Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation

SWORD Health

Status: Completed

Conditions: Knee Osteoarthritis; Arthropathy of Knee

Treatments: Device: Home-based rehabilitation with a digital biofeedback system; Other: Conventional Home-based rehabilitation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03047252

SH-TKR-01

Details and patient eligibility

About

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.

Enrollment: 69 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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69 participants in 2 patient groups

Experimental group

Experimental group

Description:

Home-based rehabilitation sessions performed with the novel digital 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.

Treatment:

Device: Home-based rehabilitation with a digital biofeedback system

Conventional rehabilitation group

Active Comparator group

Description:

Home-based rehabilitation sessions provided by a Physical Therapist, 3 times a week for 8 weeks. Each session will have a duration of 60 minutes. Patients will be instructed to perform additional unsupervised sessions in at least two other days, but compliance to these extra sessions is not mandatory per protocol.

Treatment:

Other: Conventional Home-based rehabilitation