Rehabilitation for Total Knee Replacement: a Novel Biofeedback System Versus Conventional Home-based Rehabilitation
|ClinicalTrials.gov Identifier: NCT03047252|
Recruitment Status : Completed
First Posted : February 8, 2017
Last Update Posted : June 8, 2018
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|
|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:||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|
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
- 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 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
|Hospital da Prelada - Dr. Domingos Braga da Cruz|
|Porto, Portugal, 4250-449|
|Principal Investigator:||Fernando D Correia, MD||Sword Health, SA|