NCT03738384

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed
1.3 years until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

July 12, 2024

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

October 26, 2018

Last Update Submit

July 10, 2024

Conditions

ArthroplastyReplacementKnee

Keywords

Rehabilitation, Visual, Feedback

Outcome Measures

Primary Outcomes (2)

  • Knee angle (degrees)

    The difference in measured knee angle with and without visual feedback.

    One set of measurements 3-6 weeks post TKR

  • Knee velocity (degrees/s)

    The difference in measured knee velocity with and without visual feedback.

    One set of measurements 3-6 weeks post TKR

Secondary Outcomes (1)

  • Peak knee flexion and extension angle (degrees)

    One set of measurements 3-6 weeks post TKR

Study Arms (1)

TKR Patients

EXPERIMENTAL

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

Device: Knee Connect + Visual Feedback System

Interventions

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.

TKR Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Be enrolled in the "Knee Class" postoperative physiotherapy
  • Be able to provide informed consent
  • weeks post-operative from primary total knee replacement surgery

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Holland Orthopaedic & Arthritic Centre

Toronto, Ontario, M4Y 1H1, Canada

Location

Related Publications (7)

  • 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.

    PMID: 2904582BACKGROUND

  • Nwuga, G., & Nwuga, V. (1985). Relative therapeutic efficacy of the Williams and McKenzie protocols in back pain management. Physiotherapy practice, 1(2), 99-105.

    BACKGROUND

  • 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.

    PMID: 2149211BACKGROUND

  • 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.

    PMID: 8863761BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 25570311BACKGROUND

  • 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.

    BACKGROUND

Study Officials

  • David Wasserstein, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2018

First Posted

November 13, 2018

Study Start

March 9, 2020

Primary Completion

September 22, 2022

Study Completion

September 28, 2022

Last Updated

July 12, 2024

Record last verified: 2021-03

Locations

CA(1)