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Clinical Trials/NCT03738384
NCT03738384CompletedNot Applicable

Knee Connect: Physiotherapy Exercise Performance With Visual Feedback After Total Knee Arthroplasty - Pilot Study

Sunnybrook Health Sciences Centre1 site in 1 country10 target enrollmentStarted: March 9, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Knee angle (degrees)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

TKR Patients

Experimental

Any patient 3-6 weeks post-op from a TKR

Intervention: Knee Connect + Visual Feedback System (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Peak knee flexion and extension angle (degrees)(One set of measurements 3-6 weeks post TKR)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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