Clinical trial NCT03047252: Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation
Official title: Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthropathy of Knee
Lead sponsor: Sword Health, SA
Sponsor class: INDUSTRY
Collaborators: name: Hospital da Prelada
First posted: 2017-02-08
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.

The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.

This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. Both groups will perform 8 weeks of rehabilitation starting between day 7 and 10 after surgery.

The experimental group will perform daily rehabilitation sessions at home using the system, under remote monitoring from a physical therapist. The conventional rehabilitation group will perform 1h rehabilitation sessions 3 times a week, at home, given by a physical therapist.

The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.

Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient performance in the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: b) Knee Osteoarthritis Outcome Score); c) range of motion of the knee joint.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old
* Clinical and imaging evidence of knee osteoarthritis
* Indication for total 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 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 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Secondary outcomes:
measure: Change in Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
measure: Change in Knee Range of Motion (degrees)
timeFrame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Other outcomes:
measure: Enrollment rate
timeFrame: At the end of patient enrollment- up to 18 months after trial initiation
measure: Retention rate
timeFrame: At week 8
measure: Independence of use
timeFrame: For each patient, at week 8 or upon dropout.
measure: Compliance
timeFrame: For each patient, at week 8.
measure: Patient Satisfaction
timeFrame: At week 8 or upon dropout.
Locations:
city: Porto
country: Portugal
facility: Hospital da Prelada - Dr. Domingos Braga da Cruz
Study officials:
affiliation: Sword Health, SA
name: Fernando D Correia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111.