Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital da Prelada | OTHER |
Not provided
Not provided
Not provided
Not provided
The study was designed to test patient acceptance and system usability and to assess clinical outcomes of a home-based rehabilitation program using a novel kinematic biofeedback system in the rehabilitation after total knee replacement versus conventional rehabilitation, This system allows the patients to perform independent rehabilitation sessions at home, under remote monitoring from the clinical team.
The investigators hypothesize that the system will be well received by patients and that the clinical outcomes will be at least similar those of conventional rehabilitation.
This is a quasi-randomized controlled trial with active comparator. Patients will be enrolled pre-operatively and divided into 2 groups: experimental group and conventional rehabilitation group according to geographical criteria. 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.
The following feasibility outcomes will be registered: enrollment rate, retention rate (drop-outs), compliance to the program, independence of use, need for therapist contact and patient satisfaction.
Clinical outcomes will be measured at weeks 4 and 8 and then at 3 and 6 months. The primary outcome will be measured in terms of patient 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Conventional rehabilitation group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based rehabilitation with a digital biofeedback system | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Timed up And Go Test score | 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. | Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee injury and Osteoarthritis Outcome Score (KOOS) | The KOOS is a standardized and validated patient outcome score that assesses functional limitation in patient with knee problems. | Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery |
| Change in Knee Range of Motion (degrees) |
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | This will be measured through the percentage of patients that actually enroll in the study after initial screening. | At the end of patient enrollment- up to 18 months after trial initiation |
| Retention rate |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD | Sword Health, SA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Prelada - Dr. Domingos Braga da Cruz | Porto | 4250-449 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30816849 | Derived | Correia FD, Nogueira A, Magalhaes I, Guimaraes J, Moreira M, Barradas I, Molinos M, Teixeira L, Tulha J, Seabra R, Lains J, Bento V. Medium-Term Outcomes of Digital Versus Conventional Home-Based Rehabilitation After Total Knee Arthroplasty: Prospective, Parallel-Group Feasibility Study. JMIR Rehabil Assist Technol. 2019 Feb 28;6(1):e13111. doi: 10.2196/13111. |
Not provided
Not provided
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
Upon study publication, for at least five years.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
All patients will be assessed for clinical outcomes by an independent rater blinded to the study arm
|
|
| Conventional Home-based rehabilitation | Other | 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 knee flexion/extension measured in degrees |
| Baseline; 4 and 8 weeks after initiation of rehabilitation program and then at 3 and 6 months after surgery |
This will be assessed through the percentage of patients in the experimental group that complete the 8-week program
| At week 8 |
| Independence of use | This will be assessed through the percentage of patients in the experimental group that require the assistance of a caregiver in interacting with the system. | For each patient, at week 8 or upon dropout. |
| Compliance | This will be measured by calculating the percentage of patients allocated to the experimental group that performed at least 5 weekly sessions throughout the program | For each patient, at week 8. |
| Patient Satisfaction | This will be measured in the experimental group by answering the following question: "On a scale from 0 to 10, how likely are you to recommend this intervention to a friend or neighbour?". Scores of 9 and 10 will be considered "good", 7 and 8 "neutral" and less than 7 "bad". | At week 8 or upon dropout. |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided