Gait, Hemiplegic, Stroke
Conditions
Keywords
exoskeleton, robotic device, gait assistance
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.
Interventions
DEVICEPhysical 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.
Sponsors
MarsiBionics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety as number of serious device adverse events | after each use of exoskeleton, for 5 weeks | Presence of a serious device adverse events where the participant or therapist is involved |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercises [measured as time per exercise in seconds] | after each use of exoskeleton, for 5 weeks | Measured as time per event at each therapy session |
| Transfers [measured as time to carry out the transfers in seconds] | At each use of exoskeleton, for 5 weeks | 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] | at the end of the 5th week | Measured as abandon ratio |
| Accessibility [number of potential participants in relation with the included participants] | at the end of the 5th week | 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] | During the use of the device, for 5 weeks | Number of falling events ocurred from the participant or therapist |
| Skin integrity [number of skin injuries related to the device] | before and after each use of exoskeleton, for 5 weeks | skin integrity measured as the number of skin injuries |
| Pain [VAS scale] | 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 |
| Fatigue [Borg Scale] | 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 |
| Spasticity [Modified Ashworth Scale] | Before and after the use of the device, during 5 weeks | Spasticity registered before and after the use of the device |
| Heart rate [measured with sphygmomanometer] | Before and after the use of the device, during 5 weeks | Number of heart beats per minute |
| Physical evaluation [number of physical injuries detected] | Before and after the use of the device, during 5 weeks | Physical Evaluation as presence of tissue damage |
| Safety as presence of adverse events or adverse device events | after each use of exoskeleton, for 5 weeks | Presence of a device adverse events where the participant or therapist is involved |
| ROM [measured with goniometer] | At the first day, 3rd week and 5th week | Range of Movement |
| Functional Mobility [Functional Ambulation Category scale] | At the first day, 3rd week and 5th week | Functional Mobility with and without the device |
| System Usability [System Usability Scale] | At the 5th week | Measurement of System's Usability measured by the therapist |
| User perception of the device [QUEST 2.0] | At the 5th week | QUEST 2.0 will be assessed by the therapist and participant |
| Distance covered walking [6MWT] | At the first day, 3rd week and 5th week | 6MWT recorded using the device |
| Device malfunction [as number and type of device malfunction] | During the use of the device, for 5 weeks | Any device malfunction will be recorded |
| Particpant's stability [TUG] | At the first day, 3rd week and 5th week | Timed Up and Go Scale |
| Breath Rate [Breathings per minute] | Before and after the use of the device, during 5 weeks | Number of breaths per 1 minute |
| SP/DP [sphygmomanometer] | Before and after the use of the device, during 5 weeks | Systolic and Diastolic Pressure measured in mmHg |
| SpO2 [pulse oximeter] | Before and after the use of the device, during 5 weeks | SpO2 measured in % |
| Muscle Strength [measured with Hand Held Dynamometer in N] | At the first day, 3rd week and 5th week | Muscle Strength measured at hip, knee and ankle muscles |
Countries
Spain
Outcome results
None listed