NCT02646761

Brief Summary

The purpose of this study is to determine if home-based therapy with monitoring via telemedicine can overcome many barriers to compliance and improve rehabilitation. Patients undergoing total knee arthroplasty will be followed for 10 weeks during their outpatient physical therapy course. Subjects will undergo standard physical therapy or physical therapy paired with InterACTION for 10 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

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

August 14, 2015

Completed
5 months until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

February 5, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

August 14, 2015

Results QC Date

December 20, 2018

Last Update Submit

January 14, 2019

Conditions

Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.

    The value was calculated the ratio of the difference between the 10 week and baseline Activities of Daily Living Scale (ADLS) of the Knee Outcome Survey divided by the total charges for the physical therapy treatment sessions. The ADLS is a 14-item measure of symptoms and activity limitations for individuals with a variety of knee impairments. Items are scored from 0 to 4, and the total score is the sum of all the items divided by 70 and multiplied by 100. The ADLS score ranges from 0 to 100 with higher scores representing less symptoms and greater levels of activity. Higher ratio of the change in the ADLS score to the costs for rehabilitation represents greater value.

    10 weeks

Secondary Outcomes (5)

  • Number of Participants That Complied With Rehabilitation Program

    10 weeks

  • Number of Subjects Satisfied With InterACTION Device

    10 weeks

  • Performance Based Outcome Measures

    10 weeks

  • Range of Motion (Extension)

    baseline and 10 weeks

  • Range of Motion (Flexion)

    baseline and 10 weeks

Study Arms (2)

Rehabilitation with InterACTION

EXPERIMENTAL

After total knee arthroplasty, subjects will undergo physical therapy 1 time per week supplemented by home exercise program with InterACTION device.

Device: InterACTION

Standard Physical Therapy

OTHER

After total knee arthroplasty, subjects will undergo standard of care physical therapy 2 times per week with standard home exercise program.

Other: Standard of Care Physical Therapy

Interventions

InterACTIONDEVICE

InterACTION guided home exercise program paired with standard of care physical therapy

Rehabilitation with InterACTION
Standard of Care Physical TherapyOTHER

Physical therapy rehabilitation program

Standard Physical Therapy

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between ages 40 to 80 years of age;
  • Have undergone primary unilateral total knee arthroplasty;
  • Being referred for post-operative outpatient physical therapy;
  • Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.

You may not qualify if:

  • Patients with BMI \>40 at the time of surgery;
  • Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;
  • Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;
  • Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Bell KM, Onyeukwu C, Smith CN, Oh A, Devito Dabbs A, Piva SR, Popchak AJ, Lynch AD, Irrgang JJ, McClincy MP. A Portable System for Remote Rehabilitation Following a Total Knee Replacement: A Pilot Randomized Controlled Clinical Study. Sensors (Basel). 2020 Oct 27;20(21):6118. doi: 10.3390/s20216118.

    PMID: 33121204DERIVED

Results Point of Contact

Title
Dr. James J. Irrgang
Organization
University of Pittsburgh
jirrgang@pitt.edu
(412) 383-9865

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD, PT

Study Record Dates

First Submitted

August 14, 2015

First Posted

January 6, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 5, 2019

Results First Posted

February 5, 2019

Record last verified: 2019-01

Locations

US(1)