StrokeNCT04837144
Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
A study testing Physical Rehabilitation with MAK exoskeleton in people with Stroke and Gait, Hemiplegic, run by MarsiBionics at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Gait, Hemiplegic
- What is being tested?
- Physical Rehabilitation with MAK exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSpain
- Study dates
- 6 Oct 2020to 23 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Stroke, Gait, Hemiplegic
- Being tested
- Physical Rehabilitation with MAK exoskeleton
- Keywords
- exoskeleton, robotic device, gait assistance
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Rehabilitation with MAK exoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes. Receives: Device: Physical Rehabilitation with MAK exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as number of serious device adverse events
Presence of a serious device adverse events where the participant or therapist is involved
Measured: after each use of exoskeleton, for 5 weeks
Secondary outcomes (23)
Safety as presence of adverse events or adverse device events
Presence of a device adverse events where the participant or therapist is involved
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after the use of the device, during 5 weeks
Heart rate [measured with sphygmomanometer]
Number of heart beats per minute
Measured: 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
Measured: 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
Measured: At the first day, 3rd week and 5th week
ROM [measured with goniometer]
Range of Movement
Measured: At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]
Functional Mobility with and without the device
Measured: At the first day, 3rd week and 5th week
System Usability [System Usability Scale]
Measurement of System's Usability measured by the therapist
Measured: At the 5th week
User perception of the device [QUEST 2.0]
QUEST 2.0 will be assessed by the therapist and participant
Measured: At the 5th week
Distance covered walking [6MWT]
6MWT recorded using the device
Measured: At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]
Any device malfunction will be recorded
Measured: During the use of the device, for 5 weeks
Particpant's stability [TUG]
Timed Up and Go Scale
Measured: At the first day, 3rd week and 5th week
Breath Rate [Breathings per minute]
Number of breaths per 1 minute
Measured: Before and after the use of the device, during 5 weeks
SP/DP [sphygmomanometer]
Systolic and Diastolic Pressure measured in mmHg
Measured: Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
SpO2 measured in %
Measured: Before and after the use of the device, during 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start6 Oct 2020
- Primary completion30 Apr 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MarsiBionics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04837144
- Sponsor's protocol ID
- MAKStrokeUSII
- Status last verified
- Jun 2021
- First submitted
- 3 Nov 2020
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Usability of the MAK Exoskeleton in Patients With Stroke
- ClinicalTrials.gov ID
- NCT04837144
- Acronym / sponsor ID
- MAKStrokeUSII
- Conditions
- Stroke, Gait, Hemiplegic
- Keywords
- exoskeleton, robotic device, gait assistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MarsiBionicsIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Physical Rehabilitation with MAK exoskeletonThe Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Rehabilitation with MAK exoskeletonThe 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. | Device | Intervention Group |
Primary outcome
Safety as number of serious device adverse events
Time frame: after each use of exoskeleton, for 5 weeks
Presence of a serious device adverse events where the participant or therapist is involved
23 secondary outcomes
Safety as presence of adverse events or adverse device events
Time frame: after each use of exoskeleton, for 5 weeks
Exercises [measured as time per exercise in seconds]
Time frame: after each use of exoskeleton, for 5 weeks
Transfers [measured as time to carry out the transfers in seconds]
Time frame: 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]
Time frame: at the end of the 5th week
Accessibility [number of potential participants in relation with the included participants]
Time frame: at the end of the 5th week
Fall Prevalence [number of falls during the using of the device]
Time frame: During the use of the device, for 5 weeks
Skin integrity [number of skin injuries related to the device]
Time frame: before and after each use of exoskeleton, for 5 weeks
Pain [VAS scale]
Time frame: Before and after the use of the device, during 5 weeks
Fatigue [Borg Scale]
Time frame: Before and after the use of the device, during 5 weeks
Spasticity [Modified Ashworth Scale]
Time frame: Before and after the use of the device, during 5 weeks
Heart rate [measured with sphygmomanometer]
Time frame: Before and after the use of the device, during 5 weeks
Physical evaluation [number of physical injuries detected]
Time frame: Before and after the use of the device, during 5 weeks
Muscle Strength [measured with Hand Held Dynamometer in N]
Time frame: At the first day, 3rd week and 5th week
ROM [measured with goniometer]
Time frame: At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]
Time frame: At the first day, 3rd week and 5th week
System Usability [System Usability Scale]
Time frame: At the 5th week
User perception of the device [QUEST 2.0]
Time frame: At the 5th week
Distance covered walking [6MWT]
Time frame: At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]
Time frame: During the use of the device, for 5 weeks
Particpant's stability [TUG]
Time frame: At the first day, 3rd week and 5th week
Breath Rate [Breathings per minute]
Time frame: Before and after the use of the device, during 5 weeks
SP/DP [sphygmomanometer]
Time frame: Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
Time frame: Before and after the use of the device, during 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Rehabilitation with MAK exoskeleton in people with Stroke and Gait, Hemiplegic, run by MarsiBionics at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as number of serious device adverse events (time frame: after each use of exoskeleton, for 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2021.