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

Total Knee Arthroplasty Clinical Trial

Official title:

Early Implementation of MAKv1 Exoskeleton in TKA Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05544409
• Other study ID #: TKA_MAK
• Status: Completed
• Phase: N/A
• Start date: June 12, 2019
• Est. completion date: February 8, 2021

Study information

• Verified date: September 2022
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Total Knee Arthroplasty

Intervention

Device:
• MAKv1
1 hour sessions with the MAKv1 exoskeleton, thrice per week during 1 month

Locations

Country	Name	City	State
Spain	Hozpital Universitario La Zarzuela	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
MarsiBionics

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Auto-perceived Pain	Presence of pain collected with VAS scale (0 to 10)	Through completion of the use of the device, during 1 month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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