Clinical trial NCT04837144: Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
Official title: Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Gait, Hemiplegic
Keywords: exoskeleton
robotic device
gait assistance
Lead sponsor: MarsiBionics
Sponsor class: INDUSTRY
First posted: 2021-04-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety as number of serious device adverse events
timeFrame: after each use of exoskeleton, for 5 weeks
Secondary outcomes:
measure: Safety as presence of adverse events or adverse device events
timeFrame: after each use of exoskeleton, for 5 weeks
measure: Exercises [measured as time per exercise in seconds]
timeFrame: after each use of exoskeleton, for 5 weeks
measure: Transfers [measured as time to carry out the transfers in seconds]
timeFrame: At each use of exoskeleton, for 5 weeks
measure: Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
timeFrame: at the end of the 5th week
measure: Accessibility [number of potential participants in relation with the included participants]
timeFrame: at the end of the 5th week
measure: Fall Prevalence [number of falls during the using of the device]
timeFrame: During the use of the device, for 5 weeks
measure: Skin integrity [number of skin injuries related to the device]
timeFrame: before and after each use of exoskeleton, for 5 weeks
measure: Pain [VAS scale]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Fatigue [Borg Scale]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Spasticity [Modified Ashworth Scale]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Heart rate [measured with sphygmomanometer]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Physical evaluation [number of physical injuries detected]
timeFrame: Before and after the use of the device, during 5 weeks
measure: Muscle Strength [measured with Hand Held Dynamometer in N]
timeFrame: At the first day, 3rd week and 5th week
measure: ROM [measured with goniometer]
timeFrame: At the first day, 3rd week and 5th week
measure: Functional Mobility [Functional Ambulation Category scale]
timeFrame: At the first day, 3rd week and 5th week
measure: System Usability [System Usability Scale]
timeFrame: At the 5th week
measure: User perception of the device [QUEST 2.0]
timeFrame: At the 5th week
measure: Distance covered walking [6MWT]
timeFrame: At the first day, 3rd week and 5th week
measure: Device malfunction [as number and type of device malfunction]
timeFrame: During the use of the device, for 5 weeks
measure: Particpant's stability [TUG]
timeFrame: At the first day, 3rd week and 5th week
measure: Breath Rate [Breathings per minute]
timeFrame: Before and after the use of the device, during 5 weeks
measure: SP/DP [sphygmomanometer]
timeFrame: Before and after the use of the device, during 5 weeks
measure: SpO2 [pulse oximeter]
timeFrame: Before and after the use of the device, during 5 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: MarsiCare
state: Arganda Del Rey
Study officials:
References: