Spatial-Motor Stroke-Rehab Study
Novel Spatial-Motor Approaches to Improve Spatial Neglect and Walking Deficits Post-Stroke
Emory University
65 participants
Apr 11, 2023
INTERVENTIONAL
Summary
The purpose of this study is to understand how prism adaptation training with and without electrical stimulation changes visuospatial behavior, motor system neurophysiology, and walking dysfunction.
Eligibility
Inclusion Criteria12
- Young Adults Able Bodied (YAB) Individuals
- -30 years
- Able-Bodied (healthy without any physical disability or neurological disorder)
- Older Adults Able-Bodied Individuals (OAB)
- -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 Criteria27
- Young Adults Able Bodied (YAB) Individuals and Older Adults Able-Bodied Individuals (OAB)
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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).
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.
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.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06053320