Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback

NCT03300141 | Enrolling By Invitation

• 1 other identifier: STU00204661
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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. 1.Can the movement of healthy individuals be characterized with error augmented visual feedback and veridical visual feedback?
2. 2.Will error augmented visual feedback or veridical visual feedback result in greater movement ability improvement?
3. 3.Is treatment with the looking glass and leap system feasible with an inpatient population?

Conditions

Stroke; Stroke, Acute; Healthy

Keywords

Upper Extremity; Rehabilitation; Arm; Robotics; Stroke Rehabilitation; Virtual Reality Thearpy

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Upper Extremity Score: Pre to Post/Discharge - Chronic and Acute Arms

  Change in Fugl Meyer score from pre-evaluation to post -evaluation

  1-3 weeks for acute arm; 9 weeks for chronic arm

Secondary Outcomes (4)

• Fugl Meyer Upper Extremity Score: Pre to Follow-up

  4.5 months

• Amount of use

  1-3 weeks, on average

• Action Research Arm Test Score: Pre to Post

  1-3 weeks for acute arm; 9 weeks for chronic arm

• Action Research Arm Test Score: Pre to Follow-Up

  4.5 months

Study Arms (5)

Healthy

ACTIVE COMPARATOR

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

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.

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.

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.

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.

Other: Augmented Visual Feedback

Interventions

Veridical Visual Feedback OTHER

Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.

Also known as: Reaching

Acute Veridical Visual Feedback; Chronic Veridical Visual Feedback

Augmented Visual Feedback OTHER

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.

Also known as: Reaching, Error Augmentation

Acute Augmented Visual Feedback; Chronic Augmented Visual Feedback

Healthy Comparative Reaching Task OTHER

Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.

Also known as: Healthy Reaching

Healthy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60610, United States

Location

Related Publications (1)

• 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.

  PMID: 40781976 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James Patton

  Shirley Ryan AbilityLab and University of Illinois at Chicago (UIC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: October 3, 2017
• Study Start: August 8, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-09

Locations

US (1)