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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Sword Health, SA
Sponsor:
Collaborator:
Hospital da Prelada
Information provided by (Responsible Party):
Sword Health, SA
ClinicalTrials.gov Identifier:
NCT03045549
First received: February 3, 2017
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
The study was designed to evaluate the effectiveness of a novel kinematic biofeedback system - SWORD Phoenix- in the rehabilitation after total hip replacement . SWORD Phoenix allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team. The investigators hypothesise 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 randomised controlled trial with active comparator. Patients will be enrolled and allocated 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. 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 terms of: a) range of motion of the hip joint (flexion/extension/abduction/adduction/internal and external rotation); b) Hip Osteoarthritis Outcome Score; c) quality of life, as measured by the SF-36 scale.

Condition Intervention
Hip Osteoarthritis
Hip Arthrosis
Device: SWORD Phoenix
Other: Traditional home-based rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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 Hip Replacement: a Pragmatic Clinical 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 weeks after surgery; 8 weeks 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 Hip injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline; 4 weeks after surgery; 8 weeks after surgery ]
    The HOOS is a standardized and validated patient outcome score that assesses functional limitation in patients with hip problems.

  • Change in the Short Form-36 Health Questionnaire (SF-36) [ Time Frame: Baseline; 4 weeks after surgery; 8 weeks after surgery ]
    The SF-36 is a widely used quality of life questionnaire

  • Change in the Range of Motion (degrees) [ Time Frame: Baseline; 4 weeks after surgery; 8 weeks after surgery ]
    Change in the hip range of motion (Flexion/extension/abduction/external and internal rotation) measured in degrees


Estimated Enrollment: 54
Actual Study Start Date: December 19, 2016
Estimated Study Completion Date: September 30, 2017
Estimated Primary Completion Date: August 30, 2017 (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 0-6) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and abductors (mainly) Ice pack application STAGE 2 (weeks 7-8) Open kinetic chain exercises with added resistance: lying, sitting (high chair) and standing (with progression to standing without support) Strengthening of hip flexors and abductors (mainly) Ice pack application after each session

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 0-6) Soft tissue massage Active assisted mobilization of the hip joint to increase range of motion (avoiding internal rotation and adduction) Gait training with bilateral assistive devices Isometric exercises progressing to open chain, low-impact, concentric exercises with strengthening of hip abductors and flexors Ice pack application STAGE 2 (weeks 7-8) Soft tissue massage Gait training with progressive withdrawal of assistive devices Balance exercises with progression to one-leg support Open-chain strengthening exercises against resistance with progression to closed-chain exercises Ice pack application


  Eligibility

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 hip osteoarthritis
  • Indication for total hip 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 hip 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03045549

Contacts
Contact: Fernando D Correia, MD 966557789 fcorreia@swordhealth.com

Locations
Portugal
Hospital da Prelada - Dr. Domingos Braga da Cruz Recruiting
Porto, Portugal, 4250-449
Contact: José R Seabra, MD    228 330 600      
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: NCT03045549     History of Changes
Other Study ID Numbers: RCT-THR-01
Study First Received: February 3, 2017
Last Updated: March 14, 2017
Individual Participant Data  
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, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 24, 2017