StrokeEarly Phase 1BimanualNCT03755076
Perceptual-motor Interaction to Improve Bimanual Coordination After Stroke
A Early Phase 1 study testing Perceptual cuing in people with Stroke, run by Albert Einstein Healthcare Network at 1 site in United States.
Trial summary
Significant difficulty in incorporating the weaker arm in daily activities after stroke is, in part, driven by difficulty in engaging both arms interactively in a coordinated manner. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Perceptual cuing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2019to 3 Jan 2024
- Phase
- Early Phase 1
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of unilateral stroke
- ability to reach along a diagonal direction at least 80% of their arm length while fully supported on a frictionless surface and trunk constrained.
- Mini-mental scale score > 26, OR s score of 4 or above on auditory verbal comprehension part of the Western Aphasia Battery to ensure intact comprehension and following commands.
- no evidence of hemispatial neglect tested by a line bisection test.
Who cannot join
- bilateral stroke,
- complete paralyses,
- basal ganglia/cerebellar stroke,
- pain or stiffness in upper extremity that will interfere with the task or inability to follow task instructions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Moss Rehabilitation Research Institute
Elkins Park, Pennsylvania, 19027
About this study
Significant difficulty in incorporating the weaker arm in daily activities after stroke is, in part, driven by difficulty in engaging both arms interactively in a coordinated manner.
The current study aims to determine the nature of bimanual coordination deficits after stroke and takes initial steps to test a novel theory-driven approach to improve interactive bimanual coordination in patients with stroke. This project will advance stroke rehabilitation by identifying novel, scientifically-based strategies to improve the engagement of the weaker arm in coordinated and interactive bimanual actions of daily life, thus improving quality of life in individuals after stroke.
Read the detailed description
Specific Aim: Determine the immediate effects of perceptual cues on bimanual coordination in stroke survivors.
Rationale: Bimanual performance after stroke is impaired and demonstrate two principal deficits: (a) impaired spatiotemporal coordination between the two arms and (b) reduced engagement of the paretic arm. Perceptual cuing often overrides motor execution constraints to influence bimanual coordination in healthy individuals, and help improve performance. Our aim is to determine the immediate effects of specific perceptual cues on bimanual coordination in common-goal bimanual action in participants with stroke. The perceptual cue conditions are (a) indiscriminate: no specific feedback, (b) altered gain: paretic arm gain was reduced such that the paretic arm had to contribute more compared to the nonparetic arm, (c) coordination cue provided as feedback of the horizontal tilt of the common goal, (d) Dual: altered gain of the paretic arm combined with the coordination cue. Our working hypothesis is that time-lag feedback will constrain the two arms to move simultaneously, shorten the time-lag and increase CCr. Further, greater movement weighting applied to the weaker arm to increase the engagement of the weaker arm toward the bimanual action may impair bimanual coordination immediately.
Overall materials and methods: The proposed experiments will follow the general pattern we have used in previous behavioral psychophysical studies in individuals with and without stroke. A controlled virtual environment that records kinematics of the arm and allows real-time movement interaction with a virtual motor task will be used. A program integrating motion capture system (Acsention Technology TrakSTAR) and MATLAB-based GUI-gaming environment allows tracking of the two arms, experimenter-control for specific manipulation such as position of the virtual brick, target gap, relative contribution of the arms and mapping of each arm movement to the movement of the virtual brick to provide real-time and post-response feedback. Participants will be seated in an adjustable chair facing a computer monitor with their trunk constrained to the chair. Their arms will be completely supported on a low friction table top and free to move in the horizontal (X-Y) plane with minimal resistance. An opaque screen will occlude participants' direct vision of their arms. Magnetic markers will be secured to their hands just proximal to the wrist joint and the position of the markers mapped to a virtual brick shown on the computer screen. The motor task is to move the virtual brick(s) to a virtual target gap(s) on the computer screen by moving both arms in 2D (X-Y) plane on the low-friction table. While real-time visual feedback of the brick is available, the brick cannot be felt haptically. From a perceptual perspective, in independent goal condition, each arm moves its own virtual brick to the target gap. In common-goal condition, a common brick was moved on the computer screen to a target window by predetermined weighting of each arm movement.
Prior to beginning the experiments, participants will reach with the paretic arm in three different directions (135º, 90º and 45º relative to the horizontal) to record the maximum reaching distance for two trials in each direction. The minimum reach distance across the three directions will be used to calibrate the start and end position of the target gaps. The target window position will be placed at 90% of the maximum reach distance, oriented at 90º relative to the horizontal.
Procedures: Participants will come to the laboratory for a baseline evaluation to determine eligibility to participate in the experimental protocol. During this baseline evaluation, we will perform the following tests: (1) Fugl-Meyer Examination, (2) Mini-mental scale, (3) Tests for hemineglect using a line-bisection test, (4) Western Aphasia Battery for patients with Aphasia (5) TMS safety questionnaire, (6) MRI safety questionnaire, (7) Box and Block test as well as (8) Penn Neurocognitive assessment.
In the present study, we will test the effect of two different perceptual cues on bimanual coordination. Participants will be instructed to "move" a common virtual brick with both arms to the target windows at 90 degree position without tilting the brick within a target MT of 800 milliseconds- 1.2 seconds. Participants will complete four 60-trial blocks a pseudorandom order. Each block will consist 60 trials of a distinct perceptual cueing condition depending upon the nature of perceptual cues provided.
Condition 1: Indiscriminate: This condition will be similar to the common-goal bimanual condition in Aim 1 where they will transport a common virtual block fixed in a horizontal position to three targets in pseudorandom order. The movement of the bar will be an unweighted average of the two arm movements; i.e., each arm will contribute to 50% of the virtual bar movement (50-50 weighting).
Condition 2: Altered gain: This condition will be similar to Condition 1 (block fixed in horizontal position), but the arm weighting will be differential. The paretic arm will have reduced gain such that it will have to move farther to move the virtual brick with this cue than without it.
Condition 3: Coordination cue: the weighting coefficients of the two arms will be equal (i.e. 50-50); and the virtual brick will tilt in the direction of the lagging arm proportional to the relative time-lag between arms. Operational definition of relative time-lag: Relative time-lag is different than absolute time lag. Relative time-lagis the time-lag between the relative timing of each arm within its trajectory. To illustrate, if the left and right arm are contributing to 70 and 30% of the brick movement, relative time-lag at mid-movement will be zero if the left and right arm have covered half of their respective trajectories. Therefore, relative time-lag is influenced by temporal as well as spatial component of the movement of each arm. Concurrent and post-response feedback about the tilt and path of the virtual brick will be provided after each trial.
Condition 4: Dual cues combining altered gain with coordination cue: In addition to the coordination cue (i.e. "tilt" feedback about the relative time-lag), the paretic arm will have reduced gain such that it will have to move farther and faster to keep the virtual brick horizontal.
- Conditions
- Stroke
- Being tested
- Perceptual cuing
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual cuingBehavioural
Participants were provided four perceptual cues (or feedback) in a pseudorandom order: (a) indiscriminate, (b) Altered gain, (c) Coordination, (d) Dual: altered gain and coordination
| Study group | Role | What they receive |
|---|---|---|
| Neurotypical Control | Experimental | Neurotypical healthy age-matched controls. Receives: Behavioral: Perceptual cuing |
| Stroke survivor | Experimental | Stroke survivors with mild-to-moderate motor impairments Receives: Behavioral: Perceptual cuing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Cross-correlation Coefficient
Cross-correlation between tangential velocity profiles of the two hands was used to index spatial and temporal coordination between hands. Cross-correlation measures similarities of two distinct time series as a function of the displacement of one relative to the other. Repeated correlations between the two hand velocity profiles were obtained as the velocity profile of one hand was successively lagged. The maximum cross correlation coefficient obtained gave a measure of similarity between the two profiles, indexing spatial coordination. The better the arms moved in space, the higher the score they got, called the cross-correlation coefficient (CCr). CCr values range from zero to 1; with values close to 1 means the arms were moving very well together.
Measured: After 20 minutes of training under each perceptual cue condition
Between Hands Time-lag
Temporal coordination is about how well both arms move at the same time. Temporal coordination was quantified as the time lag at which the peak cross-correlation coefficient was obtained via cross-correlation analysis. If one arm moves a little later than the other, there's a time delay (or time lag). Shorter the delay, the better the timing between the arms. If the delay is positive, it means the weaker or less-used arm is moving after the stronger one.
Measured: After 20 minutes of training under each perceptual cue condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start19 Apr 2019
- Primary completion3 Jan 2024
- Study completion3 Jan 2024
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Participants will perform bilateral arm movements in a virtual reality environment under different perceptual conditions to identify a condition that improves coordination between arms.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Shailesh Kantak, Albert Einstein Healthcare Network
- Investigators
- Shailesh S Kantak, PhD, PT, Principal investigator, Moss Rehabilitation Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755076
- Sponsor's protocol ID
- 1 R01 HD095992-01A1
- Other IDs
- R01HD092481
- Acronym
- Bimanual
- Status last verified
- Jul 2025
- First submitted
- 25 Oct 2018
- Last updated
- 14 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual-motor Interaction to Improve Bimanual Coordination After Stroke
- ClinicalTrials.gov ID
- NCT03755076
- Acronym / sponsor ID
- Bimanual / 1 R01 HD095992-01A1
- Conditions
- Stroke
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 3 Jan 2024 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 27 Nov 2018 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Significant difficulty in incorporating the weaker arm in daily activities after stroke is, in part, driven by difficulty in engaging both arms interactively in a coordinated manner.
The current study aims to determine the nature of bimanual coordination deficits after stroke and takes initial steps to test a novel theory-driven approach to improve interactive bimanual coordination in patients with stroke. This project will advance stroke rehabilitation by identifying novel, scientifically-based strategies to improve the engagement of the weaker arm in coordinated and interactive bimanual actions of daily life, thus improving quality of life in individuals after stroke.
Detailed description
Specific Aim: Determine the immediate effects of perceptual cues on bimanual coordination in stroke survivors.
Rationale: Bimanual performance after stroke is impaired and demonstrate two principal deficits: (a) impaired spatiotemporal coordination between the two arms and (b) reduced engagement of the paretic arm. Perceptual cuing often overrides motor execution constraints to influence bimanual coordination in healthy individuals, and help improve performance. Our aim is to determine the immediate effects of specific perceptual cues on bimanual coordination in common-goal bimanual action in participants with stroke. The perceptual cue conditions are (a) indiscriminate: no specific feedback, (b) altered gain: paretic arm gain was reduced such that the paretic arm had to contribute more compared to the nonparetic arm, (c) coordination cue provided as feedback of the horizontal tilt of the common goal, (d) Dual: altered gain of the paretic arm combined with the coordination cue. Our working hypothesis is that time-lag feedback will constrain the two arms to move simultaneously, shorten the time-lag and increase CCr. Further, greater movement weighting applied to the weaker arm to increase the engagement of the weaker arm toward the bimanual action may impair bimanual coordination immediately.
Overall materials and methods: The proposed experiments will follow the general pattern we have used in previous behavioral psychophysical studies in individuals with and without stroke. A controlled virtual environment that records kinematics of the arm and allows real-time movement interaction with a virtual motor task will be used. A program integrating motion capture system (Acsention Technology TrakSTAR) and MATLAB-based GUI-gaming environment allows tracking of the two arms, experimenter-control for specific manipulation such as position of the virtual brick, target gap, relative contribution of the arms and mapping of each arm movement to the movement of the virtual brick to provide real-time and post-response feedback. Participants will be seated in an adjustable chair facing a computer monitor with their trunk constrained to the chair. Their arms will be completely supported on a low friction table top and free to move in the horizontal (X-Y) plane with minimal resistance. An opaque screen will occlude participants' direct vision of their arms. Magnetic markers will be secured to their hands just proximal to the wrist joint and the position of the markers mapped to a virtual brick shown on the computer screen. The motor task is to move the virtual brick(s) to a virtual target gap(s) on the computer screen by moving both arms in 2D (X-Y) plane on the low-friction table. While real-time visual feedback of the brick is available, the brick cannot be felt haptically. From a perceptual perspective, in independent goal condition, each arm moves its own virtual brick to the target gap. In common-goal condition, a common brick was moved on the computer screen to a target window by predetermined weighting of each arm movement.
Prior to beginning the experiments, participants will reach with the paretic arm in three different directions (135º, 90º and 45º relative to the horizontal) to record the maximum reaching distance for two trials in each direction. The minimum reach distance across the three directions will be used to calibrate the start and end position of the target gaps. The target window position will be placed at 90% of the maximum reach distance, oriented at 90º relative to the horizontal.
Procedures: Participants will come to the laboratory for a baseline evaluation to determine eligibility to participate in the experimental protocol. During this baseline evaluation, we will perform the following tests: (1) Fugl-Meyer Examination, (2) Mini-mental scale, (3) Tests for hemineglect using a line-bisection test, (4) Western Aphasia Battery for patients with Aphasia (5) TMS safety questionnaire, (6) MRI safety questionnaire, (7) Box and Block test as well as (8) Penn Neurocognitive assessment.
In the present study, we will test the effect of two different perceptual cues on bimanual coordination. Participants will be instructed to "move" a common virtual brick with both arms to the target windows at 90 degree position without tilting the brick within a target MT of 800 milliseconds- 1.2 seconds. Participants will complete four 60-trial blocks a pseudorandom order. Each block will consist 60 trials of a distinct perceptual cueing condition depending upon the nature of perceptual cues provided.
Condition 1: Indiscriminate: This condition will be similar to the common-goal bimanual condition in Aim 1 where they will transport a common virtual block fixed in a horizontal position to three targets in pseudorandom order. The movement of the bar will be an unweighted average of the two arm movements; i.e., each arm will contribute to 50% of the virtual bar movement (50-50 weighting).
Condition 2: Altered gain: This condition will be similar to Condition 1 (block fixed in horizontal position), but the arm weighting will be differential. The paretic arm will have reduced gain such that it will have to move farther to move the virtual brick with this cue than without it.
Condition 3: Coordination cue: the weighting coefficients of the two arms will be equal (i.e. 50-50); and the virtual brick will tilt in the direction of the lagging arm proportional to the relative time-lag between arms. Operational definition of relative time-lag: Relative time-lag is different than absolute time lag. Relative time-lagis the time-lag between the relative timing of each arm within its trajectory. To illustrate, if the left and right arm are contributing to 70 and 30% of the brick movement, relative time-lag at mid-movement will be zero if the left and right arm have covered half of their respective trajectories. Therefore, relative time-lag is influenced by temporal as well as spatial component of the movement of each arm. Concurrent and post-response feedback about the tilt and path of the virtual brick will be provided after each trial.
Condition 4: Dual cues combining altered gain with coordination cue: In addition to the coordination cue (i.e. "tilt" feedback about the relative time-lag), the paretic arm will have reduced gain such that it will have to move farther and faster to keep the virtual brick horizontal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will perform bilateral arm movements in a virtual reality environment under different perceptual conditions to identify a condition that improves coordination between arms.
| Arm | Type | Receives |
|---|---|---|
| Neurotypical Control | Experimental | Behavioral: Perceptual cuingNeurotypical healthy age-matched controls. |
| Stroke survivor | Experimental | Behavioral: Perceptual cuingStroke survivors with mild-to-moderate motor impairments |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of unilateral stroke
- ability to reach along a diagonal direction at least 80% of their arm length while fully supported on a frictionless surface and trunk constrained.
- Mini-mental scale score > 26, OR s score of 4 or above on auditory verbal comprehension part of the Western Aphasia Battery to ensure intact comprehension and following commands.
- no evidence of hemispatial neglect tested by a line bisection test.
Key exclusion criteria (4 listed)
- bilateral stroke,
- complete paralyses,
- basal ganglia/cerebellar stroke,
- pain or stiffness in upper extremity that will interfere with the task or inability to follow task instructions.
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 |
|---|---|---|
| Perceptual cuingParticipants were provided four perceptual cues (or feedback) in a pseudorandom order: (a) indiscriminate, (b) Altered gain, (c) Coordination, (d) Dual: altered gain and coordination | Behavioural | Neurotypical Control, Stroke survivor |
Primary outcome
Maximum Cross-correlation Coefficient
Time frame: After 20 minutes of training under each perceptual cue condition
Cross-correlation between tangential velocity profiles of the two hands was used to index spatial and temporal coordination between hands. Cross-correlation measures similarities of two distinct time series as a function of the displacement of one relative to the other. Repeated correlations between the two hand velocity profiles were obtained as the velocity profile of one hand was successively lagged. The maximum cross correlation coefficient obtained gave a measure of similarity between the two profiles, indexing spatial coordination. The better the arms moved in space, the higher the score they got, called the cross-correlation coefficient (CCr). CCr values range from zero to 1; with values close to 1 means the arms were moving very well together.
Between Hands Time-lag
Time frame: After 20 minutes of training under each perceptual cue condition
Temporal coordination is about how well both arms move at the same time. Temporal coordination was quantified as the time lag at which the peak cross-correlation coefficient was obtained via cross-correlation analysis. If one arm moves a little later than the other, there's a time delay (or time lag). Shorter the delay, the better the timing between the arms. If the delay is positive, it means the weaker or less-used arm is moving after the stronger one.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
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.
Shailesh S Kantak, PhD, PT principal investigator
Moss Rehabilitation Research Institute
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 Perceptual cuing in people with Stroke, run by Albert Einstein Healthcare Network 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 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 14 Aug 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?
Yes. Results are posted in the registry (first posted 14 Aug 2025). 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?
Maximum Cross-correlation Coefficient (time frame: After 20 minutes of training under each perceptual cue condition). The study lists 2 primary outcomes in all. 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 14 Aug 2025.