Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Recruiting
CT.gov ID
NCT05180786
Collaborator
(none)
20
2
1
8
10
1.3

Study Details

Study Description

Brief Summary

This study is being done to see how errors lead to improvement. Specifically, we are evaluating the errors stroke participants make during an upper extremity exercise program when reaching for a target using their affected arm. Once we understand the participant's reaching errors, we plan to create a customized reaching exercise according to the individual's specific error tendencies which will lead to better performance on movement ability after training.

Condition or Disease Intervention/Treatment Phase
  • Other: customized reaching exercise
Early Phase 1

Detailed Description

The neuroplasticity of motor re-learning is a key pathway for recovery in neurorehabilitation. One critical challenge to devising treatment plans for motor recovery is the wide variation that exists between individuals, across movement repetitions, and even within movements. Development of a learning model that looks at these factors would better relate diagnoses to treatments, providing personalization and efficiency to therapy. This proposal aims to advance rehabilitation by building a modeling framework that explores the trends and exploits a fundamental learning process - error.

We are using research lab equipment at the Shirley Ryan AbilityLab (SRALab) Hospital's Robotics group. The equipment will be used to implement the reaching exercises and measure participant movement. The equipment includes:

  1. Barret b.u.r.t. arm robot with Teneo forearm attachment

  2. LookinGlass display system

  3. LeapTM Sensor tracking tool

Day 1: Participants will undergo a screening and consenting session with a research therapist to assess enrollment eligibility.

Day2: If the participant meets all inclusion/exclusion criteria, they will return and complete a series of upper extremity outcome measures to characterize impairment level.

Day 3 and 4: The participant will then complete 1-2 intervention sessions using the Barret b.u.r.t. arm, LookinGlass display screen, and LeapTM tracking sensor. This intervention study will last anywhere from 15-min-90 min depending the equipment functioning. The intervention will consist of two phases:

  1. Learning Phase to determine the individual's error likelihood

  2. Training Phase to apply determined error likelihood to see if there are any changes in performance

Our goal is to preliminarily test the direct effect of this new treatment in preparation for the randomized controlled study to come. Understanding how error leads to better performance will help us program future devices for therapy for optimal outcomes.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Error-enhanced Learning & Recovery in 2 & 3 Dimensions
Anticipated Study Start Date :
May 1, 2022
Anticipated Primary Completion Date :
Dec 30, 2022
Anticipated Study Completion Date :
Dec 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stroke Participants

Single intervention session

Other: customized reaching exercise
Learning Phase: approximately 15 minutes of a reaching exercise to determine the individual's movement error likelihood Training Phase: approximately 45 minutes of a reaching exercise with a customized model applied that is based upon the participants movement error likelihood.

Outcome Measures

Primary Outcome Measures

  1. Movement errors [60-90 minutes]

    The frequency of errors made during a reaching exercise

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Chronic stroke (at least 8 months post stroke)

  • Available medical records and radiographic information about lesion locations

  • Hemiparesis

  • Some degree of both shoulder and elbow movement

  • A "moderate" impairment of arm function (Fugl-Meyer score between 15-50)

Exclusion Criteria:
  • Bilateral paresis

  • Severe tactile deficits using the Two-Point Discrimination Test

  • Severe Spasticity preventing movement

  • Aphasia, cognitive impairment, or affective dysfunction that would influence ability to perform the experiment

  • Inability to provide informed consent

  • Severe current medical problems

  • Diffuse/multiple lesion sites or multiple stroke events

  • Hemispatial neglect or visual field cut that would prevent subjects from seeing the targets

  • Individuals under the age of 21 will no be included since this study is focused on motor behavior and learning of fully developed nervous system

  • Inability to attain and maintain testing positions

  • Botox injection to the affected upper extremity within the previous 4 months

  • Concurrent participation in upper extremity rehabilitation either as part of a research study intervention protocol or a prescribed therapy

  • Participation in previous, similar robotics intervention study

None of the following special populations will be included in this research study:
  • Adults unable to consent

  • Individuals who are not yet adults (infants, children, teenagers)

  • Pregnant women

  • Prisoners

  • Vulnerable Populations

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shirley Ryan AbilityLab Chicago Illinois United States 60611
2 Shirley Ryan AbilityLab Chicago Illinois United States 60611

Sponsors and Collaborators

  • Shirley Ryan AbilityLab

Investigators

  • Principal Investigator: James Patton, PhD, Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
James Patton, Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier:
NCT05180786
Other Study ID Numbers:
  • STU00215000
First Posted:
Jan 6, 2022
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by James Patton, Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab, Shirley Ryan AbilityLab
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022