Looking Glass: Bimanual Balanced Reaching With Visual Biofeedback

NCT ID: NCT03300141

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-08

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Stroke, Acute Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Healthy

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

Group Type ACTIVE_COMPARATOR

Healthy Comparative Reaching Task

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Veridical Visual Feedback

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Augmented Visual Feedback

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Veridical Visual Feedback

Intervention Type OTHER

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

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.

Group Type EXPERIMENTAL

Augmented Visual Feedback

Intervention Type 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.

Interventions

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Veridical Visual Feedback

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

Intervention Type 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.

Intervention Type OTHER

Healthy Comparative Reaching Task

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

Intervention Type OTHER

Other Intervention Names

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Reaching Reaching Error Augmentation Healthy Reaching

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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James Lanphier Patton

Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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James Patton

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40781976 (View on PubMed)

Other Identifiers

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STU00204661

Identifier Type: -

Identifier Source: org_study_id

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