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

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: Completed
• Conditions: Stroke; Gait, Hemiplegic
• Intervention / Treatment: Device: Physical Rehabilitation with MAK exoskeleton

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as presence of adverse events or adverse device events	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]	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]	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]	Measured as abandon ratio	at the end of the 5th week
Accessibility [number of potential participants in relation with the included participants]	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]	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]	skin integrity measured as the number of skin injuries	before and after each use of exoskeleton, for 5 weeks
Pain [VAS scale]	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]	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]	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]	Number of heart beats per minute	Before and after the use of the device, during 5 weeks
Physical evaluation [number of physical injuries detected]	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]	Muscle Strength measured at hip, knee and ankle muscles	At the first day, 3rd week and 5th week
ROM [measured with goniometer]	Range of Movement	At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]	Functional Mobility with and without the device	At the first day, 3rd week and 5th week
System Usability [System Usability Scale]	Measurement of System's Usability measured by the therapist	At the 5th week
User perception of the device [QUEST 2.0]	QUEST 2.0 will be assessed by the therapist and participant	At the 5th week
Distance covered walking [6MWT]	6MWT recorded using the device	At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]	Any device malfunction will be recorded	During the use of the device, for 5 weeks
Particpant's stability [TUG]	Timed Up and Go Scale	At the first day, 3rd week and 5th week
Breath Rate [Breathings per minute]	Number of breaths per 1 minute	Before and after the use of the device, during 5 weeks
SP/DP [sphygmomanometer]	Systolic and Diastolic Pressure measured in mmHg	Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]	SpO2 measured in %	Before and after the use of the device, during 5 weeks

Collaborators and Investigators

• Sponsor: MarsiBionics

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2020
• Primary Completion (ACTUAL): April 30, 2021
• Study Completion (ACTUAL): June 23, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (ACTUAL): April 8, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2021
• Last Update Submitted That Met QC Criteria: June 23, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: robotic device; exoskeleton; gait assistance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Gait Disorders, Neurologic
• Other Study ID 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