Skip to main content
OpenTrials
Completed

NCT Number: NCT02646761

interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Total Knee Arthroplasty

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

InterACTION

Device

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

Standard of care physical therapy

Other

Physical therapy rehabilitation program

Primary outcomes

  1. 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

  1. Number of Participants That Complied With Rehabilitation Program

    Time frame: 10 weeks

    Compliance with the use of the InterACTION device was measured by reports generated from the device. Subjects in the Standard Physical Therapy Group completed exercise logs that were monitored at each study visit.

  2. Number of Subjects Satisfied With InterACTION Device

    Time frame: 10 weeks

    Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"

  3. Performance Based Outcome Measures

    Time frame: 10 weeks

    The performance based measures included the 6-minute walk test (measured as distance in meters); stair climb test (measured as time in seconds divided by the number of steps); timed up and go test (measured in seconds); and unilateral balance test (measured in seconds). To combine the 4 performance-based outcome measures into a single composite score, the score for each test was converted to a z score (individual's score - overall mean)/overall standard deviation. As such, the z-score represents the number of SD deviations an individual's score is above or below the overall study mean. A z-score of 0 implies the participants score is the same as the mean score. A z-score of 0.1 would indicate that the participant's z score is .1 (10%) of a standard deviation above or below the overall mean. The average of the z scores for each performance-based outcome measure as the unit of analysis.

  4. Range of Motion (Extension)

    Time frame: baseline and 10 weeks

    Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.

  5. Range of Motion (Flexion)

    Time frame: baseline and 10 weeks

    Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.

Sponsors and collaborators

Lead sponsor

James J. Irrgang

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2016
Registry last updated
Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.