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

NCT03648060 | Completed

• 1 other identifier: SH-SA-TJR-01
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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).

Conditions

Hip Osteoarthritis; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score

  Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)

• Change in Hip/Knee Range of Motion

  Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)

Study Arms (1)

Experimental group

EXPERIMENTAL

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

Interventions

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.

Also known as: SWORD Phoenix

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sword Health, SA: lead
• Hospital da Prelada: collaborator

Study Sites (1)

Hospital da Prelada

Porto, 4250-449, Portugal

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Fernando D Correia, MD

  Sword Health, SA

  PRINCIPAL INVESTIGATOR

• Rosmaninho Seabra, MD

  Hospital da Prelada

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 27, 2018
• Study Start: October 8, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

PT (1)