Total Knee Arthroplasty
Conditions
Keywords
exoskeleton, total knee arthroplasty, rehabilitation, MAKv1
Brief summary
The present study analyzes the effects of using a portable single limb exoskeleton (MAKv1) in patients with total knee artrhoplasty (TKA). Safety, usability and clinical effects of an early intervention program with the device with an early implementation are studied.
Detailed description
The present study will analyze the safety, usability and clinical effects of using the MAKv1 exoskeleton in TKA patients. The intervention will consist of 1 hour sessions with the MAKv1 device, thrice per week during 1 month. Safety measurements (serious adverse events, vitals, and auto-perceived pain) will be collected at each session with the device, along with the repetitions performed at each exercise assisted with the device. After the first week is completed, measurements regarding clinical effect will be collected. Also, at the end of the month were the participants receive the sessions with the device, clinical effects will be measured again, along with a questionnaire to collect the users' perception of the device (QUEST 2.0).
Interventions
DEVICEMAKv1
1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month
Sponsors
MarsiBionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* patients undergoing TKA surgery
Exclusion criteria
* inability to understand simple instructions * postoperative complications that may be a risk to use the exoskeleton * other conditions that prevented mobilisation in early stages after TKA * weight \> 100 kg * size \< 150 cm * size \> 190 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious Adverse Events | Through study completion, an average of 2 months | event that causes death, life-threat, hospitalization, disability, congenital anomaly, or that requires intervention to prevent permanent impairment or damage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Through completion of the use of the device, during 1 month | Differences in heart rate beofre and after the use of the device (measured in beats/min) |
| Blood pressure | Through completion of the use of the device, during 1 month | Differences in blood pressure before and after the use of the device (measured in mmHg) |
| Oxygen Saturation | Through completion of the use of the device, during 1 month | Differences in oxygen satruation before and after the use of the device (measured in %SpO2) |
| Body Termperature | Through completion of the use of the device, during 1 month | Differences in body temperature before and after the use of the device (measured in celsius) |
| Repetitions per exercise | Through completion of the use of the device, during 1 month | The number of repetitions per exercise assissted by the MAKv1 device was recorded (mesaured in number of repetitions) |
| QUEST 2.0 scale | At the first month of the participation in the trial | QUEST 2.0 scale is a usability scale which rates the perception of the user about the device. |
| Auto-perceived Pain | Through completion of the use of the device, during 1 month | Presence of pain collected with VAS scale (0 to 10) |
| Muscle strength at the knee | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | Muscle strength of knee muscles, measured by the modified Medical Research Council scale (mMRC). |
| Knee circumference | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | Circumference of the knee, measured with a metric tape placed at the upper border of the patella (measured in cm) |
| Quadriceps circumference | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | Circumference of the quadriceps, measured with a metric tape placed at 10 cm from the upper border of the patella (measured in cm) |
| 6MWT | Mesaured at the first month and at the second month (follow-up) from participation | 6MWT consists of a test were the subject is asked to walk for 6 minutes and the distance covered is collected (measured in meters) |
| TUG | Mesaured at the first month and at the second month (follow-up) from participation | The Timed Up and Go test consists of a test were the subject is asked to stand up from a chair, cover 3 meters in a straight line, and then go back to sit in the same chair. Time to complete the task is recorded (measured in seconds) |
| FAC | Mesaured at the first month and at the second month (follow-up) from participation | The functional Ambulation Categories scale measures the patient's ability according to the assistance needed to deambulate. A score is given from 0 to 5. |
| Range of Motion at the knee | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | Range of motion of the knee, measured in degrees (º). |
Countries
Spain
Outcome results
None listed