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

Overview

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).

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Experimental group
    • Home-based rehabilitation sessions performed with the digital kinematic biofeedback system. Patients will be instructed to perform exercise sessions in at least 5 days per week, but compliance to this schedule is not mandatory per protocol.

Clinical Trial Outcome Measures

Primary Measures

  • Change in the Timed up and Go Test score
    • Time Frame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
    • The timed up and go requires a patient to rise from a chair walk three meters around a piece of tape and return to the chair again as quickly as possible.

Secondary Measures

  • Change in the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score
    • Time Frame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
    • The HOOS/KOOS are standardized and validated patient outcome scores that assess functional limitation in patient with hip/knee osteoarthritis
  • Change in Hip/Knee Range of Motion
    • Time Frame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
    • This will be measured (in degrees) automatically by the device

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical and imaging evidence of hip/knee osteoarthritis
  • Indication for total hip/knee replacement according to the patient´s orthopedic surgeon
  • Ability to walk unaided, with unilateral or bilateral support
  • Availability of a carer to assist the patient after surgery

Exclusion Criteria

  • Patients admitted for revision of total hip/knee replacement
  • Contralateral hip or knee osteoarthritis severely limiting patient mobility and ability to comply with a rehabilitation program
  • Aphasia, dementia or psychiatric comorbidity interfering with the communication or compliance to the rehabilitation process
  • Respiratory, cardiac, metabolic or other condition incompatible with at least 30 minutes of light to moderate physical activity
  • Major medical complications occurring after surgery that prevent the discharge of the patient within 10 days after the surgery
  • Other medical and/or surgical complications that prevent the patient from complying with a rehabilitation program
  • Blind and/or illiterate patients

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sword Health, SA
  • Collaborator
    • Hospital da Prelada
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Fernando D Correia, MD, Principal Investigator, Sword Health, SA
    • Rosmaninho Seabra, MD, Study Chair, Hospital da Prelada
  • Overall Contact(s)
    • Fernando D Correia, MD, 966557789, fcorreia@swordhealth.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.