StrokeNCT03300141
Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback
A study testing Veridical Visual Feedback, Augmented Visual Feedback and Healthy Comparative Reaching Task in people with Stroke and Stroke, Acute, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The goal of this research study is to increase understanding of error augmentation by applying it to visual feedback during motion tracking with a Leap Motion device - a recently developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality environment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Stroke, Acute, Healthy
- What is being tested?
- Veridical Visual Feedback, Augmented Visual Feedback and Healthy Comparative Reaching Task
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to Dec 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 8 months post stroke
- FMUE 15-50
- Active shoulder and elbow flexion-extension when supported against gravity to accomplish a forward mediolateral and inferior-superior reaching movements of 30 cm
Who cannot join
- Bilateral paresis
- Severe sensory deficits in the affected limb
- Severe spasticity preventing movement (MAS 4 or greater at elbow)
- Aphasia, cognitive impairment or affective dysfunction that influence ability to participate in the experiment
- Inability to provide informed consent
- Severe current medical problems
Show all 13Show fewer
- Diffuse/multiple lesion sites or multiple strokes
- Hemi-spatial neglect or visual field cut preventing subjects from seeing the target
- Inability to maintain the testing positions
- Botox injections in the affected Upper Extremity within the past 4 months
- Concurrent participation in Upper Extremity rehab (research or prescribed therapy)
- Participation in previous, similar robotics intervention studies
- Pregnant women, children and teenagers, prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Bimanual Balanced Reaching With Visual Biofeedback
The goal of this research study is to increase understanding of error augmentation by applying it to visual feedback during motion tracking with a Leap Motion device - a recently developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality environment.
In conjunction with the Leap, large, three dimensional work spaces can provide an immersive and virtual augmented environment for rehabilitation. Previously, experiments have utilized the Virtual Reality Robotic and Optical Operations Machine (VRROOM) to create such visually immersive environments. The Robotics lab as part of the Arms and Hands Lab on the 22nd floor of the Shirley Ryan Abilitylab has developed a portable version of this system, which is more compact and clinic-compatible. Combining this visual 3D system with the Leap creates a novel, more capable apparatus for studying error augmentation.
Read more
This research study will have 3 different arms: 1.) a healthy group of individuals (Healthy Arm), 2.) a group of stroke survivors within 8 months of stroke (Acute Arm), and 3.) a group of stroke survivors that had their stroke more than 8 months ago (Chronic Arm).
Each Arm will use the Leap motion tracker and the Looking Glass to participate in a reaching intervention. The healthy arm will only participate in 1 visit with an intervention with and without error augmented visual feedback. The Acute Arm and the Chronic Arm will both have 2 groups: 1.) Error Augmented Visual Feedback group and 2.) Non-Augmented or Veridical Visual Feedback group.
The Chronic Arm will have a structured intervention and evaluation protocol: Study staff will administer outcome assessments at 3 time points: a.) prior to intervention, b.) post intervention, and c.) 2 months after the conclusion of intervention. Intervention will occur over the span of 6-8 weeks with the goal of 3 1-hour sessions per week.
The Acute Arm will have a less structured intervention that will occur while the participant is an inpatient at Shirley Ryan AbilityLab. Study staff will administer outcome assessments at at least 2 time points: a.) prior to intervention, b.) post intervention just prior to discharge from Shirley Ryan AbilityLab. Between initial and post intervention evaluations, midpoint evaluations will take place at a maximum of once per week if the participant's schedule, activity tolerance, and length of stay allows. Intervention will consist of 1-hour sessions occurring according to the availability of the participant at the rate of no more than 2 sessions in a 24 hour period.
Investigators hope to investigate these questions:
- Can the movement of healthy individuals be characterized with error augmented visual feedback and veridical visual feedback?
- Will error augmented visual feedback or veridical visual feedback result in greater movement ability improvement? Investigators hypothesize that in the Chronic Arm, those what trained with error-augmented visual feedback will have improved movement ability compared to those who trained with veridical visual feedback.
- Is treatment with the looking glass and leap system feasible with an inpatient population?
Investigators hypothesize that this treatment will be feasible for an inpatient population.
- Conditions
- Stroke, Stroke, Acute, Healthy
- Being tested
- Veridical Visual Feedback, Augmented Visual Feedback, Healthy Comparative Reaching Task
- Keywords
- Upper Extremity, Rehabilitation, Arm, Robotics, Stroke Rehabilitation, Virtual Reality Thearpy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veridical Visual FeedbackOther
Also called Reaching
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Augmented Visual FeedbackOther
Also called Reaching, Error Augmentation
Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.
Healthy Comparative Reaching TaskOther
Also called Healthy Reaching
Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Active comparator | Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system Receives: Other: Healthy Comparative Reaching Task |
| Chronic Veridical Visual Feedback | Experimental | Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements. Receives: Other: Veridical Visual Feedback |
| Chronic Augmented Visual Feedback | Experimental | Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement. Receives: Other: Augmented Visual Feedback |
| Acute Veridical Visual Feedback | Experimental | Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements. Receives: Other: Veridical Visual Feedback |
| Acute Augmented Visual Feedback | Experimental | Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement. Receives: Other: Augmented Visual Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms
Change in Fugl Meyer score from pre-evaluation to post -evaluation
Measured: 1-3 weeks for acute arm; 9 weeks for chronic arm
Secondary outcomes (4)
Fugl Meyer Upper Extremity Score: Pre to Follow-up
Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm
Measured: 4.5 months
Amount of use
Time spent in treatment - Acute Arm
Measured: 1-3 weeks, on average
Action Research Arm Test Score: Pre to Post
Change in Action Research Arm Test score from pre-evaluation to post -evaluation: Chronic and Acute Arms
Measured: 1-3 weeks for acute arm; 9 weeks for chronic arm
Action Research Arm Test Score: Pre to Follow-Up
Change in Action Research Arm Test score from pre-evaluation to Follow-up -evaluation: Chronic Arm
Measured: 4.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start8 Aug 2017
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 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 Patton, Principal investigator, Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300141
- Sponsor's protocol ID
- STU00204661
- Status last verified
- Sep 2024
- First submitted
- 13 Sep 2017
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Celian C, Puzzi T, Verardi M, Olavarria E, Porta F, Pedrocchi A, Patton JL. Does visual error augmentation offer advantages during bimanual therapy in individuals poststroke? A randomized controlled trial. J Int Med Res. 2025 Aug;53(8):3000605251361115. doi: 10.1177/03000605251361115. Epub 2025 Aug 9.
PubMed 40781976
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bimanual Balanced Reaching With Visual Biofeedback
- ClinicalTrials.gov ID
- NCT03300141
- Acronym / sponsor ID
- STU00204661
- Conditions
- Stroke, Stroke, Acute, Healthy
- Keywords
- Upper Extremity, Rehabilitation, Arm, Robotics, Stroke Rehabilitation, Virtual Reality Thearpy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Oct 2017 (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 goal of this research study is to increase understanding of error augmentation by applying it to visual feedback during motion tracking with a Leap Motion device - a recently developed optical hand tracking tool - and the LookingGlass - a new, portable virtual reality environment.
In conjunction with the Leap, large, three dimensional work spaces can provide an immersive and virtual augmented environment for rehabilitation. Previously, experiments have utilized the Virtual Reality Robotic and Optical Operations Machine (VRROOM) to create such visually immersive environments. The Robotics lab as part of the Arms and Hands Lab on the 22nd floor of the Shirley Ryan Abilitylab has developed a portable version of this system, which is more compact and clinic-compatible. Combining this visual 3D system with the Leap creates a novel, more capable apparatus for studying error augmentation.
This research study will have 3 different arms: 1.) a healthy group of individuals (Healthy Arm), 2.) a group of stroke survivors within 8 months of stroke (Acute Arm), and 3.) a group of stroke survivors that had their stroke more than 8 months ago (Chronic Arm).
Each Arm will use the Leap motion tracker and the Looking Glass to participate in a reaching intervention. The healthy arm will only participate in 1 visit with an intervention with and without error augmented visual feedback. The Acute Arm and the Chronic Arm will both have 2 groups: 1.) Error Augmented Visual Feedback group and 2.) Non-Augmented or Veridical Visual Feedback group.
The Chronic Arm will have a structured intervention and evaluation protocol: Study staff will administer outcome assessments at 3 time points: a.) prior to intervention, b.) post intervention, and c.) 2 months after the conclusion of intervention. Intervention will occur over the span of 6-8 weeks with the goal of 3 1-hour sessions per week.
The Acute Arm will have a less structured intervention that will occur while the participant is an inpatient at Shirley Ryan AbilityLab. Study staff will administer outcome assessments at at least 2 time points: a.) prior to intervention, b.) post intervention just prior to discharge from Shirley Ryan AbilityLab. Between initial and post intervention evaluations, midpoint evaluations will take place at a maximum of once per week if the participant's schedule, activity tolerance, and length of stay allows. Intervention will consist of 1-hour sessions occurring according to the availability of the participant at the rate of no more than 2 sessions in a 24 hour period.
Investigators hope to investigate these questions:
- Can the movement of healthy individuals be characterized with error augmented visual feedback and veridical visual feedback?
- Will error augmented visual feedback or veridical visual feedback result in greater movement ability improvement? Investigators hypothesize that in the Chronic Arm, those what trained with error-augmented visual feedback will have improved movement ability compared to those who trained with veridical visual feedback.
- Is treatment with the looking glass and leap system feasible with an inpatient population?
Investigators hypothesize that this treatment will be feasible for an inpatient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Healthy | Active comparator | Other: Healthy Comparative Reaching TaskHealthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system |
| Chronic Veridical Visual Feedback | Experimental | Other: Veridical Visual FeedbackReaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements. |
| Chronic Augmented Visual Feedback | Experimental | Other: Augmented Visual FeedbackReaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement. |
| Acute Veridical Visual Feedback | Experimental | Other: Veridical Visual FeedbackReaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements. |
| Acute Augmented Visual Feedback | Experimental | Other: Augmented Visual FeedbackReaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 8 months post stroke
- FMUE 15-50
- Active shoulder and elbow flexion-extension when supported against gravity to accomplish a forward mediolateral and inferior-superior reaching movements of 30 cm
Key exclusion criteria (13 listed)
- Bilateral paresis
- Severe sensory deficits in the affected limb
- Severe spasticity preventing movement (MAS 4 or greater at elbow)
- Aphasia, cognitive impairment or affective dysfunction that influence ability to participate in the experiment
- Inability to provide informed consent
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 |
|---|---|---|
| Veridical Visual FeedbackAlso: ReachingReaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements. | Other | Acute Veridical Visual Feedback, Chronic Veridical Visual Feedback |
| Augmented Visual FeedbackAlso: Reaching, Error AugmentationReaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement. | Other | Acute Augmented Visual Feedback, Chronic Augmented Visual Feedback |
| Healthy Comparative Reaching TaskAlso: Healthy ReachingReaching while sitting at the Looking Glass system. This will occur over the course of 1 hour. | Other | Healthy |
Primary outcome
Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms
Time frame: 1-3 weeks for acute arm; 9 weeks for chronic arm
Change in Fugl Meyer score from pre-evaluation to post -evaluation
4 secondary outcomes
Fugl Meyer Upper Extremity Score: Pre to Follow-up
Time frame: 4.5 months
Amount of use
Time frame: 1-3 weeks, on average
Action Research Arm Test Score: Pre to Post
Time frame: 1-3 weeks for acute arm; 9 weeks for chronic arm
Action Research Arm Test Score: Pre to Follow-Up
Time frame: 4.5 months
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 24 Oct 2024.
- Derived from this study: PubMed 40781976Celian C, Puzzi T, Verardi M, Olavarria E, Porta F, Pedrocchi A, Patton JL. Does visual error augmentation offer advantages during bimanual therapy in individuals poststroke? A randomized controlled trial. J Int Med Res. 2025 Aug;53(8):3000605251361115. doi: 10.1177/03000605251361115. Epub 2025 Aug 9.
- Individual participant dataSharing planned: Undecided
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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.
James Patton principal investigator
Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veridical Visual Feedback, Augmented Visual Feedback and Healthy Comparative Reaching Task in people with Stroke and Stroke, Acute, 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 3 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 24 Oct 2024. 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?
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?
Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms (time frame: 1-3 weeks for acute arm; 9 weeks for chronic arm). 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 NCT03300141, 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 24 Oct 2024.