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Action Observation as a Rehabilitation Intervention for Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Action observation
Sponsored by
Georgia State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke experienced at 18 years of age or older
  • not undergoing any physical rehabilitation during the time enrolled in this study
  • mild to moderate impairments in the more affected arm and hand (i.e., movement and coordination scores on the Fugl-Meyer Assessment between 20 and 55)
  • no cognitive impairments (mini-mental state examination ≥ 24/30)
  • normal or corrected vision (National Institutes of Health Stroke Scale = 0)

Exclusion Criteria:

  • any uncorrected impairment to the visual field, such as spatial neglect or inattention (i.e., decreased awareness/perception of objects or people in a section of the visual field) (National Institutes of Health Stroke Scale > 1)
  • inability to communicate and participate effectively for assessments and intervention sessions (mini-mental state examination and National Institutes of Health Stroke Scale) upper arm and hand movement impairment that is severe (Fugl-Meyer Assessment < 20) or non-existent (Fugl-Meyer Assessment > 55)

Sites / Locations

  • Georgia Tech

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Action observation

Arm Description

Outcomes

Primary Outcome Measures

Eye gaze pattern
Eye gaze patterns will be collected with a Pupil Labs Eye Camera (Berlin, Germany; 200 Hz, binocular) throughout the experiment. The participants will don eye tracking glasses that feature two pupil cameras which track the participants' pupils relative to the world, which records what participants see in their line of vision. Eye gaze will identify areas of interest of the SRTT (movement task).
Arm and hand movement with the Serial Reaction Time Test (SRTT)
The participants' arm and hand movement will be analyzed when the participants perform the SRTT action using a Sensor Ascension trakSTAR system (Motion Monitor, Chicago). Electromagnetic sensors (MotionMonitor, Chicago) will be placed at key locations on the participant's arm and hand that they are using to complete the SRTT.

Secondary Outcome Measures

Full Information

First Posted
August 3, 2021
Last Updated
May 31, 2023
Sponsor
Georgia State University
Collaborators
Georgia Institute of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05001958
Brief Title
Action Observation as a Rehabilitation Intervention for Stroke
Official Title
Understanding the Mechanisms of Action Observation as a Rehabilitation Intervention for Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgia State University
Collaborators
Georgia Institute of Technology

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
One way to help a stroke survivor learn how to use their arm and hand again is to have them watch and replicate "normal" arm and hand movements. This type of intervention is called action observation (AO) and has emerged as a potentially powerful therapeutic tool to improve stroke rehabilitation for the weakened arm and hand. AO involves the patient's visual observation of video recorded intact body movements with the intent to perform the same task with their weakened arm and hand. There is behavioral evidence in stroke survivors that movement skills usually gained through physical practice can also be acquired through observation of the skill alone. In preliminary research performed in Dr. Lewis Wheaton's lab at Georgia Tech, AO has been successfully implemented for persons with arm and hand amputations learning how to use their prostheses. AO training in patients with amputations revealed that their movement is improved when they focus their eye gaze on specific aspects of the movement in the video that may maximally benefit the patient. It is unknown if these eye gaze patterns may serve as the mechanism behind AO and differ among those with mild or moderate movement impairments due to stroke. In this study, the investigators seek to identify if experience with AO in stroke survivors with varying levels of impairment has a similar emergence of eye gaze patterns found in people with amputations. The investigators hypothesize that AO augments visuomotor strategies to help support improved movement and enhance rehabilitation strategies in stroke survivors with mild and moderate impairments. The goal of this work is to utilize eye gaze tracking approaches to understand this phenomenon. In addition, the investigators will identify the feasibility of implementing and assessing AO on eye gaze in stroke survivors.
Detailed Description
Arm and hand impairments after stroke significantly limit daily activities and negatively impact quality of life. Action observation (AO) has emerged as a potentially powerful therapeutic intervention to improve stroke rehabilitation for the weakened arm and hand. AO involves the patient's visual observation of video recorded intact body movements from a non-disabled actor with the intent to perform the same skill task. There is behavioral evidence in stroke survivors that movement skills usually acquired through physical practice can also be acquired through observation of the movement skill alone. In preliminary research performed in Dr. Lewis Wheaton's lab at Georgia Tech, AO has been successfully implemented for persons with arm and hand amputations learning how to use their prostheses. Where the patient focuses their eye gaze on the video being observed has been shown to be key in improving their movement. That is, improved movement is associated with specific eye gaze patterns focused movement strategies observed in the non-disabled actor. It is unknown if these mechanisms of eye gaze patterns are also exhibited in stroke survivors, or if they are differentiated between those with varying levels of movement impairment. In this study, the investigators seek to identify if experience with AO in stroke survivors influences a similar emergence of gaze patterns found in people with amputations. In addition, the investigators seek to explore the differences in eye gaze and movement in stroke survivors who exhibit either mild or moderate impairments. The expected outcome of finding eye gaze strategy patterns that are most beneficial in improving movement of the arm and hand after stroke can enhance the implementation of AO by instructing participants with guided cuing to focus on specific areas of interest in the videos. Twenty participants with either mild or moderate weakness in their arm and hand due to stroke will complete the AO intervention with eye gaze and movement assessments. The goal of this work is to implement eye-tracking approaches to understand how AO augments visuomotor strategies (i.e., the mechanism) to help improve movement and enhance rehabilitation strategies in stroke survivors with varying levels of impairments. Aim 1: Evaluate how AO influences eye gaze strategies in stroke survivors as a function of stroke severity. Hypothesis: There are eye gaze pattern strategies in stroke survivors that differ between those with mild and moderate movement impairments. Eye gaze pattern strategies will be assessed during AO, i.e., while watching the videos between participants that are mildly and moderately impaired. Aim 2: Evaluate the relationship between eye gaze strategies and arm and hand movement in stroke survivors as a function of stroke severity. Hypothesis: AO influences the relationship of arm and hand movement with varying gaze pattern strategies in stroke survivors with mild or moderate movement impairments. Arm and hand functional movement will be assessed following AO between participants that are mildly and moderately impaired. Aim 3: Identify the feasibility of implementing and assessing AO in stroke survivors. Hypothesis: There are specific factors that facilitate or hinder the recruitment, retention, and completion of this protocol. Feasibility of this protocol will be assessed to provide guidance for future research efforts in the stroke population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action observation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Action observation
Intervention Description
Participants will view a video of a task performed by a non-disabled actor and then the participants perform the task from the video with their weaker arm & hand.
Primary Outcome Measure Information:
Title
Eye gaze pattern
Description
Eye gaze patterns will be collected with a Pupil Labs Eye Camera (Berlin, Germany; 200 Hz, binocular) throughout the experiment. The participants will don eye tracking glasses that feature two pupil cameras which track the participants' pupils relative to the world, which records what participants see in their line of vision. Eye gaze will identify areas of interest of the SRTT (movement task).
Time Frame
Eye gaze recorded in one day during the 3 blocks of video watching (action observation)
Title
Arm and hand movement with the Serial Reaction Time Test (SRTT)
Description
The participants' arm and hand movement will be analyzed when the participants perform the SRTT action using a Sensor Ascension trakSTAR system (Motion Monitor, Chicago). Electromagnetic sensors (MotionMonitor, Chicago) will be placed at key locations on the participant's arm and hand that they are using to complete the SRTT.
Time Frame
Arm and hand movement recorded in one day during the 3 blocks of physical performance of the SRTT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke experienced at 18 years of age or older not undergoing any physical rehabilitation during the time enrolled in this study mild to moderate impairments in the more affected arm and hand (i.e., movement and coordination scores on the Fugl-Meyer Assessment between 20 and 55) no cognitive impairments (mini-mental state examination ≥ 24/30) normal or corrected vision (National Institutes of Health Stroke Scale = 0) Exclusion Criteria: any uncorrected impairment to the visual field, such as spatial neglect or inattention (i.e., decreased awareness/perception of objects or people in a section of the visual field) (National Institutes of Health Stroke Scale > 1) inability to communicate and participate effectively for assessments and intervention sessions (mini-mental state examination and National Institutes of Health Stroke Scale) upper arm and hand movement impairment that is severe (Fugl-Meyer Assessment < 20) or non-existent (Fugl-Meyer Assessment > 55)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica T Rowe, PhD, OTR/L
Organizational Affiliation
Georgia State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Tech
City
Atlanta
State/Province
Arkansas
ZIP/Postal Code
30332
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Action Observation as a Rehabilitation Intervention for Stroke

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