An interventional study of Exoskeleton rehabilitation in Cerebral Palsy, SMA II and Neuromuscular Diseases, sponsored by MarsiBionics. Completed at 1 site in Spain. Open to participants aged 3 Years to 14 Years. Per ClinicalTrials.gov, last updated 2021-04-08.
Sponsored by MarsiBionics · Not applicable, Interventional, and Device feasibility
This study aims to evaluate the safety, usability and acceptability of a motorized mobility assistance exoskeleton. The protocol explores the use of the motorized device during static and dynamic rehabilitation sessions focused on walking and functional activities, with the expectation of evaluating the safety and usability of the device in the population studied. The protocol has been focused on defining how the device can be used appropriately in this population in a safe and effective manner by rehabilitation specialists. The study also aims to assess the safety of clinical staff who implement the intervention.
1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.
This study's enrollment of 6 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →MarsiBionics is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
9 treatment sessions will be performed with the ATLAS2030 exoskeleton. The rehabilitation sessions last approximately 90 minutes. Two sessions are scheduled per week, for two weeks.
Device: Exoskeleton rehabilitation
The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.
Also known as: ATLAS2030, ATLAS, robot-assisted therapy
Safety as number of serious device adverse events
Presence of a serious device adverse events where the participant or therapist is involved
Time frame: after each use of exoskeleton, for 5 weeks
Safety as presence of adverse events or adverse device events
Presence of a device adverse events where the participant or therapist is involved.
Time frame: after each use of exoskeleton, for 5 weeks
Exercises [measured as time per exercise in seconds]
Measured as time per event for at each therapy session.
Time frame: after each use of exoskeleton, for 5 weeks
Transfers [measured as time to carry out the transfers in seconds]
Measured as time to carry out the transfers
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]
Measured as abandon ratio
Time frame: At the end of the study, at 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
Time frame: At the end of the study, at the 5th week
Fall Prevalence [number of falls during the using of the device]
Number of falling events ocurred from the participant or therapist
Time frame: 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
Time frame: before and after each use of exoskeleton, for 5 weeks
Pain [Wong-Baker FACES Pain Rating Scale]
Pain registered before and after the use of the device, by the participant and therapist. The options are from 1 to 6. A higher score means a worse outcome.
Time frame: Before and after the use of the device, during 5 weeks
Fatigue [Borg Rating Scale of Perceived Exertion]
Fatigue registered before and after the use of the device, by the participant and therapist. Measured from 0 to 10, being 0 as fully rested and 10 very tired. A higher score means a worse outcome.
Time frame: 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
Time frame: Before and after the use of the device, during 5 weeks
Heart rate [sphygmomanometer]
Number of heart bets per minute
Time frame: 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
Time frame: 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
Time frame: At the first day, 3rd week and 5th week
ROM [measured with goniometer]
Range of Movement
Time frame: At the first day, 3rd week and 5th week
Functional Mobility [Functional Ambulation Category scale]
Functional Mobility with and without the device
Time frame: At the first day, 3rd week and 5th week
System Usability [System Usability Scale]
Measurement of System's Usability measured by the therapist
Time frame: At the end of the study, 5th week
User perception of the device [QUEST 2.0 and QUEST 2.1]
QUEST 2.0 will be assessed by the therapist, and QUEST 2.1 will be assessed by the participant
Time frame: At the end of the study, 5th week
Distance covered walking [6MWT]
6MWT recorded using the device
Time frame: At the first day, 3rd week and 5th week
Device malfunction [as number and type of device malfunction]
Any device malfunction will be recorded
Time frame: During the use of the device, for 5 weeks
Particpant's stability [Functional Reach Test]
Functional Reach Test
Time frame: At the first day, 3rd week and 5th week
Systolic/Diastolic Pressure [sphygmomanometer]
Systolic Pressure and Diastolic Pressure measured with sphygmomanometer (measured in mmHg)
Time frame: Before and after the use of the device, during 5 weeks
Breath Rate [number of breaths per minute]
Number of breaths per minute
Time frame: Before and after the use of the device, during 5 weeks
SpO2 [pulse oximeter]
SpO2 measured as %
Time frame: Before and after the use of the device, during 5 weeks
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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