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

MarsiBionics6 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke Gait, Hemiplegic

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Safety as number of serious device adverse events

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

Time frame: after each use of exoskeleton, for 5 weeks

Secondary Outcomes

Safety as presence of adverse events or adverse device events

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Before and after the use of the device, during 5 weeks

Heart rate [measured with sphygmomanometer]

Number of heart beats per minute

Time frame: 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

Time frame: 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

Time frame: At the first day, 3rd week and 5th week

ROM [measured with goniometer]

Range of Movement

Time frame: At the first day, 3rd week and 5th week

Functional Mobility [Functional Ambulation Category scale]

Functional Mobility with and without the device

Time frame: At the first day, 3rd week and 5th week

System Usability [System Usability Scale]

Measurement of System's Usability measured by the therapist

Time frame: At the 5th week

User perception of the device [QUEST 2.0]

QUEST 2.0 will be assessed by the therapist and participant

Time frame: At the 5th week

Distance covered walking [6MWT]

6MWT recorded using the device

Time frame: At the first day, 3rd week and 5th week

Device malfunction [as number and type of device malfunction]

Any device malfunction will be recorded

Time frame: During the use of the device, for 5 weeks

Particpant's stability [TUG]

Timed Up and Go Scale

Time frame: At the first day, 3rd week and 5th week

Breath Rate [Breathings per minute]

Number of breaths per 1 minute

Time frame: Before and after the use of the device, during 5 weeks

SP/DP [sphygmomanometer]

Systolic and Diastolic Pressure measured in mmHg

Time frame: Before and after the use of the device, during 5 weeks

SpO2 [pulse oximeter]

SpO2 measured in %

Time frame: Before and after the use of the device, during 5 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes