NCT05001958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

June 1, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

August 3, 2021

Last Update Submit

May 31, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    Eye gaze recorded in one day during the 3 blocks of video watching (action observation)

  • 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.

    Arm and hand movement recorded in one day during the 3 blocks of physical performance of the SRTT

Study Arms (1)

Action observation

EXPERIMENTAL
Behavioral: Action observation

Interventions

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.

Action observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Tech

Atlanta, Arkansas, 30332, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Veronica T Rowe, PhD, OTR/L

    Georgia State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 12, 2021

Study Start

October 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

June 1, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations