Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement
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|ClinicalTrials.gov Identifier: NCT03648060|
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : March 24, 2020
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||June 2020|
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
- 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.
- 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
- 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
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
|Contact: Fernando D Correia, MDemail@example.com|
|Hospital da Prelada||Recruiting|
|Porto, Portugal, 4250-449|
|Contact: Rosmaninho Seabra + 351 228 330 770 firstname.lastname@example.org|
|Principal Investigator:||Fernando D Correia, MD||Sword Health, SA|
|Study Chair:||Rosmaninho Seabra, MD||Hospital da Prelada|