- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03300141
Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Courtney Celian, MSOT
- Phone Number: 312-238-1560
- Email: ccelian@sralab.org
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60610
- Recruiting
- Shirley Ryan AbilityLab
-
Contact:
- Courtney Celian, MSOT
- Phone Number: 312-238-1560
- Email: ccelian@sralab.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy
Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system
|
Reaching while sitting at the Looking Glass system.
This will occur over the course of 1 hour.
Other Names:
|
Experimental: Chronic Veridical Visual Feedback
Reaching while sitting at the Looking Glass system.
The representation of arm movements will directly reflect the participants actual arm movements.
|
Reaching while sitting at the Looking Glass system.
The representation of arm movements will directly reflect the participants actual arm movements.
Other Names:
|
Experimental: Chronic Augmented Visual Feedback
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.
|
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.
Other Names:
|
Experimental: Acute Veridical Visual Feedback
Reaching while sitting at the Looking Glass system.
The representation of arm movements will directly reflect the participants actual arm movements.
|
Reaching while sitting at the Looking Glass system.
The representation of arm movements will directly reflect the participants actual arm movements.
Other Names:
|
Experimental: Acute Augmented Visual Feedback
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1-3 weeks for acute arm; 9 weeks for chronic arm
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl Meyer Upper Extremity Score: Pre to Follow-up
Time Frame: 4.5 months
|
Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm
|
4.5 months
|
Amount of use
Time Frame: 1-3 weeks, on average
|
Time spent in treatment - Acute Arm
|
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
|
Change in Action Research Arm Test score from pre-evaluation to post -evaluation: Chronic and Acute Arms
|
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
|
Change in Action Research Arm Test score from pre-evaluation to Follow-up -evaluation: Chronic Arm
|
4.5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Patton, Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00204661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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