Study Results
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Basic Information
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RECRUITING
NA
65 participants
INTERVENTIONAL
2023-04-11
2026-03-31
Brief Summary
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Detailed Description
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The primary objective is to study the effects of PAT on visuospatial behavior and motor cortical excitability in able-bodied individuals (young and older), and on spatial neglect, motor cortical neurophysiology, and walking function in individuals post-stroke.
The long-term goal of this project is to develop novel, effective, and personalized rehabilitation protocols targeting SN deficits and gait dysfunction to reduce disability in stroke survivors. The rationale of this project is to explore and generate data regarding future novel combinatorial motor-spatial retraining approaches that will enhance the rehabilitation approach of SN and gait performance in individuals post-stroke.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Young Able-Bodied individuals
18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)
PAT requires one to wear prism lenses while making arm-reaching movements toward visual targets. For treating left-sided neglect, a person wears the prism lenses that shift the visual field, including the images of the target and of one's own reaching arm, certain degrees to the right depending on the diopter of the lens (e.g., the 20-diopter lens shifts the visual field by 11.4 degrees). The visual system adapts over the repetitive practice of the arm reaching toward the target. The person eventually achieves success with a leftward movement reaching the actual target. Electrical stimulation (E-stim) involves parameters and settings commonly used in clinical practice as well as research for pain relief and other applications, commonly referred to as transcutaneous electrical nerve stimulation (TENS). TENS and E-stim are delivered using FDA-approved, commercially available portable clinical transcutaneous electrical stimulators (e.g. Empi TENS Unit).
Prism adaptation therapy (PAT) + Sham Stimulator
Participants in the PAT with sham stim condition group will receive sham electrical stimulation treatment (electrodes will be attached but the stimulator will not be turned on) to the left upper limb with the same placement of electrodes while undergoing PAT.
Old Able-Bodied individuals
45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)
PAT requires one to wear prism lenses while making arm-reaching movements toward visual targets. For treating left-sided neglect, a person wears the prism lenses that shift the visual field, including the images of the target and of one's own reaching arm, certain degrees to the right depending on the diopter of the lens (e.g., the 20-diopter lens shifts the visual field by 11.4 degrees). The visual system adapts over the repetitive practice of the arm reaching toward the target. The person eventually achieves success with a leftward movement reaching the actual target. Electrical stimulation (E-stim) involves parameters and settings commonly used in clinical practice as well as research for pain relief and other applications, commonly referred to as transcutaneous electrical nerve stimulation (TENS). TENS and E-stim are delivered using FDA-approved, commercially available portable clinical transcutaneous electrical stimulators (e.g. Empi TENS Unit).
Prism adaptation therapy (PAT) + Sham Stimulator
Participants in the PAT with sham stim condition group will receive sham electrical stimulation treatment (electrodes will be attached but the stimulator will not be turned on) to the left upper limb with the same placement of electrodes while undergoing PAT.
Stroke with Spatial Neglect (SN) individuals
40-90 years individuals with more than 3 months following right hemisphere stroke.
Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)
PAT requires one to wear prism lenses while making arm-reaching movements toward visual targets. For treating left-sided neglect, a person wears the prism lenses that shift the visual field, including the images of the target and of one's own reaching arm, certain degrees to the right depending on the diopter of the lens (e.g., the 20-diopter lens shifts the visual field by 11.4 degrees). The visual system adapts over the repetitive practice of the arm reaching toward the target. The person eventually achieves success with a leftward movement reaching the actual target. Electrical stimulation (E-stim) involves parameters and settings commonly used in clinical practice as well as research for pain relief and other applications, commonly referred to as transcutaneous electrical nerve stimulation (TENS). TENS and E-stim are delivered using FDA-approved, commercially available portable clinical transcutaneous electrical stimulators (e.g. Empi TENS Unit).
Prism adaptation therapy (PAT) + Sham Stimulator
Participants in the PAT with sham stim condition group will receive sham electrical stimulation treatment (electrodes will be attached but the stimulator will not be turned on) to the left upper limb with the same placement of electrodes while undergoing PAT.
Gait Training
After PAT, participants will complete multiple 30-seconds to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts.
Interventions
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Prism adaptation therapy (PAT) + Electrical stimulation (E-stim)
PAT requires one to wear prism lenses while making arm-reaching movements toward visual targets. For treating left-sided neglect, a person wears the prism lenses that shift the visual field, including the images of the target and of one's own reaching arm, certain degrees to the right depending on the diopter of the lens (e.g., the 20-diopter lens shifts the visual field by 11.4 degrees). The visual system adapts over the repetitive practice of the arm reaching toward the target. The person eventually achieves success with a leftward movement reaching the actual target. Electrical stimulation (E-stim) involves parameters and settings commonly used in clinical practice as well as research for pain relief and other applications, commonly referred to as transcutaneous electrical nerve stimulation (TENS). TENS and E-stim are delivered using FDA-approved, commercially available portable clinical transcutaneous electrical stimulators (e.g. Empi TENS Unit).
Prism adaptation therapy (PAT) + Sham Stimulator
Participants in the PAT with sham stim condition group will receive sham electrical stimulation treatment (electrodes will be attached but the stimulator will not be turned on) to the left upper limb with the same placement of electrodes while undergoing PAT.
Gait Training
After PAT, participants will complete multiple 30-seconds to 4-minute bouts of walking on the treadmill or overground at speeds ranging from self-selected to fast speeds (faster than comfortable self-selected speed), with rest breaks between bouts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18-30 years
* Able-Bodied (healthy without any physical disability or neurological disorder)
Older Adults Able-Bodied Individuals (OAB)
* 45-90 years
* Able-Bodied (healthy without any physical disability or neurological disorder)
Individuals with right hemisphere stroke (40-90 years)
* \>3 months following stroke.
* Presence of Aiming SN
* Ability to walk \>10m with or without assistive devices.
* Unilateral left-sided hemiparesis with gross arm strength of ≤ grade 4/5 on the Medical Research Council Scale
* Ability to follow 3-stage commands and provide informed consent.
Exclusion Criteria
* History or evidence of orthopedic or physical disability
* History or evidence of neurological pathology
* Pregnancy (female)
* Uncontrolled hypertension
* Cardiac pacemaker or other implanted electronic system
* Presence of skin conditions preventing electrical stimulation setup
* Impaired sensation in the left upper limb.
* Bruises or cuts at the stimulation electrode placement site
* Concurrent enrollment in rehabilitation or another investigational study.
* History or evidence of orthopedic or physical disability interfering with study procedures
* History or evidence of neurological pathology or disorder
* Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) that may interfere with study procedures
* Contraindications to TMS such as metal implants, medications that can increase cortical excitability, unexplained dizziness in the past 6 months
Individuals with right hemisphere stroke (40-90 years)
* History of multiple strokes or brainstem strokes
* Cerebellar disorders
* Impaired sensation in the left upper limb.
* History of other neurological disorders
* Uncontrolled hypertension
* Cardiac pacemaker or other implanted electronic system
* Pregnancy (female)
* Presence of skin condition
* Bruises at the electrode placement site
* Concurrent enrollment in rehabilitation or another investigational study
* Severe uncontrolled medical problems (e.g., hypertension, cardiovascular disease, rheumatoid arthritis, active cancer or renal disease, epilepsy) or other medical conditions that can interfere with study procedures
* Contraindications to TMS such as metal implants in the brain, medications that will increase cortical excitability, etc.
18 Years
90 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Emory University
OTHER
Responsible Party
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Trisha Kesar
Associate Professor
Principal Investigators
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Trisha Kesar, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Fisayo Aloba, PT, DPT
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory Rehabilitation Hospital
Atlanta, Georgia, United States
Emory University Hospital (EUH)
Atlanta, Georgia, United States
Executive Park
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY00005012
Identifier Type: -
Identifier Source: org_study_id
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