Back to resultsEvaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
Primary Purpose
Stroke, Gait, Hemiplegic
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical Rehabilitation with MAK exoskeleton
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring exoskeleton, robotic device, gait assistance
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
Sites / Locations
- MarsiCare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention Group
Arm Description
The Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes.
Outcomes
Primary Outcome Measures
Safety as number of serious device adverse events
Presence of a serious device adverse events where the participant or therapist is involved
Secondary Outcome Measures
Safety as presence of adverse events or adverse device events
Presence of a device adverse events where the participant or therapist is involved
Exercises [measured as time per exercise in seconds]
Measured as time per event at each therapy session
Transfers [measured as time to carry out the transfers in seconds]
Measured as time and level of assistance to carry out the transfers
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
Measured as abandon ratio
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
Fall Prevalence [number of falls during the using of the device]
Number of falling events ocurred from the participant or therapist
Skin integrity [number of skin injuries related to the device]
skin integrity measured as the number of skin injuries
Pain [VAS scale]
Pain registered before and after the use of the device, by the participant and therapist
Fatigue [Borg Scale]
Fatigue registered before and after the use of the device, by the participant and therapist
Spasticity [Modified Ashworth Scale]
Spasticity registered before and after the use of the device
Heart rate [measured with sphygmomanometer]
Number of heart beats per minute
Physical evaluation [number of physical injuries detected]
Physical Evaluation as presence of tissue damage
Muscle Strength [measured with Hand Held Dynamometer in N]
Muscle Strength measured at hip, knee and ankle muscles
ROM [measured with goniometer]
Range of Movement
Functional Mobility [Functional Ambulation Category scale]
Functional Mobility with and without the device
System Usability [System Usability Scale]
Measurement of System's Usability measured by the therapist
User perception of the device [QUEST 2.0]
QUEST 2.0 will be assessed by the therapist and participant
Distance covered walking [6MWT]
6MWT recorded using the device
Device malfunction [as number and type of device malfunction]
Any device malfunction will be recorded
Particpant's stability [TUG]
Timed Up and Go Scale
Breath Rate [Breathings per minute]
Number of breaths per 1 minute
SP/DP [sphygmomanometer]
Systolic and Diastolic Pressure measured in mmHg
SpO2 [pulse oximeter]
SpO2 measured in %
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04837144
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 6, 2020 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
June 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MarsiBionics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait, Hemiplegic
Keywords
exoskeleton, robotic device, gait assistance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes.
Intervention Type
Device
Intervention Name(s)
Physical Rehabilitation with MAK exoskeleton
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety as number of serious device adverse events
Description
Presence of a serious device adverse events where the participant or therapist is involved
Time Frame
after each use of exoskeleton, for 5 weeks
Secondary Outcome Measure Information:
Title
Safety as presence of adverse events or adverse device events
Description
Presence of a device adverse events where the participant or therapist is involved
Time Frame
after each use of exoskeleton, for 5 weeks
Title
Exercises [measured as time per exercise in seconds]
Description
Measured as time per event at each therapy session
Time Frame
after each use of exoskeleton, for 5 weeks
Title
Transfers [measured as time to carry out the transfers in seconds]
Description
Measured as time and level of assistance to carry out the transfers
Time Frame
At each use of exoskeleton, for 5 weeks
Title
Acceptability [number of participants which discontinue the participation during the trial in relation with the included participants]
Description
Measured as abandon ratio
Time Frame
at the end of the 5th week
Title
Accessibility [number of potential participants in relation with the included participants]
Description
Measured as relation between number of participants and number of potential participants which weren't recruited
Time Frame
at the end of the 5th week
Title
Fall Prevalence [number of falls during the using of the device]
Description
Number of falling events ocurred from the participant or therapist
Time Frame
During the use of the device, for 5 weeks
Title
Skin integrity [number of skin injuries related to the device]
Description
skin integrity measured as the number of skin injuries
Time Frame
before and after each use of exoskeleton, for 5 weeks
Title
Pain [VAS scale]
Description
Pain registered before and after the use of the device, by the participant and therapist
Time Frame
Before and after the use of the device, during 5 weeks
Title
Fatigue [Borg Scale]
Description
Fatigue registered before and after the use of the device, by the participant and therapist
Time Frame
Before and after the use of the device, during 5 weeks
Title
Spasticity [Modified Ashworth Scale]
Description
Spasticity registered before and after the use of the device
Time Frame
Before and after the use of the device, during 5 weeks
Title
Heart rate [measured with sphygmomanometer]
Description
Number of heart beats per minute
Time Frame
Before and after the use of the device, during 5 weeks
Title
Physical evaluation [number of physical injuries detected]
Description
Physical Evaluation as presence of tissue damage
Time Frame
Before and after the use of the device, during 5 weeks
Title
Muscle Strength [measured with Hand Held Dynamometer in N]
Description
Muscle Strength measured at hip, knee and ankle muscles
Time Frame
At the first day, 3rd week and 5th week
Title
ROM [measured with goniometer]
Description
Range of Movement
Time Frame
At the first day, 3rd week and 5th week
Title
Functional Mobility [Functional Ambulation Category scale]
Description
Functional Mobility with and without the device
Time Frame
At the first day, 3rd week and 5th week
Title
System Usability [System Usability Scale]
Description
Measurement of System's Usability measured by the therapist
Time Frame
At the 5th week
Title
User perception of the device [QUEST 2.0]
Description
QUEST 2.0 will be assessed by the therapist and participant
Time Frame
At the 5th week
Title
Distance covered walking [6MWT]
Description
6MWT recorded using the device
Time Frame
At the first day, 3rd week and 5th week
Title
Device malfunction [as number and type of device malfunction]
Description
Any device malfunction will be recorded
Time Frame
During the use of the device, for 5 weeks
Title
Particpant's stability [TUG]
Description
Timed Up and Go Scale
Time Frame
At the first day, 3rd week and 5th week
Title
Breath Rate [Breathings per minute]
Description
Number of breaths per 1 minute
Time Frame
Before and after the use of the device, during 5 weeks
Title
SP/DP [sphygmomanometer]
Description
Systolic and Diastolic Pressure measured in mmHg
Time Frame
Before and after the use of the device, during 5 weeks
Title
SpO2 [pulse oximeter]
Description
SpO2 measured in %
Time Frame
Before and after the use of the device, during 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
MarsiCare
City
Madrid
State/Province
Arganda Del Rey
ZIP/Postal Code
28500
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There's no intention to share the individual participant data with researchers outside the scope of the present study. The participant data will be collected anonymized using a code for each participant. The data will be collected and stored according to the EU regulations and local laws and guidelines.
Learn more about this trial
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
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