Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke

Marsi Bionics

Status

Completed

Conditions

Stroke

Gait, Hemiplegic

Treatments

Device: Physical Rehabilitation with MAK exoskeleton

Study type

Interventional

Funder types

Industry

Identifiers

NCT04837144

MAKStrokeUSII

Details and patient eligibility

About

This study aims to evaluate the safety and usability of a motorized mobility assistance exoskeleton (MAK). The procedure explores the use of the MAK exoskeleton during the static and dynamic rehabilitation sessions with the intention to evaluate the safety and usability of the device in the studied population. The protocol has been focused on defining how the device can be used appropriately in this population in a safe manner by rehabilitation specialists.The study also aims to assess the safety of clinicians implementing the intervention, as well as possible benefits derived from the use of the device. As a secondary outcome, efficacy measurements will be collected.

Enrollment

6 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 85 years
Weight < 100 kg
Height between 1.5 and 1.9 meters
Anthropometric measurements to fit in the exoskeleton:
Distance from the center of the knee joint to the ground: 42 - 55 cm
Distance from the center of the knee to the groin fold: more than 28 cm.
Perimeter in thigh (midpoint trochanter - epicondyle): 40 - 63 cm.
Perimeter in calf (point of greater volume): 30 - 44 cm.
Ability to follow simple commands and communicate basic needs
Presence of unilateral hemiparesis
Diagnosis of stroke confirmed with imaging tests.
Sub-acute or chronic patients (time since diagnosis 1 month or more)
Score on FAC scale from 1 to 4
Sufficient postural control to maintain standing posture and to take a step with the weight on the affected lower limb, manual assistance or technical aids being allowed

Exclusion criteria

Spasticity > 3 in lower limbs according to the MAS scale
Skin alterations in the contact areas with the exoskeleton
Planned surgical intervention during the duration of the study
Two or more osteoporotic fractures in the lower limbs in the last 2 years
Presence of other pathologies that cause exercise intolerance (such as uncontrolled hypertension, coronary artery disease, arrhythmia, congestive heart failure, Parkinson's, severe lung disease)
Surgical operation in the 3 months prior to the start of the study on the lower limbs