Shirley Ryan AbilityLab
Chicago, Illinois, 60610, United States
NCT Number: NCT03300141
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60610, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
Other names: Reaching
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
Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.
Other names: Healthy Reaching
Time frame: 1-3 weeks for acute arm; 9 weeks for chronic arm
Change in Fugl Meyer score from pre-evaluation to post -evaluation
Time frame: 4.5 months
Change in Fugl Meyer score from pre-evaluation to follow-up-evaluation - Chronic Arm
Time frame: 1-3 weeks, on average
Time spent in treatment - Acute Arm
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
Time frame: 4.5 months
Change in Action Research Arm Test score from pre-evaluation to Follow-up -evaluation: Chronic Arm
Shirley Ryan AbilityLab
Other
Bimanual Balanced Reaching With Visual Biofeedback
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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