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

June 23, 2021 updated by: MarsiBionics
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Arganda Del Rey
      • Madrid, Arganda Del Rey, Spain, 28500
        • MarsiCare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety as number of serious device adverse events
Time Frame: after each use of exoskeleton, for 5 weeks
Presence of a serious device adverse events where the participant or therapist is involved
after each use of exoskeleton, for 5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety as presence of adverse events or adverse device events
Time Frame: after each use of exoskeleton, for 5 weeks
Presence of a device adverse events where the participant or therapist is involved
after each use of exoskeleton, for 5 weeks
Exercises [measured as time per exercise in seconds]
Time Frame: after each use of exoskeleton, for 5 weeks
Measured as time per event at each therapy session
after each use of exoskeleton, for 5 weeks
Transfers [measured as time to carry out the transfers in seconds]
Time Frame: At each use of exoskeleton, for 5 weeks
Measured as time and level of assistance to carry out the transfers
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]
Time Frame: at the end of the 5th week
Measured as abandon ratio
at the end of the 5th week
Accessibility [number of potential participants in relation with the included participants]
Time Frame: at the end of the 5th week
Measured as relation between number of participants and number of potential participants which weren't recruited
at the end of the 5th week
Fall Prevalence [number of falls during the using of the device]
Time Frame: During the use of the device, for 5 weeks
Number of falling events ocurred from the participant or therapist
During the use of the device, for 5 weeks
Skin integrity [number of skin injuries related to the device]
Time Frame: before and after each use of exoskeleton, for 5 weeks
skin integrity measured as the number of skin injuries
before and after each use of exoskeleton, for 5 weeks
Pain [VAS scale]
Time Frame: Before and after the use of the device, during 5 weeks
Pain registered before and after the use of the device, by the participant and therapist
Before and after the use of the device, during 5 weeks
Fatigue [Borg Scale]
Time Frame: Before and after the use of the device, during 5 weeks
Fatigue registered before and after the use of the device, by the participant and therapist
Before and after the use of the device, during 5 weeks
Spasticity [Modified Ashworth Scale]
Time Frame: Before and after the use of the device, during 5 weeks
Spasticity registered before and after the use of the device
Before and after the use of the device, during 5 weeks
Heart rate [measured with sphygmomanometer]
Time Frame: Before and after the use of the device, during 5 weeks
Number of heart beats per minute
Before and after the use of the device, during 5 weeks
Physical evaluation [number of physical injuries detected]
Time Frame: Before and after the use of the device, during 5 weeks
Physical Evaluation as presence of tissue damage
Before and after the use of the device, during 5 weeks
Muscle Strength [measured with Hand Held Dynamometer in N]
Time Frame: At the first day, 3rd week and 5th week
Muscle Strength measured at hip, knee and ankle muscles
At the first day, 3rd week and 5th week
ROM [measured with goniometer]
Time Frame: At the first day, 3rd week and 5th week
Range of Movement
At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]
Time Frame: At the first day, 3rd week and 5th week
Functional Mobility with and without the device
At the first day, 3rd week and 5th week
System Usability [System Usability Scale]
Time Frame: At the 5th week
Measurement of System's Usability measured by the therapist
At the 5th week
User perception of the device [QUEST 2.0]
Time Frame: At the 5th week
QUEST 2.0 will be assessed by the therapist and participant
At the 5th week
Distance covered walking [6MWT]
Time Frame: At the first day, 3rd week and 5th week
6MWT recorded using the device
At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]
Time Frame: During the use of the device, for 5 weeks
Any device malfunction will be recorded
During the use of the device, for 5 weeks
Particpant's stability [TUG]
Time Frame: At the first day, 3rd week and 5th week
Timed Up and Go Scale
At the first day, 3rd week and 5th week
Breath Rate [Breathings per minute]
Time Frame: Before and after the use of the device, during 5 weeks
Number of breaths per 1 minute
Before and after the use of the device, during 5 weeks
SP/DP [sphygmomanometer]
Time Frame: Before and after the use of the device, during 5 weeks
Systolic and Diastolic Pressure measured in mmHg
Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
Time Frame: Before and after the use of the device, during 5 weeks
SpO2 measured in %
Before and after the use of the device, during 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MarsiBionics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MAKStrokeUSII

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There's no intention to share the individual participant data with researchers outside the scope of the present study. The participant data will be collected anonymized using a code for each participant. The data will be collected and stored according to the EU regulations and local laws and guidelines.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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