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

Total Knee Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646761
• Other study ID #: PRO15060281
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2019
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Between ages 40 to 80 years of age;

2. Have undergone primary unilateral total knee arthroplasty;

3. Being referred for post-operative outpatient physical therapy;

4. Agree to and able to perform pre-defined exercises that they would normally perform in a physical rehabilitation program.

Exclusion Criteria:

1. Patients with BMI >40 at the time of surgery;

2. Individuals who are not free of any other co-disability or comorbidity that would specifically impede disallow or otherwise hinder performance of rehabilitation exercises;

3. Individuals who cannot physically receive or understand audio and visual feedback from the joint motion tracking system during or after performance of rehabilitation exercises;

4. Individuals who are discharged post-operatively to a skilled nursing facility instead of to their residence;

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

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

Other:
• Standard of Care Physical Therapy
Physical therapy rehabilitation program

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
James J. Irrgang

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants That Complied With Rehabilitation Program	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.	10 weeks
Secondary	Number of Subjects Satisfied With InterACTION Device	Subjects in the interACTION group were asked "Would you consider using the InterACTION device if you had to do rehabilitation again in the future?"	10 weeks
Secondary	Performance Based Outcome Measures	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.	10 weeks
Secondary	Range of Motion (Extension)	Extension of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.	baseline and 10 weeks
Secondary	Range of Motion (Flexion)	Flexion of both knees was measured with a goniometer and the side-to-side difference was expressed in degrees.	baseline and 10 weeks