Using Gaze to Enable Head-neck Movements in Patients With Head Drop
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Utah
About this trial
The investigators will develop and evaluate controllers for a powered neck exoskeleton in patients with amyotrophic lateral sclerosis (ALS) to understand how to allow adequate personalization and function and achieves satisfaction from users. In this small device feasibility study, participants will be enrolled from the ALS clinic at the University of Utah Hospital. After obtaining written consent, participants will perform tasks while using the neck exoskeleton with the controllers. Tasks include computerized tracking tasks and simulated activities of daily living. Breaks will be added between tasks to avoid fatigue. Head-neck kinematics, gaze data, controller preferences, and survey responses will be recorded.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
neck weakness and age over 18
Disqualifiers
Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks and poor device fitting.
Trial design
Design model
Crossover
Treatments tested in this trial
neck exoskeleton controller
DeviceSubjects will use the neck exoskeleton controller to move their head-neck and complete tasks involving head-neck motions. The neck exoskeleton will be worn and controlled by the users to assist them during tasks.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: controller 1Experimental treatment 1 intervention
Group B: controller 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
number of tuning
number of user feedback provided to personalize/tune controller parameters for their preferred exoskeleton performance
Time frame
during the intervention (using the exoskeleton to complete tasks) approximately 1 hourSponsors and contacts
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Source ClinicalTrials.gov