Evaluation of a Structurally Suitable Neck Exoskeleton in Patients With Amyotrophic Lateral Sclerosis
A Feasibility Trial to Evaluate Structural Suitability of a Robotic Neck Exoskeleton to Restore Head Movements in Patients With Amyotrophic Lateral Sclerosis
2 other identifiers
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 6, 2024
CompletedFirst Submitted
Initial submission to the registry
March 5, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2026
March 24, 2026
March 1, 2026
1.9 years
March 5, 2026
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
range of motion
head range of motion (relative to torso) in three anatomical planes
during the intervention (using the exoskeleton to complete tasks) approximately 1 hour
Study Arms (1)
powered neck exoskeleton
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- ALS diagnosis and neck weakness
You may not qualify if:
- Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Utah
Salt Lake City, Utah, 84112, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Mechanical Engineering
Study Record Dates
First Submitted
March 5, 2026
First Posted
March 24, 2026
Study Start
September 6, 2024
Primary Completion (Estimated)
July 15, 2026
Study Completion (Estimated)
July 20, 2026
Last Updated
March 24, 2026
Record last verified: 2026-03