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

NCT03047252 | Completed

• 1 other identifier: SH-TKR-01
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Arthropathy of Knee

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Knee injury and Osteoarthritis Outcome Score (KOOS)

  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)

  Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery

Other Outcomes (5)

• Enrollment rate

  At the end of patient enrollment- up to 18 months after trial initiation

• Retention rate

  At week 8

• Independence of use

  For each patient, at week 8 or upon dropout.

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Conventional rehabilitation group

ACTIVE COMPARATOR

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

Interventions

Home-based rehabilitation with a digital biofeedback system DEVICE

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

Also known as: SWORD Phoenix

Experimental group

Conventional Home-based rehabilitation OTHER

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

Conventional rehabilitation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sword Health, SA: lead
• Hospital da Prelada: collaborator

Study Sites (1)

Hospital da Prelada - Dr. Domingos Braga da Cruz

Porto, 4250-449, Portugal

Location

Related Publications (1)

• 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.

  PMID: 30816849 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Fernando D Correia, MD

  Sword Health, SA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All patients will be assessed for clinical outcomes by an independent rater blinded to the study arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 8, 2017
• Study Start: December 19, 2016
• Primary Completion: May 27, 2018
• Study Completion: May 27, 2018
• Last Updated: February 6, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon study publication, for at least five years.
• 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.

Locations

PT (1)