Status:
COMPLETED
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
Lead Sponsor:
MarsiBionics
Conditions:
Stroke
Gait, Hemiplegic
Eligibility:
All Genders
18-85 years
Phase:
NA
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 rehabilit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2021
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04837144
Start Date
October 6 2020
End Date
June 23 2021
Last Update
June 24 2021
Active Locations (1)
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1
MarsiCare
Madrid, Arganda Del Rey, Spain, 28500