NCT03648060

Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement

Efficacy of a Home-based Rehabilitation Program Performed Through a Digital Kinematic Biofeedback System After Total Hip or Knee Replacement: a Single-arm, Prospective, Open-label Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Sword Health, SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement. This is a single-arm prospective study. Patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery. This program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist. Outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program. The primary outcome is the change in patient performance measure through the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) patient reported outcomes (Hip or Knee Osteoarthritis Outcome Score) and b) range of motion of the relevant joint (hip or knee).

Conditions

• Hip Osteoarthritis
• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	Digital kinematic biofeedback system	The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed by the therapist and edited according to patient evolution.

Timeline

• Start date: 2018-10-08
• Primary completion: 2020-05-15
• Completion: 2020-05-15
• First posted: 2018-08-27
• Last updated: 2020-10-22

Locations

1 site across 1 country: Portugal