HemiparesisNCT05509101
Improving Myoelectric Prosthetic and Orthotic Limb Control
A study of Hemiparesis, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (> 8) surface electromyographic (sEMG)… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiparesis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- First-ever ischemic or hemorrhagic stroke
- Chronic Stroke (at least 6 months since onset)
- Chronic hemiparesis
- Functional range of motion for contralateral arm
Who cannot join
- Individuals who are currently Incarcerated
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah
Salt Lake City, Utah, 84132-2101
Heidi Hansen, 801.585.2373, heidi.hansen@hsc.utah.edu
About this study
Official title: Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes
The purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (> 8) surface electromyographic (sEMG) electrodes.
Read the detailed description
This study looks to improve control of myoelectrically-controlled advanced powered orthoses (orthoses that use the body's muscle signals to drive movements of a robotic exoskeleton) by using advanced predictive decode algorithms, and the use of high count (> 8) surface electromyographic (sEMG) electrodes.
- Conditions
- Hemiparesis
- Being tested
- commercially available control algorithm, experimental control algorithm
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
commercially available control algorithmOther
Control of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms.
experimental control algorithmOther
Control of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Clinically Available Control Algorithm (MyoPro) | Active comparator | Binary control of the orthosis is based on a clinically available control algorithm. This condition serves as a control. Participants will use a commercially available device, the MyoPro. Receives: Other: commercially available control algorithm |
| High-Density EMG Control Algorithm | Experimental | Control of the orthosis is based on residual muscle activity mapped to intended movement using advanced predicted algorithms. This condition is a novel algorithm and serves as the experimental condition. Receives: Other: experimental control algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Box and Blocks Test (BBT)
The Box and Blocks test is performed using the orthotic device under each condition. The individual puts on the device for a maximum of two hours. During that time wearing the device, they will use two different algorithms for controlling the device to complete the Box and Blocks Test.
Measured: while using the device (up to 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start1 Mar 2017
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob George, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509101
- Sponsor's protocol ID
- IRB_00098851
- Status last verified
- Apr 2026
- First submitted
- 15 Aug 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Myoelectric Prosthetic and Orthotic Limb Control Using Predictive Regression Algorithms and High-count Surface Electrodes
- ClinicalTrials.gov ID
- NCT05509101
- Acronym / sponsor ID
- IRB_00098851
- Conditions
- Hemiparesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Aug 2022 (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 purpose of this study is to improve control of myoelectrically-controlled advanced orthotic devices (an exoskeleton device that use the body's muscle signals to drive movements of a robotic brace) by using advanced predictive decode algorithms, and the use of high count (> 8) surface electromyographic (sEMG) electrodes.
Detailed description
This study looks to improve control of myoelectrically-controlled advanced powered orthoses (orthoses that use the body's muscle signals to drive movements of a robotic exoskeleton) by using advanced predictive decode algorithms, and the use of high count (> 8) surface electromyographic (sEMG) electrodes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinically Available Control Algorithm (MyoPro) | Active comparator | Other: commercially available control algorithmBinary control of the orthosis is based on a clinically available control algorithm. This condition serves as a control. Participants will use a commercially available device, the MyoPro. |
| High-Density EMG Control Algorithm | Experimental | Other: experimental control algorithmControl of the orthosis is based on residual muscle activity mapped to intended movement using advanced predicted algorithms. This condition is a novel algorithm and serves as the experimental condition. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First-ever ischemic or hemorrhagic stroke
- Chronic Stroke (at least 6 months since onset)
- Chronic hemiparesis
- Functional range of motion for contralateral arm
Key exclusion criteria (1 listed)
- Individuals who are currently Incarcerated
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 |
|---|---|---|
| commercially available control algorithmControl of the prosthesis/orthosis is based on clinical standard of care using commercially available control algorithms. | Other | Clinically Available Control Algorithm (MyoPro) |
| experimental control algorithmControl of the orthosis is based on residual muscle activity mapped to intended movement using high density electromyography and artificial intelligence control algorithms. | Other | High-Density EMG Control Algorithm |
Primary outcome
Box and Blocks Test (BBT)
Time frame: while using the device (up to 2 hours)
The Box and Blocks test is performed using the orthotic device under each condition. The individual puts on the device for a maximum of two hours. During that time wearing the device, they will use two different algorithms for controlling the device to complete the Box and Blocks Test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Hemiparesis, 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 4 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: looking for participants now, as of the sponsor's last update on 6 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi Hansen, BS (801.585.2373, heidi.hansen@hsc.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Box and Blocks Test (BBT) (time frame: while using the device (up to 2 hours)). 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 6 May 2026.