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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04837144
Other study ID # MAKStrokeUSII
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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