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Clinical Trials/NCT02646761
NCT02646761
Completed
N/A

interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following Total Knee Arthroplasty

James J. Irrgang1 site in 1 country38 target enrollmentApril 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Total Knee Arthroplasty
Sponsor
James J. Irrgang
Enrollment
38
Locations
1
Primary Endpoint
Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation.
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
December 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
James J. Irrgang
Responsible Party
Sponsor Investigator
Principal Investigator

James J. Irrgang

PhD, PT

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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;

Outcomes

Primary Outcomes

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

Time Frame: 10 weeks

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.

Secondary Outcomes

  • 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 Sites (1)

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