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

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Gait, Hemiplegic

Intervention / Treatment
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* Device: Physical Rehabilitation with MAK exoskeleton


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic device, exoskeleton, gait assistance