N/A
N=38
interACTION: A Portable Joint Function Monitoring and Training System for Remote Rehabilitation Following TKA
Total Knee Arthroplasty
Bottom Line
View on ClinicalTrials.gov: NCT02646761 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcome: Primary: Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. — 0.013; 0.018 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- InterACTION (Device); Standard of Care Physical Therapy (Other)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- James J. Irrgang
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Value Was Evaluated as the Ratio of Change in the Activities of Daily Living Scale Score to the Costs of Rehabilitation. |
0.013; 0.018 | — |
| SECONDARY Number of Participants That Complied With Rehabilitation Program |
6; 5; 4; 2; 0; 0 | — |
| SECONDARY Number of Subjects Satisfied With InterACTION Device |
11; 0 | — |
| SECONDARY Performance Based Outcome Measures |
-0.0071; 0.028 | — |
| SECONDARY Range of Motion (Extension) |
5.3; 1.1; 1.6; 1.7 | — |
| SECONDARY Range of Motion (Flexion) |
93.0; 91.5; 120.8; 123.1 | — |
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.
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;
Data sourced from ClinicalTrials.gov (NCT02646761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.