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

Not Applicable

Completed

• Conditions: Total Knee Arthroplasty
• Interventions: Device: MAKv1

• Registration Number: NCT05544409
• Lead Sponsor: MarsiBionics

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).

Study Timeline

• Study Start: 2019-06-12
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-08
• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-15
• Last Update Submitted: 2022-09-15
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MAKv1	MAKv1	The MAKv1 group will receive 1 hour of MAKv1 rehabilitation, thrice per week during 1 month

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Auto-perceived Pain	Through completion of the use of the device, during 1 month	Presence of pain collected with VAS scale (0 to 10)
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)
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)
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.
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)
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).
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)
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.
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)

Trial Locations

Locations (1)

Hozpital Universitario La Zarzuela; 🇪🇸 Madrid, Spain