StrokeEarly Phase 1NCT06656754
R01.Aim 2.Study 1: IsoReach
A Early Phase 1 study testing Isometric Reaching in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Isometric Reaching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2024to 1 May 2029
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old
- No history of stroke
- Ability to provide informed consent .
- 18 years old
- Chronic stroke (8+ months post)
- Available medical records and radiographic information about lesion locations
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- Hemiparesis
- Primary motor cortex involvement
- Some degree of both shoulder and elbow movement capability
Who cannot join
- Severe medical problems (including cardiovascular, orthopedic, or neurological)
- Medical problems affecting movement, range of motion, strength, or coordination of the upper extremities.
- Visual deficits that would influence the ability to perform the experiment . This will be assessed using the following assessments:
- Visual field deficits will be assessed using the BIVABA acuity testing. (cutoff score \> 20/100)
- Depth perception deficits will be assessed using the Stereofly test (require at least an angle of stereopsis at 16 inches is 3,552 seconds of arc).
- 4) Blood pressure above 140 systolic and/or 90 diastolic mmHG
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- 5) Blood oxygen reading of less than 92% by finger pulse oximeter testing.
- Bilateral paresis
- Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment, This will be assessed using the Mini Mental State Examination31, with cut-off scores (adjusted for education level) as follows:
- Participants whose education are 7th grade or lower, a score 22 or lower
- Participants whose education attainment level is 8th grade or some high school (but not a graduate), a score of 24 or lower
- Participants whose education attainment level is high school graduate, a score of 25 or lower
- Participants whose education attainment level is some college or higher, a score 26 or lower
- Visual deficits, and hemispatial neglect that would prevent the participants from seeing the targets. A vision test will be done if the participant indicates in their screen that their stroke has affected their vision. This will be tested using the following assessments:
- Visual field loss will be assessed using the BIVABA acuity test10. (cutoff score \> 20/100)
- Visual Extinction and Inattention using Star Cancellation Test9. (cutoff score of \<44)
- Depth perception deficits will be assessed using the Stereofly test (require at least an angle of stereopsis at 16 inches is 3,552 seconds of arc).
- Modified Ashworth score of 4 at shoulder or elbow joints.
- Rated below 15 on the FMUE scale
- Inability to provide an informed consent
- severe current medical problems
- Severe sensory deficit in the affected limb (Cannot be absent in any part of affected UE)
- diffuse/multiple lesion sites or multiple stroke events
- Inability to attain and maintain testing positions
- Botox or other botulinum toxin injection to the affected upper extremity within the previous 4 months
- Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
- Neurological, neuromuscular, or orthopedic diseases (i.e. injuries to your affected arm or hand)
- Other neurological issues (Parkinson's, CP)
- Blood Pressure above 140 systolic and/or 90 diastolic mmHg
- Blood oxygen reading of less than 92% on finger pulse oximetry testing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Courtney Celian, OTR/L contact
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Courtney Project Manager, 312-238-1560, ccelian@sralab.org
James L Patton, PhD
About this study
Official title: Error-enhanced Learning & Recovery in 2 & 3 Dimensions
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.
Read the detailed description
Researchers have found that neurotypical adults are able to train movement skills when sensory sources, such as proprioception, are altered using isometric conditions and visual feedback in a two-dimensional environment.Building off this knowledge, the investigators plan to apply similar techniques to both neurotypical adults and stroke survivors with impaired movement, but in a three-dimensional environment. The investigators will ask participants to practice a unilateral virtual reality targeted reaching task using a robotic arm in a 3D visual display system mounted over the arm. Participants will be given visual feedback of their arm through a virtual avatar displayed on the screen. First, they will complete unconstrained targeted reaching and then complete targeted reaching with the robotic arm constrained in a fixed position ("isometric" movement). The forces applied to constrain the robotic arm will be translated to the virtual avatar arm on the screen, and it will look as if their arm is moving. The investigators will compare perpendicular errors (maximum difference between the ideal reaching trajectory and the actual) made in unconstrained and constrained movement conditions. The investigators aim to determine if the two movement conditions yield similar error responses when sensory sources are altered in a 3D environment.
- Conditions
- Stroke
- Being tested
- Isometric Reaching
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric ReachingOther
The intervention of "Isometric Reaching" is the process of restricting the participant's hand movement in place, while using the forces they apply to the robot handle to drive a reaching arm simulation
| Study group | Role | What they receive |
|---|---|---|
| Isometric Reaching condition | Experimental | In this arm the participant participates in "Isometric Reaching" in which they are not allowed to freely reach to the target, instead the forces they apply on the robot handle drives a reaching arm simulation Receives: Other: Isometric Reaching |
| Control Reaching condition | No intervention | In this condition the participant moves toward target freely and the visual feedback is based on hand position and not an arm simulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perpendicular Error
Maximum distance between the ideal reaching trajectory and the actual trajectory made in unconstrained and constrained movement conditions
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start17 Nov 2024
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe 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
- Early Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Lanphier Patton, Shirley Ryan AbilityLab
- Investigators
- James L Patton, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656754
- Sponsor's protocol ID
- STU00220740
- Status last verified
- Jan 2025
- First submitted
- 4 Sep 2024
- Last updated
- 9 Jan 2025
- 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Error-enhanced Learning & Recovery in 2 & 3 Dimensions
- ClinicalTrials.gov ID
- NCT06656754
- Acronym / sponsor ID
- STU00220740
- Conditions
- Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 24 Oct 2024 (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.
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.
Detailed description
Researchers have found that neurotypical adults are able to train movement skills when sensory sources, such as proprioception, are altered using isometric conditions and visual feedback in a two-dimensional environment.Building off this knowledge, the investigators plan to apply similar techniques to both neurotypical adults and stroke survivors with impaired movement, but in a three-dimensional environment. The investigators will ask participants to practice a unilateral virtual reality targeted reaching task using a robotic arm in a 3D visual display system mounted over the arm. Participants will be given visual feedback of their arm through a virtual avatar displayed on the screen. First, they will complete unconstrained targeted reaching and then complete targeted reaching with the robotic arm constrained in a fixed position ("isometric" movement). The forces applied to constrain the robotic arm will be translated to the virtual avatar arm on the screen, and it will look as if their arm is moving. The investigators will compare perpendicular errors (maximum difference between the ideal reaching trajectory and the actual) made in unconstrained and constrained movement conditions. The investigators aim to determine if the two movement conditions yield similar error responses when sensory sources are altered in a 3D environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isometric Reaching condition | Experimental | Other: Isometric ReachingIn this arm the participant participates in "Isometric Reaching" in which they are not allowed to freely reach to the target, instead the forces they apply on the robot handle drives a reaching arm simulation |
| Control Reaching condition | No intervention | –In this condition the participant moves toward target freely and the visual feedback is based on hand position and not an arm simulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years old
- No history of stroke
- Ability to provide informed consent .
- Chronic stroke (8+ months post)
- Available medical records and radiographic information about lesion locations
Key exclusion criteria (30 listed)
- Severe medical problems (including cardiovascular, orthopedic, or neurological)
- Medical problems affecting movement, range of motion, strength, or coordination of the upper extremities.
- Visual deficits that would influence the ability to perform the experiment . This will be assessed using the following assessments:
- Visual field deficits will be assessed using the BIVABA acuity testing. (cutoff score \> 20/100)
- Depth perception deficits will be assessed using the Stereofly test (require at least an angle of stereopsis at 16 inches is 3,552 seconds of arc).
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 |
|---|---|---|
| Isometric ReachingThe intervention of "Isometric Reaching" is the process of restricting the participant's hand movement in place, while using the forces they apply to the robot handle to drive a reaching arm simulation | Other | Isometric Reaching condition |
Primary outcome
Perpendicular Error
Time frame: through study completion, an average of 1 year.
Maximum distance between the ideal reaching trajectory and the actual trajectory made in unconstrained and constrained movement conditions
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 9 Jan 2025.
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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.
Courtney Celian, OTR/L contact
James L Patton, PhD 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 Early Phase 1 study testing Isometric Reaching in people with Stroke, 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 9 inclusion and 30 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 9 Jan 2025. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Arturo Ramirez (312-238-1379, aramire4@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perpendicular Error (time frame: through study completion, an average of 1 year.). 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 9 Jan 2025.