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

NCT ID: NCT04837144

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2021-06-23

Brief Summary

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.

Conditions

Stroke; Gait, Hemiplegic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group

The Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes.

Group Type: EXPERIMENTAL

Physical Rehabilitation with MAK exoskeleton

Intervention Type: DEVICE

The participants will assist to 9 physical rehabilitation sessions with the MAK exoskeleton. During these sessions, different movements and therapies will be conducted using the studied device.

Interventions

Physical Rehabilitation with MAK exoskeleton

The participants will assist to 9 physical rehabilitation sessions with the MAK exoskeleton. During these sessions, different movements and therapies will be conducted using the studied device.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MarsiBionics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

MarsiCare

Madrid, Arganda Del Rey, Spain

Countries

Spain

Other Identifiers

MAKStrokeUSII

Identifier Type: -

Identifier Source: org_study_id