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Completed

NCT Number: NCT03648060

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).

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Key information

Conditions

Hip Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital da Prelada

Porto, 4250-449, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital kinematic biofeedback system

Device

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.

Other names: SWORD Phoenix

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Sword Health, SA

Industry

Collaborators

  • Hospital da Prelada

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 27, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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