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

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ClinicalTrials.gov Identifier: NCT03047252
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
Hospital da Prelada
Information provided by (Responsible Party):
Sword Health, SA

Brief Summary:

The study was designed to compare the outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement.

This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.

The investigators hypothesize that the clinical outcomes of a home-based rehabilitation program will be at least similar to the outcomes of a traditional home-based rehabilitation with face-to-face sessions.

This is a randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group. 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.

Outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome is the change in 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 (flexion/extension);


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Arthropathy of Knee Device: Home-based rehabilitation with a digital biofeedback system Other: Conventional Home-based rehabilitation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: All patients will be assessed for clinical outcomes by an independent rater blinded to the study arm
Primary Purpose: Treatment
Official Title: Home-based Rehabilitation With A Novel Digital Biofeedback System Versus Conventional Rehabilitation After Total Knee Replacement: a Randomized Controlled Study
Actual Study Start Date : December 19, 2016
Actual Primary Completion Date : May 27, 2018
Actual Study Completion Date : May 27, 2018

Resource links provided by the National Library of Medicine


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 Name: 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





Primary Outcome Measures :
  1. Change in the Timed up And Go Test score [ Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery ]
    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.


Secondary Outcome Measures :
  1. Change in Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery ]
    The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems.

  2. Change in Knee Range of Motion (degrees) [ Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery ]
    Change in knee flexion/extension measured in degrees



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047252


Locations
Portugal
Hospital da Prelada - Dr. Domingos Braga da Cruz
Porto, Portugal, 4250-449
Sponsors and Collaborators
Sword Health, SA
Hospital da Prelada
Investigators
Principal Investigator: Fernando D Correia, MD Sword Health, SA

Additional Information:
Responsible Party: Sword Health, SA
ClinicalTrials.gov Identifier: NCT03047252     History of Changes
Other Study ID Numbers: RCT-TKR-01
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Menthol
Antipruritics
Dermatologic Agents