Clinical trial NCT03648060: Efficacy of a Digital Biofeedback System for Home-based Rehabilitation After Total Joint Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital da Prelada
First posted: 2018-08-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Timed up and Go Test score
timeFrame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Secondary outcomes:
measure: Change in the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score
timeFrame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
measure: Change in Hip/Knee Range of Motion
timeFrame: Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8)
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Hospital da Prelada
Study officials:
affiliation: Sword Health, SA
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital da Prelada
name: Rosmaninho Seabra, MD
role: STUDY_CHAIR
References: