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

Primary Purpose

Hip Osteoarthritis, Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Digital kinematic biofeedback system
Sponsored by
Sword Health, SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hip Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital da Prelada

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Change in Hip/Knee Range of Motion
This will be measured (in degrees) automatically by the device

Full Information

First Posted
August 23, 2018
Last Updated
October 20, 2020
Sponsor
Sword Health, SA
Collaborators
Hospital da Prelada
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1. Study Identification

Unique Protocol Identification Number
NCT03648060
Brief Title
Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2018 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sword Health, SA
Collaborators
Hospital da Prelada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Osteoarthritis, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Digital kinematic biofeedback system
Other Intervention Name(s)
SWORD Phoenix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Timed up and Go Test score
Description
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.
Time Frame
Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Secondary Outcome Measure Information:
Title
Change in the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score
Description
The HOOS/KOOS are standardized and validated patient outcome scores that assess functional limitation in patient with hip/knee osteoarthritis
Time Frame
Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Title
Change in Hip/Knee Range of Motion
Description
This will be measured (in degrees) automatically by the device
Time Frame
Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando D Correia, MD
Organizational Affiliation
Sword Health, SA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosmaninho Seabra, MD
Organizational Affiliation
Hospital da Prelada
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital da Prelada
City
Porto
ZIP/Postal Code
4250-449
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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