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| Name | Class |
|---|---|
| Hospital da Prelada | OTHER |
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The study was designed to assess the efficacy of a home-based rehabilitation program using a digital kinematic biofeedback system after total hip or knee replacement.
This is a single-arm prospective study. Patients will be enrolled pre-operatively and will perform an 8-week rehabilitation program starting between day 7 and 10 after surgery.
This program will consist of rehabilitation sessions performed independently by the patient at under remote monitoring from a physical therapist.
Outcomes will be measured at baseline, 4 weeks into the rehabilitation program and at the end of the program.
The primary outcome is the change in patient performance measure through the Timed-up-and-Go (TUG) test in comparison with the pre-operative score. Secondary outcomes will be measured in terms of: a) patient reported outcomes (Hip or Knee Osteoarthritis Outcome Score) and b) range of motion of the relevant joint (hip or knee).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Home-based rehabilitation sessions performed with the digital kinematic 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital kinematic 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 by the therapist and edited according to patient evolution. |
| 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 weeks into the rehabilitation program and at the end of the program (week 8) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Hip Osteoarthritis Outcome Score/Knee Osteoarthritis Outcome Score | The HOOS/KOOS are standardized and validated patient outcome scores that assess functional limitation in patient with hip/knee osteoarthritis | Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando D Correia, MD | Sword Health, SA | Principal Investigator |
| Rosmaninho Seabra, MD | Hospital da Prelada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital da Prelada | Porto | 4250-449 | Portugal |
Yes 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 will be made available here and the excel file with the aggregate results will be made available upon study publication, for at least 5 years.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 13, 2018 | Nov 19, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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|
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| Change in Hip/Knee Range of Motion |
This will be measured (in degrees) automatically by the device |
| Baseline, 4 weeks into the rehabilitation program and at the end of the program (week 8) |
| D012216 |
| Rheumatic Diseases |