabilitation procedure will be applied after surgery Receives: Other: regular rehabilitation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: before operation and 6/12 weeks after operation
Secondary outcomes (2)
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.
Measured: 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.
Measured: before operation and 6/12 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University
- Responsible party
- Principal investigator, Yifan Chen, Peking University People's Hospital
- Investigators
- Jianhao Lin, MD, Principal investigator, Arthritis clinic and research center, Peking University Peoples' Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365284
- Sponsor's protocol ID
- PUPHACRCE
- Status last verified
- Dec 2017
- First submitted
- 25 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 22520559Sosdian 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.
PubMed 25311517Mills 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.
PubMed 23554153Brostrom 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.
PubMed 22867935
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Kneebrace for Continuous Monitoring of Joint Angles During Rehabilitation After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03365284
- Acronym / sponsor ID
- PUPHACRCE
- Keywords
- total knee arthroplasty, rehabilitation, Smart Kneebrace
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smart Kneebrace | Experimental | Device: Smart Kneebrace with a smart phone appSmart Kneebrace with a smart phone app will be used during the rehabilitation after surgery for three months |
| without Smart Kneebrace | Placebo comparator | Other: regular rehabilitation procedureregular rehabilitation procedure will be applied after surgery |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ready to receive single-side TKA
Key exclusion criteria (2 listed)
- contraindication of surgery
- self-reported diseases that cause lower limb disability (for example, cerebrovascular disease especially stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Kneebrace with a smart phone appSmart 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. | Device | Smart Kneebrace |
| regular rehabilitation procedureregular rehabilitation procedure, especially muscle strengthening exercises | Other | without Smart Kneebrace |
Primary outcome
The change of postoperative joint angles
Time frame: before operation and 6/12 weeks after operation
Patients in both groups will wear the smart kneebrace by which the range of motion of the knee joint can be calculated.
2 secondary outcomes
The change of knee pain.
Time frame: before operation and 6/12 weeks after operation
The change of knee symptoms.
Time frame: before operation and 6/12 weeks after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Background: PubMed 22520559Patel 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.
- Background: PubMed 25311517Sosdian 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.
- Background: PubMed 23554153Mills 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.
- Background: PubMed 22867935Brostrom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhao Lin, MD principal investigator
Arthritis clinic and research center, Peking University Peoples' Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Smart Kneebrace with a smart phone app and regular rehabilitation procedure in people with Arthroplasty, Replacement, Knee and Knee Osteoarthritis, run by Peking University People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiwei Zhou (+8613521817377, zzwwwdz@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of postoperative joint angles (time frame: before operation and 6/12 weeks after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365284, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.