ArthroplastyNCT03738384
Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty
A study testing Knee Connect + Visual Feedback System in people with Arthroplasty and Replacement, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
The main objective of this pilot study is to determine if using a portable, accelerometer based, visual feedback system improves exercise quality. The secondary objective of this study is to investigate the effect of motivational targets by testing the effects of increasing Range of Motion (ROM) targets. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Replacement, Knee
- What is being tested?
- Knee Connect + Visual Feedback System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 9 Mar 2020to 28 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be enrolled in the "Knee Class" postoperative physiotherapy
- Be able to provide informed consent
- 3-6 weeks post-operative from primary total knee replacement surgery
Who cannot join
- Revision total knee arthroplasty
- Neuromuscular disorder
- Knee Stiffness (knee flexion of <90 degrees during previous Knee Class session)
- Hip Stiffness (hip flexion of <90 degrees)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Sunnybrook Holland Orthopaedic & Arthritic Centre
Toronto, Ontario, M4Y 1H1
About this study
Official title: Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty - Pilot Study
The main objective of this pilot study is to determine if using a portable, accelerometer based, visual feedback system improves exercise quality. The secondary objective of this study is to investigate the effect of motivational targets by testing the effects of increasing Range of Motion (ROM) targets. The results from this study will be used to improve the visual feedback system of the Knee Connect system and serve as starting point for a larger clinical study.
Read the detailed description
The research team will recruit 10 post-op total knee replacement patients who are enrolled in the Knee Class at Sunnybrook Holland Orthopaedic and Arthritic Centre to perform five exercises over two sessions. Each patient will complete five tasks.
- Quarter squats
- Standing hip flexion
- Standing knee flexion
- Sitting knee extension
- Sitting knee flexion
The first three exercises will be performed with and without visual feedback. During standing hip flexion, standing knee flexion and quarter squat exercises, patients will first perform a set of each exercise following an instruction brochure. Patients will then repeat these exercises with the Knee Connect visual feedback system. The KneeConnect will be worn during the entire session, and will record the patient's knee angle and velocity regardless of visual feedback condition.
For the next two exercises, sitting knee extension and sitting knee flexion, patients will perform the first set of exercises (3 repetitions) with visual feedback of their leg position in space but without seeing an end target. The Knee Connect will measure the knee angle during these tests. For the subsequent set, the Knee Connect system will present a visual target for the patient to achieve. This target will be 5 degrees above the patient's maximum terminal knee angle recorded without motivational targets. A third set will be completed with the knee angle target set 10 degrees above the patient's maximum. A caveat to the target modification for seated knee extensions is that target changes to hyperextension, will result in a full extension target.
After each participant has completed the exercises with the KneeConnect system they will be asked to complete a short survey. The survey has been designed to assess the KneeConnect's usefulness and how much participants liked using the system.
After the data collection has been completed each day, the data will be transferred from the smartphone to a secure computer. These files will then be extracted to measure:
- Knee angle during each exercise
- Knee angular velocity during each exercise
A Leven's test will be used on all of the data to assess the equality of variance in each group. Each pair of data will be compared using a paired t-test to test the difference between with/without visual feedback and with/without motivational targets.
- Conditions
- Arthroplasty, Replacement, Knee
- Being tested
- Knee Connect + Visual Feedback System
- Keywords
- Rehabilitation, Visual, Feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knee Connect + Visual Feedback SystemDevice
A device to measure knee angle. It sends data a smartphone or tablet to be displayed as part of a visual feedback system.
| Study group | Role | What they receive |
|---|---|---|
| TKR Patients | Experimental | Any patient 3-6 weeks post-op from a TKR Receives: Device: Knee Connect + Visual Feedback System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee angle (degrees)
The difference in measured knee angle with and without visual feedback.
Measured: One set of measurements 3-6 weeks post TKR
Knee velocity (degrees/s)
The difference in measured knee velocity with and without visual feedback.
Measured: One set of measurements 3-6 weeks post TKR
Secondary outcomes (1)
Peak knee flexion and extension angle (degrees)
The weekly knee range of motion (in degrees) measured by the Knee Connect
Measured: One set of measurements 3-6 weeks post TKR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start9 Mar 2020
- Primary completion22 Sep 2022
- Study completion28 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Wasserstein, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738384
- Sponsor's protocol ID
- 03KINERIS2018
- Status last verified
- Mar 2021
- First submitted
- 26 Oct 2018
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Manniche C, Hesselsoe G, Bentzen L, Christensen I, Lundberg E. Clinical trial of intensive muscle training for chronic low back pain. Lancet. 1988 Dec 24-31;2(8626-8627):1473-6. doi: 10.1016/s0140-6736(88)90944-0.
PubMed 2904582Nwuga, G., & Nwuga, V. (1985). Relative therapeutic efficacy of the Williams and McKenzie protocols in back pain management. Physiotherapy practice, 1(2), 99-105.
Kohles S, Barnes D, Gatchel RJ, Mayer TG. Improved physical performance outcomes after functional restoration treatment in patients with chronic low-back pain. Early versus recent training results. Spine (Phila Pa 1976). 1990 Dec;15(12):1321-4. doi: 10.1097/00007632-199012000-00016.
PubMed 2149211Friedrich M, Cermak T, Maderbacher P. The effect of brochure use versus therapist teaching on patients performing therapeutic exercise and on changes in impairment status. Phys Ther. 1996 Oct;76(10):1082-8. doi: 10.1093/ptj/76.10.1082.
PubMed 8863761Lam, A. W., Varona-Marin, D., Li, Y., Fergenbaum, M., & Kulić, D. (2016). Automated rehabilitation system: Movement measurement and feedback for patients and physiotherapists in the rehabilitation clinic. Human-Computer Interaction, 31(3-4), 294-334.
Lam AW, HajYasien A, Kulic D. Improving rehabilitation exercise performance through visual guidance. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1735-8. doi: 10.1109/EMBC.2014.6943943.
PubMed 25570311Chkeir, A., Jaber, R., Hewson, D. J., Hogrel, J. Y., & Duchêne, J. (2014). Effect of Different Visual Feedback Conditions on Maximal Grip-Strength Assessment. In XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013 (pp. 1127-1131). Springer, Cham.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty - Pilot Study
- ClinicalTrials.gov ID
- NCT03738384
- Acronym / sponsor ID
- 03KINERIS2018
- Conditions
- Arthroplasty, Replacement, Knee
- Keywords
- Rehabilitation, Visual, Feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 28 Sep 2022 (actual)
- First posted
- 13 Nov 2018 (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.
The main objective of this pilot study is to determine if using a portable, accelerometer based, visual feedback system improves exercise quality. The secondary objective of this study is to investigate the effect of motivational targets by testing the effects of increasing Range of Motion (ROM) targets. The results from this study will be used to improve the visual feedback system of the Knee Connect system and serve as starting point for a larger clinical study.
Detailed description
The research team will recruit 10 post-op total knee replacement patients who are enrolled in the Knee Class at Sunnybrook Holland Orthopaedic and Arthritic Centre to perform five exercises over two sessions. Each patient will complete five tasks.
- Quarter squats
- Standing hip flexion
- Standing knee flexion
- Sitting knee extension
- Sitting knee flexion
The first three exercises will be performed with and without visual feedback. During standing hip flexion, standing knee flexion and quarter squat exercises, patients will first perform a set of each exercise following an instruction brochure. Patients will then repeat these exercises with the Knee Connect visual feedback system. The KneeConnect will be worn during the entire session, and will record the patient's knee angle and velocity regardless of visual feedback condition.
For the next two exercises, sitting knee extension and sitting knee flexion, patients will perform the first set of exercises (3 repetitions) with visual feedback of their leg position in space but without seeing an end target. The Knee Connect will measure the knee angle during these tests. For the subsequent set, the Knee Connect system will present a visual target for the patient to achieve. This target will be 5 degrees above the patient's maximum terminal knee angle recorded without motivational targets. A third set will be completed with the knee angle target set 10 degrees above the patient's maximum. A caveat to the target modification for seated knee extensions is that target changes to hyperextension, will result in a full extension target.
After each participant has completed the exercises with the KneeConnect system they will be asked to complete a short survey. The survey has been designed to assess the KneeConnect's usefulness and how much participants liked using the system.
After the data collection has been completed each day, the data will be transferred from the smartphone to a secure computer. These files will then be extracted to measure:
- Knee angle during each exercise
- Knee angular velocity during each exercise
A Leven's test will be used on all of the data to assess the equality of variance in each group. Each pair of data will be compared using a paired t-test to test the difference between with/without visual feedback and with/without motivational targets.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TKR Patients | Experimental | Device: Knee Connect + Visual Feedback SystemAny patient 3-6 weeks post-op from a TKR |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Be enrolled in the "Knee Class" postoperative physiotherapy
- Be able to provide informed consent
- 3-6 weeks post-operative from primary total knee replacement surgery
Key exclusion criteria (4 listed)
- Revision total knee arthroplasty
- Neuromuscular disorder
- Knee Stiffness (knee flexion of <90 degrees during previous Knee Class session)
- Hip Stiffness (hip flexion of <90 degrees)
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 |
|---|---|---|
| Knee Connect + Visual Feedback SystemA device to measure knee angle. It sends data a smartphone or tablet to be displayed as part of a visual feedback system. | Device | TKR Patients |
Primary outcome
Knee angle (degrees)
Time frame: One set of measurements 3-6 weeks post TKR
The difference in measured knee angle with and without visual feedback.
Knee velocity (degrees/s)
Time frame: One set of measurements 3-6 weeks post TKR
The difference in measured knee velocity with and without visual feedback.
1 secondary outcome
Peak knee flexion and extension angle (degrees)
Time frame: One set of measurements 3-6 weeks post TKR
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 2904582Manniche C, Hesselsoe G, Bentzen L, Christensen I, Lundberg E. Clinical trial of intensive muscle training for chronic low back pain. Lancet. 1988 Dec 24-31;2(8626-8627):1473-6. doi: 10.1016/s0140-6736(88)90944-0.
- BackgroundNwuga, G., & Nwuga, V. (1985). Relative therapeutic efficacy of the Williams and McKenzie protocols in back pain management. Physiotherapy practice, 1(2), 99-105.
- Background: PubMed 2149211Kohles S, Barnes D, Gatchel RJ, Mayer TG. Improved physical performance outcomes after functional restoration treatment in patients with chronic low-back pain. Early versus recent training results. Spine (Phila Pa 1976). 1990 Dec;15(12):1321-4. doi: 10.1097/00007632-199012000-00016.
- Background: PubMed 8863761Friedrich M, Cermak T, Maderbacher P. The effect of brochure use versus therapist teaching on patients performing therapeutic exercise and on changes in impairment status. Phys Ther. 1996 Oct;76(10):1082-8. doi: 10.1093/ptj/76.10.1082.
- BackgroundLam, A. W., Varona-Marin, D., Li, Y., Fergenbaum, M., & Kulić, D. (2016). Automated rehabilitation system: Movement measurement and feedback for patients and physiotherapists in the rehabilitation clinic. Human-Computer Interaction, 31(3-4), 294-334.
- Background: PubMed 25570311Lam AW, HajYasien A, Kulic D. Improving rehabilitation exercise performance through visual guidance. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1735-8. doi: 10.1109/EMBC.2014.6943943.
- BackgroundChkeir, A., Jaber, R., Hewson, D. J., Hogrel, J. Y., & Duchêne, J. (2014). Effect of Different Visual Feedback Conditions on Maximal Grip-Strength Assessment. In XIII Mediterranean Conference on Medical and Biological Engineering and Computing 2013 (pp. 1127-1131). Springer, Cham.
- Individual participant dataSharing planned: Undecided
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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.
David Wasserstein, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knee Connect + Visual Feedback System in people with Arthroplasty and Replacement, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee angle (degrees) (time frame: One set of measurements 3-6 weeks post TKR). The study lists 2 primary outcomes in all. 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 NCT03738384, which also lists 7 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 12 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.