MAKv1 Exoskeleton for TKA Patients: a Safety, Usability and Clinical Effects Trial of an Early Intervention

Study Overview
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Brief Summary
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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
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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).

Official Title
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Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: MAKv1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAKv1<br>The MAKv1 group will receive 1 hour of MAKv1 rehabilitation, thrice per week during 1 month | Device: MAKv1<br>* 1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | event that causes death, life-threat, hospitalization, disability, congenital anomaly, or that requires intervention to prevent permanent impairment or damage | Through study completion, an average of 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Auto-perceived Pain | Presence of pain collected with VAS scale (0 to 10) | Through completion of the use of the device, during 1 month | 
| Heart Rate | Differences in heart rate beofre and after the use of the device (measured in beats/min) | Through completion of the use of the device, during 1 month | 
| Blood pressure | Differences in blood pressure before and after the use of the device (measured in mmHg) | Through completion of the use of the device, during 1 month | 
| Oxygen Saturation | Differences in oxygen satruation before and after the use of the device (measured in %SpO2) | Through completion of the use of the device, during 1 month | 
| Body Termperature | Differences in body temperature before and after the use of the device (measured in celsius) | Through completion of the use of the device, during 1 month | 
| Repetitions per exercise | The number of repetitions per exercise assissted by the MAKv1 device was recorded (mesaured in number of repetitions) | Through completion of the use of the device, during 1 month | 
| QUEST 2.0 scale | QUEST 2.0 scale is a usability scale which rates the perception of the user about the device. | At the first month of the participation in the trial | 
| Range of Motion at the knee | Range of motion of the knee, measured in degrees (º). | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | 
| Muscle strength at the knee | Muscle strength of knee muscles, measured by the modified Medical Research Council scale (mMRC). | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | 
| Knee circumference | Circumference of the knee, measured with a metric tape placed at the upper border of the patella (measured in cm) | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | 
| Quadriceps circumference | Circumference of the quadriceps, measured with a metric tape placed at 10 cm from the upper border of the patella (measured in cm) | Mesaured at the first week, at the first month and at the second month (follow-up) from participation | 
| 6MWT | 6MWT consists of a test were the subject is asked to walk for 6 minutes and the distance covered is collected (measured in meters) | Mesaured at the first month and at the second month (follow-up) from participation | 
| TUG | 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) | Mesaured at the first month and at the second month (follow-up) from participation | 
| FAC | 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. | Mesaured at the first month and at the second month (follow-up) from participation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exoskeleton, total knee arthroplasty, rehabilitation, MAKv1