Clinical trial NCT03738384: Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty
Official title: Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty
Replacement
Knee
Keywords: Rehabilitation, Visual, Feedback
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2018-11-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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.

1. Quarter squats
2. Standing hip flexion
3. Standing knee flexion
4. Sitting knee extension
5. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Knee angle (degrees)
timeFrame: One set of measurements 3-6 weeks post TKR
measure: Knee velocity (degrees/s)
timeFrame: One set of measurements 3-6 weeks post TKR
Secondary outcomes:
measure: Peak knee flexion and extension angle (degrees)
timeFrame: One set of measurements 3-6 weeks post TKR
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Holland Orthopaedic & Arthritic Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: David Wasserstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Nwuga, G., & Nwuga, V. (1985). Relative therapeutic efficacy of the Williams and McKenzie protocols in back pain management. Physiotherapy practice, 1(2), 99-105.
citation: 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.
citation: Friedrich 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.
citation: Lam, 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.
citation: 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.
citation: Chkeir, 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.