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

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).

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Hip Osteoarthritis
• Intervention / Treatment: Device: Digital kinematic biofeedback system

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4250-449
    • Hospital da Prelada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: SWORD Phoenix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Timed up and Go Test score	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.	Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Collaborators: Hospital da Prelada
• Investigators: Principal Investigator: Fernando D Correia, MD, Sword Health, SA; Study Chair: Rosmaninho Seabra, MD, Hospital da Prelada

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2018
• Primary Completion (Actual): May 15, 2020
• Study Completion (Actual): May 15, 2020

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Osteoarthritis, Hip
• Other Study ID Numbers: SH-SA-TJR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Yes The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format.
• IPD Sharing Time Frame: Upon study publication, for at least five years.
• IPD Sharing Access Criteria: Study protocol will be made available here and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No