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SWORD Phoenix Versus Standard of Care in the Rehabilitation After Total Knee Replacement

This study is currently recruiting participants.
Verified October 2017 by Sword Health, SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT03047252
First Posted: February 8, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Hospital da Prelada
Information provided by (Responsible Party):
Sword Health, SA
  Purpose

The study was designed to evaluate the effectiveness of a novel kinematic biofeedback system - SWORD Phoenix- in the rehabilitation after total knee replacement .

SWORD Phoenix 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 and randomized pre-operatively into 2 groups: intervention group and control group. Both groups will perform 8 weeks of rehabilitation starting on day 7 after surgery.

The intervention group will perform daily rehabilitation sessions at home using SWORD Phoenix, under remote monitoring from a physical therapist. The control 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 performance in the Timed-up-and-Go (TUG) test between in each patient in comparison with the pre-operative score. Secondary outcomes will be measured in term of: a) range of motion of the knee joint (flexion/extension); b) Knee Osteoarthritis Outcome Score); c) quality of life, as measured by the SF-36 scale.


Condition Intervention
Knee Osteoarthritis Arthropathy of Knee Device: SWORD Phoenix Other: Traditional Home-based rehabilitation

Study Type: Interventional
Study Design: 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: Efficacy of Home-based Rehabilitation With SWORD Phoenix Versus Standard of Care After Total Knee Replacement: a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Sword Health, SA:

Primary Outcome Measures:
  • 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:
  • 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.

  • Change in the Short-Form 36 Health Questionnaire [ Time Frame: Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery ]
    The SF-36 is a widely used quality of life questionnaire

  • 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


Estimated Enrollment: 60
Actual Study Start Date: December 19, 2016
Estimated Study Completion Date: May 31, 2018
Estimated Primary Completion Date: February 28, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rehabilitation using SWORD Phoenix
Home-based rehabilitation sessions performed with SWORD Phoenix.
Device: SWORD Phoenix

SWORD Phoenix 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: Smart Wearable Operative Rehabilitation Device
Active Comparator: Traditional home-based rehabilitation
Home-based rehabilitation sessions provided by a Physical Therapist.
Other: Traditional 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


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 7 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
  Contacts and Locations
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


Contacts
Contact: Fernando Correia +351 966557789 fcorreia@swordhealth.com

Locations
Portugal
Hospital da Prelada - Dr. Domingos Braga da Cruz Recruiting
Porto, Portugal, 4250-449
Contact: José Seabra, MD    + 351 228 330 770    centro.atendimento@hospitaldaprelada.pt   
Sponsors and Collaborators
Sword Health, SA
Hospital da Prelada
Investigators
Principal Investigator: Fernando D Correia, MD Sword Health, SA
  More Information

Additional Information:
Responsible Party: Sword Health, SA
ClinicalTrials.gov Identifier: NCT03047252     History of Changes
Other Study ID Numbers: RCT-TKR-01
First Submitted: February 3, 2017
First Posted: February 8, 2017
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data will not be made available to other researchers

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