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Virtual vs. Traditional Physical Therapy Following Total Knee Replacement

NCT ID: NCT02914210

Last Updated: 2021-11-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-03-31

Brief Summary

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The goals of this research study are the following:

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. To compare tele-rehabilitation-supported physical therapy and traditional physical therapy on patient-centered outcomes
3. To explore whether individual patient characteristics are associated with differential improvement from 6 to 12 weeks assessed by patient-reported outcomes.

Detailed Description

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This study will compare the effects on health service use costs of tele-rehabilitation-supported physical therapy versus traditional home and/or clinic-based physical therapy following total knee replacement (TKR) surgery. It will also examine standard post-surgical clinical measures to confirm non-inferiority of outcomes between groups. A total of 300 patients will receive standard pre- and post-surgical medical care from their healthcare providers, and be randomized to receive pre-surgery rehabilitation exercises ("pre-hab") and post-discharge physical therapy provided via either a home-based tele-rehabilitation platform (intervention group, n=150) or home-health and clinic-based physical therapy regimen (control group, n=150). Data will be collected by sites at enrollment, baseline, hospital discharge, and 6 weeks following surgery. Patients will complete telephone surveys regarding their health and knee function at baseline, 6 weeks, and 3 months after surgery. Patients will also keep a diary from hospital discharge through 3 months documenting healthcare utilization and progress toward a personal recovery goal. Diary information will be collected over the phone concurrently with administration of the 6-week and 3-month surveys. The episode for analysis will be from surgery through 3 months post-discharge, in alignment with the Centers for Medicare and Medicaid Services Comprehensive Care for Joint Replacement (CJR) bundled payment model. Physical risks or benefits to patients for participating in this study are as expected from standard pre- and post-surgical physical therapy associated with total knee replacement surgery. The low risk of loss of confidentiality for all subjects will be minimized using appropriate safeguards.

Conditions

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Total Knee Replacement

Keywords

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TKR TKA Knee Surgery Replacement Rehabilitation Virtual Physical Therapy Telerehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Virtual physical therapy

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

Group Type OTHER

Virtual physical therapy rehabilitation program

Intervention Type DEVICE

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

Traditional physical therapy

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

Group Type OTHER

No intervention

Intervention Type OTHER

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

Interventions

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Virtual physical therapy rehabilitation program

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

Intervention Type DEVICE

No intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. ≥ 18 years of age
2. Scheduled to have a non-traumatic TKR
3. Can be enrolled a minimum of 10 days prior to surgery (in-person visit)
4. Have a Risk Assessment and Prediction Tool (RAPT) score of ≥ 6 indicating expected discharge home after surgical hospitalization

Exclusion Criteria

1. Unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (comprehension)
2. Scheduled for staged bilateral TKR
3. Living in a nursing home prior to surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reflexion Health, Inc.

INDUSTRY

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet Bettger, ScD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute, Duke Dept of Orthopaedic Surgery

Locations

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University of North Carolina Orhthopedics

Chapel Hill, North Carolina, United States

Site Status

Duke Orthopaedics

Durham, North Carolina, United States

Site Status

Greensboro Orthopedics

Greensboro, North Carolina, United States

Site Status

Raleigh Orthopaedics

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Pro00074409

Identifier Type: -

Identifier Source: org_study_id