NCT07491562

Evaluation of a Structurally Suitable Neck Exoskeleton in Patients With Amyotrophic Lateral Sclerosis

StatusCompleted

PhaseNot applicable

SponsorUniversity of Utah

Primary completionAug 18, 2026

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

Minor Oct 30, 2026 Trial completed Show 4 more changesShow less
- Primary completion date changed from estimate of Jul 15, 2026 to Aug 18, 2026
- Site details revised
- Collaborators expanded, about 12 words
- Eligibility criteria expanded, about 2 words
Mar 19, 2026 Study First Submitted

Minor: routine updates

Endpoints

Primary

range of motion

Timeframe: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour

Arms and interventions

powered neck exoskeletonExperimental

Devices: powered neck exoskeleton

Sites

1 site in 1 country

University of UtahSalt Lake City, Utah, United States

About this trial

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 details

Enrollment: 10 participants (actual)
Started: Sep 6, 2024
Study completion: Aug 18, 2026
Eligibility: all ages, all sexes, no healthy volunteers
Design: Interventional, open label, other
Oversight: No data monitoring committee, FDA-regulated device
Conditions: Amyotrophic Lateral Sclerosis, ALS - Amyotrophic Lateral Sclerosis
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Official title: A Feasibility Trial to Evaluate Structural Suitability of a Robotic Neck Exoskeleton to Restore Head Movements in Patients With Amyotrophic Lateral Sclerosis
First posted: Mar 24, 2026
Registry updated: Nov 3, 2026
Last verified: Oct 2026

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