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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04837144
• Other study ID #: MAKStrokeUSII
• Status: Completed
• Phase: N/A
• Start date: October 6, 2020
• Est. completion date: June 23, 2021

Study information

• Verified date: June 2021
• Source: MarsiBionics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 23, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Spain	MarsiCare	Madrid	Arganda Del Rey

Sponsors (1)

Lead Sponsor	Collaborator
MarsiBionics

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Heart rate [measured with sphygmomanometer]	Number of heart beats per minute	Before and after the use of the device, during 5 weeks
Secondary	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
Secondary	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
Secondary	ROM [measured with goniometer]	Range of Movement	At the first day, 3rd week and 5th week
Secondary	Functional Mobility [Functional Ambulation Category scale]	Functional Mobility with and without the device	At the first day, 3rd week and 5th week
Secondary	System Usability [System Usability Scale]	Measurement of System's Usability measured by the therapist	At the 5th week
Secondary	User perception of the device [QUEST 2.0]	QUEST 2.0 will be assessed by the therapist and participant	At the 5th week
Secondary	Distance covered walking [6MWT]	6MWT recorded using the device	At the first day, 3rd week and 5th week
Secondary	Device malfunction [as number and type of device malfunction]	Any device malfunction will be recorded	During the use of the device, for 5 weeks
Secondary	Particpant's stability [TUG]	Timed Up and Go Scale	At the first day, 3rd week and 5th week
Secondary	Breath Rate [Breathings per minute]	Number of breaths per 1 minute	Before and after the use of the device, during 5 weeks
Secondary	SP/DP [sphygmomanometer]	Systolic and Diastolic Pressure measured in mmHg	Before and after the use of the device, during 5 weeks
Secondary	SpO2 [pulse oximeter]	SpO2 measured in %	Before and after the use of the device, during 5 weeks