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


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
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2020


  • 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

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