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

NCT04837144 | Completed

• 1 other identifier: MAKStrokeUSII
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

exoskeleton; robotic device; gait assistance

Outcome Measures

Primary Outcomes (1)

• Safety as number of serious device adverse events

  Presence of a serious device adverse events where the participant or therapist is involved

  after each use of exoskeleton, for 5 weeks

Secondary Outcomes (23)

• Safety as presence of adverse events or adverse device events

  after each use of exoskeleton, for 5 weeks

• Exercises [measured as time per exercise in seconds]

  after each use of exoskeleton, for 5 weeks

• Transfers [measured as time to carry out the transfers in seconds]

  At each use of exoskeleton, for 5 weeks

• Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]

  at the end of the 5th week

• Accessibility [number of potential participants in relation with the included participants]

  at the end of the 5th week

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Device: Physical Rehabilitation with MAK exoskeleton

Interventions

Physical Rehabilitation with MAK exoskeleton 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MarsiBionics: lead

Study Sites (1)

MarsiCare

Madrid, Arganda Del Rey, 28500, Spain

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: April 8, 2021
• Study Start: October 6, 2020
• Primary Completion: April 30, 2021
• Study Completion: June 23, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)