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

March 19, 2026 updated by: Haohan Zhang, University of Utah

A Feasibility Trial to Evaluate Structural Suitability of a Robotic Neck Exoskeleton to Restore Head Movements in Patients With Amyotrophic Lateral Sclerosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: powered neck exoskeleton
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion
Time Frame: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour
head range of motion (relative to torso) in three anatomical planes
during the intervention (using the exoskeleton to complete tasks) approximately 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2024

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 20, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R03_Zhang_ALS_Neck_Brace
  • 1R03HD111884-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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