Evaluation of a Structurally Suitable Neck Exoskeleton in Patients With Amyotrophic Lateral Sclerosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: powered neck exoskeleton.
- Who it may be relevant to
- Registry conditions: ALS - Amyotrophic Lateral Sclerosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Trial to Evaluate Structural Suitability of a Robotic Neck Exoskeleton to Restore Head Movements in Patients With Amyotrophic Lateral Sclerosis
Overview
The investigators will evaluate a new powered neck exoskeleton in patients with amyotrophic lateral sclerosis (ALS) to understand whether this device allows adequate head range of motion and achieves satisfaction from users. In this small cross-sectional 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 using the neck exoskeleton. Tasks include computerized tracking tasks and simulated activities of daily living. Breaks will be added between tasks to avoid fatigue. Head-neck kinematics will be recorded, and range of motion will be computed. Participants will also report their satisfaction of the device.
Interventions
- Device powered neck exoskeleton
Subjects will use the powered neck exoskeleton to control their head-neck motion to complete tasks involving head-neck motions. The neck exoskeleton will be worn and controlled by the users to assist them during tasks.
Primary outcome measures
- range of motion [Time frame: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour]
Eligibility criteria
Inclusion criteria
- ALS diagnosis and neck weakness
Exclusion criteria
- Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Utah — Salt Lake City
Identifiers
NCT: NCT07491562 · R03_Zhang_ALS_Neck_Brace · 1R03HD111884-01A1