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

Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis; Arthropathy of Knee
• Intervention / Treatment: Device: Home-based rehabilitation with a digital biofeedback system; Other: Conventional Home-based rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4250-449
    • Hospital da Prelada - Dr. Domingos Braga da Cruz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Device: Home-based rehabilitation with a digital biofeedback system; The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed, based on the following principles: STAGE 1 (Weeks 0-2) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and extensors Ice pack application after each session and throughout the day as needed STAGE 2 (weeks 3-6) Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors and extensors and knee stabilization Progression to standing exercises without support lying, sitting and standing (with support) Exercises with steps Ice pack application after each session and throughout the day as needed STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Multi-directional exercises; Other Names: SWORD Phoenix
Active Comparator: Conventional rehabilitation group; 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.	Other: Conventional Home-based rehabilitation; Patients will perform 3 weekly rehabilitation sessions, with a duration of 1 hour, for 8 weeks, provided by a physical therapist. The rehabilitation program will respect the following principles: STAGE 1 (Weeks 0-2) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Gait training with bilateral support Open kinetic chain exercises without added resistance Strengthening of hip flexors and extensors Ice pack application STAGE 2 (weeks 3-6) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors/ extensors and knee stabilisation Gait training with progressive withdrawal of external support Ice pack application STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Weight-bearing exercises on uneven surfaces Ice pack application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Timed up And Go Test score	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.	Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee injury and Osteoarthritis Outcome Score (KOOS)	The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.	Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery
Change in Knee Range of Motion (degrees)	Change in knee flexion/extension measured in degrees	Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	This will be measured through the percentage of patients that actually enroll in the study after initial screening.	At the end of patient enrollment- up to 18 months after trial initiation
Retention rate	This will be assessed through the percentage of patients in the experimental group that complete the 8-week program	At week 8
Independence of use	This will be assessed through the percentage of patients in the experimental group that require the assistance of a caregiver in interacting with the system.	For each patient, at week 8 or upon dropout.
Compliance	This will be measured by calculating the percentage of patients allocated to the experimental group that performed at least 5 weekly sessions throughout the program	For each patient, at week 8.
Patient Satisfaction	This will be measured in the experimental group by answering the following question: "On a scale from 0 to 10, how likely are you to recommend this intervention to a friend or neighbour?". Scores of 9 and 10 will be considered "good", 7 and 8 "neutral" and less than 7 "bad".	At week 8 or upon dropout.

Collaborators and Investigators

• Sponsor: Sword Health, SA
• Collaborators: Hospital da Prelada
• Investigators: Principal Investigator: Fernando D Correia, MD, Sword Health, SA

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study Protocol

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2016
• Primary Completion (Actual): May 27, 2018
• Study Completion (Actual): May 27, 2018

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 2, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
• Other Study ID Numbers: SH-TKR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The study protocol will be made available in PDF format. Aggregate study results, with anonymised individual participant data will be made available in Excel format
• IPD Sharing Time Frame: Upon study publication, for at least five years.
• IPD Sharing Access Criteria: Study protocol is already available in clinicaltrials.gov and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No