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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rehabilitation with InterACTION

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

Group Type EXPERIMENTAL

InterACTION

Intervention Type DEVICE

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

Standard Physical Therapy

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

Group Type OTHER

Standard of Care Physical Therapy

Intervention Type OTHER

Physical therapy rehabilitation program

Interventions

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InterACTION

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

Intervention Type DEVICE

Standard of Care Physical Therapy

Physical therapy rehabilitation program

Intervention Type OTHER

Eligibility Criteria

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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;

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No