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Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback

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ClinicalTrials.gov Identifier: NCT03300141
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : October 8, 2018
Sponsor:
Information provided by (Responsible Party):
James Patton, Shirley Ryan AbilityLab

Brief 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.

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:

  1. Can the movement of healthy individuals be characterized with error augmented visual feedback and veridical visual feedback?
  2. 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.

  3. 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.


Condition or disease Intervention/treatment Phase
Stroke Stroke, Acute Healthy Other: Veridical Visual Feedback Other: Augmented Visual Feedback Other: Healthy Comparative Reaching Task Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bimanual Balanced Reaching With Visual Biofeedback
Actual Study Start Date : August 8, 2017
Estimated Primary Completion Date : March 8, 2019
Estimated Study Completion Date : November 8, 2021

Arm Intervention/treatment
Active Comparator: Healthy
Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system
Other: Healthy Comparative Reaching Task
Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.
Other Name: Healthy Reaching

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.
Other: Veridical Visual Feedback
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Other Name: Reaching

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.
Other: 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.
Other Names:
  • Reaching
  • Error Augmentation

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.
Other: Veridical Visual Feedback
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Other Name: Reaching

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.
Other: 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.
Other Names:
  • Reaching
  • Error Augmentation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Amount of use [ Time Frame: 1-3 weeks, on average ]
    Time spent in treatment - Acute Arm

  3. 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300141


Contacts
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Contact: Kelly Thielbar, MSOT 312-238-1288 kthielbar@sralab.org
Contact: Caitlin Doman 312-238-1288 cdoman@sralab.org

Locations
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United States, Illinois
Shirley Ryan AbilityLab Recruiting
Chicago, Illinois, United States, 60610
Contact: Kelly Thielbar, MSOT    312-238-1288    kthielbar@sralab.org   
Contact: Caitlin Doman    312-238-1288    cdoman@sralab.org   
Sponsors and Collaborators
Shirley Ryan AbilityLab
Investigators
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Principal Investigator: James Patton Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)

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Responsible Party: James Patton, Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT03300141     History of Changes
Other Study ID Numbers: STU00204661
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by James Patton, Shirley Ryan AbilityLab:
Upper Extremity
Rehabilitation
Arm
Robotics
Stroke Rehabilitation
Virtual Reality Thearpy

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases