SWORD Phoenix Versus Standard of Care in the Rehabilitation After Total Knee Replacement
|ClinicalTrials.gov Identifier: NCT03047252|
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : October 24, 2017
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 or disease||Intervention/treatment|
|Knee Osteoarthritis Arthropathy of Knee||Device: SWORD Phoenix Other: Traditional Home-based rehabilitation|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Official Title:||Efficacy of Home-based Rehabilitation With SWORD Phoenix Versus Standard of Care After Total Knee Replacement: a Randomised Controlled Trial|
|Actual Study Start Date :||December 19, 2016|
|Estimated Primary Completion Date :||February 28, 2018|
|Estimated Study Completion Date :||May 31, 2018|
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
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03047252
|Contact: Fernando Correia||+351 firstname.lastname@example.org|
|Hospital da Prelada - Dr. Domingos Braga da Cruz||Recruiting|
|Porto, Portugal, 4250-449|
|Contact: José Seabra, MD + 351 228 330 770 email@example.com|
|Principal Investigator:||Fernando D Correia, MD||Sword Health, SA|