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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03648060
• Other study ID #: SH-SA-TJR-01
• Status: Completed
• Phase: N/A
• Start date: October 8, 2018
• Est. completion date: May 15, 2020

Study information

• Verified date: March 2020
• Source: Sword Health, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 15, 2020
• Est. primary completion date: May 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Osteoarthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Hip
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
Portugal	Hospital da Prelada	Porto

Sponsors (2)

Lead Sponsor	Collaborator
Sword Health, SA	Hospital da Prelada

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)