Study of the KinexConnect Telerehabilitation System (KCTRS)

Kinex Medical Company

Status: Active, not recruiting

Conditions: Osteoarthritis, Knee

Treatments: Behavioral: Traditional outpatient PT for rehabilitation after TKA.; Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04191798

KC-07

Details and patient eligibility

About

A randomized, single-blind study comparing telerehabilitation at home with continuous passive motion (CPM) and a tablet-based patient engagement application (KinexConnect) versus traditional outpatient physical therapy (PT) following total knee arthroplasty (TKA).

Full description

The Randomized Study of the KinexConnect Telerehabilitation System is a 1:1 randomized, single-blind, prospective cohort study to be conducted at one investigational site in the United States. The study compares at-home telerehabilitation system versus traditional outpatient PT following total knee arthroplasty (TKA). The telerehabilitation system involves a tablet-enabled patient engagement application, the KinexConnect App, to be used in conjunction with a continuous passive motion (CPM) machine.

Enrollment: 60 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Planned for a primary unilateral TKA.
2. At least 21 years of age.
3. Capable of understanding the study requirements and giving written informed consent.
4. Willing and able to comply with either therapy program.
5. Has easy access to caregiver support.

Exclusion criteria

1. Active range-of-motion (ARoM) < 80 degrees in target knee.
2. Unable to read and write in English.
3. Lack of email capability to receive recovery trend information.
4. Previous knee intervention in target knee.
5. Previous knee joint infection in either knee.
6. Received a revision TKA (opposite knee).
7. Planned for bilateral TKA.
8. Self-reported pregnancy.
9. Reason for arthroplasty being for the treatment of fracture, infection or malignancy.
10. Other physical or mental impairments or medical conditions that may affect ability to complete therapy as prescribed.
11. Unwilling to participate.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

KinexConnect

Experimental group

Description:

Rehab at Home Patients

Treatment:

Behavioral: Telerehabilitation using the KinexConnect system for rehabilitation after TKA.

Outpatient PT

Active Comparator group

Description:

In-person PT patients

Treatment:

Behavioral: Traditional outpatient PT for rehabilitation after TKA.