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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Change in the Timed up and Go Test score
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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))