Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement
- Conditions
- Hip OsteoarthritisKnee Osteoarthritis
- Interventions
- Device: Digital kinematic biofeedback system
- Registration Number
- NCT03648060
- Lead Sponsor
- Sword Health, SA
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 88
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental group Digital kinematic biofeedback system 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.
- Primary Outcome Measures
Name Time Method Change in the Timed up and Go Test score 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
Name Time Method 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) 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 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
Trial Locations
- Locations (1)
Hospital da Prelada
🇵🇹Porto, Portugal