search
Back to results

Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback

Primary Purpose

Stroke, Stroke, Acute, Healthy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Veridical Visual Feedback
Augmented Visual Feedback
Healthy Comparative Reaching Task
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Upper Extremity, Rehabilitation, Arm, Robotics, Stroke Rehabilitation, Virtual Reality Thearpy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy

Chronic Veridical Visual Feedback

Chronic Augmented Visual Feedback

Acute Veridical Visual Feedback

Acute Augmented Visual Feedback

Arm Description

Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system

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 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 arm movements will directly reflect the participants actual arm movements.

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.

Outcomes

Primary Outcome Measures

Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms
Change in Fugl Meyer score from pre-evaluation to post -evaluation

Secondary Outcome Measures

Fugl Meyer Upper Extremity Score: Pre to Follow-up
Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm
Amount of use
Time spent in treatment - Acute Arm
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
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

Full Information

First Posted
September 13, 2017
Last Updated
July 25, 2023
Sponsor
Shirley Ryan AbilityLab
search

1. Study Identification

Unique Protocol Identification Number
NCT03300141
Brief Title
Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback
Official Title
Bimanual Balanced Reaching With Visual Biofeedback
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Acute, Healthy
Keywords
Upper Extremity, Rehabilitation, Arm, Robotics, Stroke Rehabilitation, Virtual Reality Thearpy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Active Comparator
Arm Description
Healthy participants will participate in reaching activity using the Looking Glass and Leap motion tracking system
Arm Title
Chronic Veridical Visual Feedback
Arm Type
Experimental
Arm Description
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Arm Title
Chronic Augmented Visual Feedback
Arm Type
Experimental
Arm Description
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.
Arm Title
Acute Veridical Visual Feedback
Arm Type
Experimental
Arm Description
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Arm Title
Acute Augmented Visual Feedback
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Veridical Visual Feedback
Other Intervention Name(s)
Reaching
Intervention Description
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Intervention Type
Other
Intervention Name(s)
Augmented Visual Feedback
Other Intervention Name(s)
Reaching, Error Augmentation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Healthy Comparative Reaching Task
Other Intervention Name(s)
Healthy Reaching
Intervention Description
Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.
Primary Outcome Measure Information:
Title
Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms
Description
Change in Fugl Meyer score from pre-evaluation to post -evaluation
Time Frame
1-3 weeks for acute arm; 9 weeks for chronic arm
Secondary Outcome Measure Information:
Title
Fugl Meyer Upper Extremity Score: Pre to Follow-up
Description
Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm
Time Frame
4.5 months
Title
Amount of use
Description
Time spent in treatment - Acute Arm
Time Frame
1-3 weeks, on average
Title
Action Research Arm Test Score: Pre to Post
Description
Change in Action Research Arm Test score from pre-evaluation to post -evaluation: Chronic and Acute Arms
Time Frame
1-3 weeks for acute arm; 9 weeks for chronic arm
Title
Action Research Arm Test Score: Pre to Follow-Up
Description
Change in Action Research Arm Test score from pre-evaluation to Follow-up -evaluation: Chronic Arm
Time Frame
4.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Celian, MSOT
Phone
312-238-1560
Email
ccelian@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Patton
Organizational Affiliation
Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Courtney Celian, MSOT
Phone
312-238-1560
Email
ccelian@sralab.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback

We'll reach out to this number within 24 hrs