ALS - Amyotrophic Lateral SclerosisNCT07491562
Evaluation of a Structurally Suitable Neck Exoskeleton in Patients With Amyotrophic Lateral Sclerosis
A study testing powered neck exoskeleton in people with ALS - Amyotrophic Lateral Sclerosis, run by University of Utah at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ALS - Amyotrophic Lateral Sclerosis
- What is being tested?
- powered neck exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2024to 18 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ALS diagnosis and neck weakness
Who cannot join
- Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Being tested
- powered neck exoskeleton
- Keywords
- head drop, ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powered neck exoskeletonDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| powered neck exoskeleton | Experimental | Not described Receives: Device: powered neck exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
range of motion
head range of motion (relative to torso) in three anatomical planes
Measured: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start6 Sep 2024
- Primary completion18 Aug 2026
- Study completion18 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS - Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Haohan Zhang, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491562
- Sponsor's protocol ID
- R03_Zhang_ALS_Neck_Brace
- Other IDs
- 1R03HD111884-01A1
- Status last verified
- Oct 2026
- First submitted
- 5 Mar 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Trial to Evaluate Structural Suitability of a Robotic Neck Exoskeleton to Restore Head Movements in Patients With Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT07491562
- Acronym / sponsor ID
- R03_Zhang_ALS_Neck_Brace
- Conditions
- ALS - Amyotrophic Lateral Sclerosis
- Keywords
- head drop, ALS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Sep 2024 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- 18 Aug 2026 (actual)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| powered neck exoskeleton | Experimental | Device: powered neck exoskeleton |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ALS diagnosis and neck weakness
Key exclusion criteria (1 listed)
- Any cognitive deficits or visual impairments that would prevent from safely using the device and completing the tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| powered neck exoskeletonSubjects 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. | Device | powered neck exoskeleton |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing powered neck exoskeleton in people with ALS - Amyotrophic Lateral Sclerosis, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
range of motion (time frame: during the intervention (using the exoskeleton to complete tasks) approximately 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.