StrokeNCT03619772
EMG Training for Altering Activation Patterns After Stroke
A study testing Bilateral and Unilateral in people with Stroke and Weakness, Muscle, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Weakness, Muscle, Coordination Lack
- What is being tested?
- Bilateral and Unilateral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2018to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single, unilateral stroke at least 6 months prior to enrollment
- Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale
Who cannot join
- Visual neglect or deficits (with inability to compensate)
- Upper extremity orthopedic conditions that interfere with movement
- Cerebellar stroke
- Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Altering Activation Patterns With EMG Training in the Distal Upper Extremity After Stroke
Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.
Read the detailed description
Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.
- Conditions
- Stroke, Weakness, Muscle, Coordination Lack
- Being tested
- Bilateral, Unilateral
- Keywords
- hand, stroke, therapy, rehabilitation
- Medical subject headings
- Stroke, Muscle Weakness, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilateralOther
Participants will control game using EMG from both upper limbs.
UnilateralOther
Participants will control game using EMG from the more impaired upper limb.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral | Experimental | Participants will control game using EMG from both upper limbs. Receives: Other: Bilateral |
| Unilateral | Active comparator | Participants will control game using the more impaired upper limb. Receives: Other: Unilateral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Completion Time for Timed Test
Time to complete movement to 16 randomized targets
Measured: Baseline and 3 weeks (immediately post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start28 Jun 2018
- Primary completion31 Oct 2020
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina State University, Marquette University, Medical University of South Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Elliot Roth, Shirley Ryan AbilityLab
- Investigators
- Elliot Roth, MD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619772
- Sponsor's protocol ID
- STU00206747
- Other IDs
- R01HD075813
- Status last verified
- Oct 2023
- First submitted
- 3 Aug 2018
- Last updated
- 20 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22.
PubMed 35320135
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Altering Activation Patterns With EMG Training in the Distal Upper Extremity After Stroke
- ClinicalTrials.gov ID
- NCT03619772
- Acronym / sponsor ID
- STU00206747
- Conditions
- Stroke, Weakness, Muscle, Coordination Lack
- Keywords
- hand, stroke, therapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- North Carolina State University, Marquette University, Medical University of South Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Posted 20 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.
Detailed description
Increased impairment of the hand is commonly reported as an outcome occurring after a stroke. This impairment is due mainly to the decreased ability to modulate appropriate muscle activation patterns. Issues with appropriately modifying activation patterns can profoundly affect tasks of daily living. This study is evaluating a novel software focusing on retraining hand muscle activation patterns through an Electromyographic (EMG) controlled game. Stroke survivors with chronic, severe hemiparesis of the hand will participate in a longitudinal study consisting of 3 weeks of training. We hypothesize that stroke survivors will experience a decrease in time to complete a test of EMG control, as well as improvement in hand motor control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral | Experimental | Other: BilateralParticipants will control game using EMG from both upper limbs. |
| Unilateral | Active comparator | Other: UnilateralParticipants will control game using the more impaired upper limb. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Single, unilateral stroke at least 6 months prior to enrollment
- Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale
Key exclusion criteria (4 listed)
- Visual neglect or deficits (with inability to compensate)
- Upper extremity orthopedic conditions that interfere with movement
- Cerebellar stroke
- Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.
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 |
|---|---|---|
| BilateralParticipants will control game using EMG from both upper limbs. | Other | Bilateral |
| UnilateralParticipants will control game using EMG from the more impaired upper limb. | Other | Unilateral |
Primary outcome
Change in Mean Completion Time for Timed Test
Time frame: Baseline and 3 weeks (immediately post intervention)
Time to complete movement to 16 randomized targets
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35320135Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22.
- Individual participant dataSharing planned: No
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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.
Elliot Roth, MD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral and Unilateral in people with Stroke and Weakness, Muscle, run by Shirley Ryan AbilityLab 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 2 inclusion and 4 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 20 Mar 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?
Yes. Results are posted in the registry (first posted 20 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Mean Completion Time for Timed Test (time frame: Baseline and 3 weeks (immediately post intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619772, which also lists 1 linked publication.
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 20 Mar 2026.