NCT02914210

Brief Summary

The goals of this research study are the following:

  1. 1.To compare the effects of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy for total knee replacement (TKR) on 90-day health service use costs.
  2. 2.To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
  3. 3.To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

4 active sites

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

September 15, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 18, 2020

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

September 15, 2016

Results QC Date

December 13, 2019

Last Update Submit

October 26, 2021

Conditions

Total Knee Replacement

Keywords

TKRTKAKneeSurgeryReplacementRehabilitationVirtualPhysical TherapyTelerehabilitation

Outcome Measures

Primary Outcomes (1)

  • Cost Difference in US Dollars

    Difference in total health service use costs at 12-weeks postoperative between patients who receive tele-rehab-supported PT versus traditional home and/or clinic-based PT for TKR.

    12 weeks

Secondary Outcomes (6)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS)

    6 weeks and 12 weeks

  • Range of Motion

    6 weeks

  • 10-meter Gait Speed

    6 weeks

  • Pain Score

    12 weeks

  • Report of Falls

    12 weeks

  • +1 more secondary outcomes

Other Outcomes (7)

  • Knee Injury and Osteoarthritis Outcome Score (KOOS) Sub-domain Scores

    6 weeks and 12 weeks

  • Physical Activity

    6 weeks and 12 weeks

  • Return to Work

    6 weeks and 12 weeks

  • +4 more other outcomes

Study Arms (2)

Virtual physical therapy

OTHER

Virtual physical therapy rehabilitation program (VERA) used in the home with care planning and remote support and monitoring by physical therapists

Device: Virtual physical therapy rehabilitation program

Traditional physical therapy

OTHER

No intervention. Standard home health physical therapy and/or outpatient clinic physical therapy as prescribed.

Other: No intervention

Interventions

Virtual physical therapy rehabilitation programDEVICE

Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home

Virtual physical therapy
No interventionOTHER

Traditional physical therapy delivered in clinic or via home-health visits

Traditional physical therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 18 years of age
  • Scheduled to have a non-traumatic TKR
  • Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
  • Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization

You may not qualify if:

  • Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
  • Scheduled for staged bilateral TKR
  • Living in a nursing home prior to surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of North Carolina Orhthopedics

Chapel Hill, North Carolina, 27514, United States

Location

Duke Orthopaedics

Durham, North Carolina, 27705, United States

Location

Greensboro Orthopedics

Greensboro, North Carolina, 27408, United States

Location

Raleigh Orthopaedics

Raleigh, North Carolina, 27612, United States

Location

Results Point of Contact

Title
Janet Bettger, ScD
Organization
Duke Clinical Research Institute
janet.bettger@duke.edu
919-613-0379

Study Officials

  • Janet Bettger, ScD

    Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2016

First Posted

September 26, 2016

Study Start

October 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

November 2, 2021

Results First Posted

January 18, 2020

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(4)