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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03648060
Recruitment Status : Completed
First Posted : August 27, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Hospital da Prelada
Information provided by (Responsible Party):
Sword Health, SA

Study Description
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Brief 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).


Condition or disease Intervention/treatment Phase
Hip Osteoarthritis Knee Osteoarthritis Device: Digital kinematic biofeedback system Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 8, 2018
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: SWORD Phoenix


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03648060


Locations
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Portugal
Hospital da Prelada
Porto, Portugal, 4250-449
Sponsors and Collaborators
Sword Health, SA
Hospital da Prelada
Investigators
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Principal Investigator: Fernando D Correia, MD Sword Health, SA
Study Chair: Rosmaninho Seabra, MD Hospital da Prelada
  Study Documents (Full-Text)

Documents provided by Sword Health, SA:
Study Protocol and Statistical Analysis Plan  [PDF] June 13, 2018

More Information
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Responsible Party: Sword Health, SA
ClinicalTrials.gov Identifier: NCT03648060    
Other Study ID Numbers: SH-SA-TJR-01
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Upon study publication, for at least five years.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Osteoarthritis, Hip
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases