ClinicalTrials.Veeva

Menu

Study of the KinexConnect Telerehabilitation System (KCTRS)

K

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

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

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.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems