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Completed

NCT Number: NCT04837144

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MarsiCare

Madrid, Arganda Del Rey, 28500, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Rehabilitation with MAK exoskeleton

Device

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 outcomes

  1. 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

Secondary outcomes

  1. Safety as presence of adverse events or adverse device events

    Time frame: after each use of exoskeleton, for 5 weeks

    Presence of a device adverse events where the participant or therapist is involved

  2. Exercises [measured as time per exercise in seconds]

    Time frame: after each use of exoskeleton, for 5 weeks

    Measured as time per event at each therapy session

  3. Transfers [measured as time to carry out the transfers in seconds]

    Time frame: At each use of exoskeleton, for 5 weeks

    Measured as time and level of assistance to carry out the transfers

  4. 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

    Measured as abandon ratio

  5. Accessibility [number of potential participants in relation with the included participants]

    Time frame: at the end of the 5th week

    Measured as relation between number of participants and number of potential participants which weren't recruited

  6. Fall Prevalence [number of falls during the using of the device]

    Time frame: During the use of the device, for 5 weeks

    Number of falling events ocurred from the participant or therapist

  7. Skin integrity [number of skin injuries related to the device]

    Time frame: before and after each use of exoskeleton, for 5 weeks

    skin integrity measured as the number of skin injuries

  8. Pain [VAS scale]

    Time frame: Before and after the use of the device, during 5 weeks

    Pain registered before and after the use of the device, by the participant and therapist

  9. Fatigue [Borg Scale]

    Time frame: Before and after the use of the device, during 5 weeks

    Fatigue registered before and after the use of the device, by the participant and therapist

  10. Spasticity [Modified Ashworth Scale]

    Time frame: Before and after the use of the device, during 5 weeks

    Spasticity registered before and after the use of the device

  11. Heart rate [measured with sphygmomanometer]

    Time frame: Before and after the use of the device, during 5 weeks

    Number of heart beats per minute

  12. Physical evaluation [number of physical injuries detected]

    Time frame: Before and after the use of the device, during 5 weeks

    Physical Evaluation as presence of tissue damage

  13. Muscle Strength [measured with Hand Held Dynamometer in N]

    Time frame: At the first day, 3rd week and 5th week

    Muscle Strength measured at hip, knee and ankle muscles

  14. ROM [measured with goniometer]

    Time frame: At the first day, 3rd week and 5th week

    Range of Movement

  15. Functional Mobility [Functional Ambulation Category scale]

    Time frame: At the first day, 3rd week and 5th week

    Functional Mobility with and without the device

  16. System Usability [System Usability Scale]

    Time frame: At the 5th week

    Measurement of System's Usability measured by the therapist

  17. User perception of the device [QUEST 2.0]

    Time frame: At the 5th week

    QUEST 2.0 will be assessed by the therapist and participant

  18. Distance covered walking [6MWT]

    Time frame: At the first day, 3rd week and 5th week

    6MWT recorded using the device

  19. Device malfunction [as number and type of device malfunction]

    Time frame: During the use of the device, for 5 weeks

    Any device malfunction will be recorded

  20. Particpant's stability [TUG]

    Time frame: At the first day, 3rd week and 5th week

    Timed Up and Go Scale

  21. Breath Rate [Breathings per minute]

    Time frame: Before and after the use of the device, during 5 weeks

    Number of breaths per 1 minute

  22. SP/DP [sphygmomanometer]

    Time frame: Before and after the use of the device, during 5 weeks

    Systolic and Diastolic Pressure measured in mmHg

  23. SpO2 [pulse oximeter]

    Time frame: Before and after the use of the device, during 5 weeks

    SpO2 measured in %

Sponsors and collaborators

Lead sponsor

MarsiBionics

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Jun 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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