Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The Intervention Group will receive 9 physical rehabilitation sessions using the MAK device. Each session will consist of approximately 90 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Exercises [measured as time per exercise in seconds] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MarsiCare | Madrid | Arganda Del Rey | 28500 | Spain |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Measured as time per event at each therapy session
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Before and after the use of the device, during 5 weeks |
| Heart rate [measured with sphygmomanometer] | Number of heart beats per minute | 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 | 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 | At the first day, 3rd week and 5th week |
| ROM [measured with goniometer] | Range of Movement | At the first day, 3rd week and 5th week |
| Functional Mobility [Functional Ambulation Category scale] | Functional Mobility with and without the device | At the first day, 3rd week and 5th week |
| System Usability [System Usability Scale] | Measurement of System's Usability measured by the therapist | At the 5th week |
| User perception of the device [QUEST 2.0] | QUEST 2.0 will be assessed by the therapist and participant | At the 5th week |
| Distance covered walking [6MWT] | 6MWT recorded using the device | At the first day, 3rd week and 5th week |
| Device malfunction [as number and type of device malfunction] | Any device malfunction will be recorded | During the use of the device, for 5 weeks |
| Particpant's stability [TUG] | Timed Up and Go Scale | At the first day, 3rd week and 5th week |
| Breath Rate [Breathings per minute] | Number of breaths per 1 minute | Before and after the use of the device, during 5 weeks |
| SP/DP [sphygmomanometer] | Systolic and Diastolic Pressure measured in mmHg | Before and after the use of the device, during 5 weeks |
| SpO2 [pulse oximeter] | SpO2 measured in % | Before and after the use of the device, during 5 weeks |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |