Spatial-Motor Stroke-Rehab Study
Part of paid clinical trials in Atlanta, Georgia.
- Sponsor
- Emory University
- Study ID
- NCT06053320
- Status
- Recruiting
Conditions
- Spatial Neglect
- Stroke
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 90 Years
- Healthy Volunteers
- Accepted
Interventions
- Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) — DEVICEPAT 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 — DEVICEParticipants 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 — OTHERAfter 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.
Study Details
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.
Key Dates
- Start date
- Apr 11, 2023
- Status verified
- May 2026
- Primary completion
- Sep 30, 2026
- Completion
- Sep 30, 2026
Study Design
- Enrollment
- 65 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- OTHER
Arms
- Active Comparator: Young Able-Bodied individuals18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
- Active Comparator: Old Able-Bodied individuals45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
- Experimental: Stroke with Spatial Neglect (SN) individuals40-90 years individuals with more than 3 months following right hemisphere stroke.
Primary Outcome Measure
Change in visuospatial pointing behavior [ Time Frame: Pre-training and immediately after training session ]
Central Contacts
- Fisayo Aloba, PT, DPT404-712-5803
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emory Rehabilitation Hospital | Atlanta | Georgia | 30322 | Fisayo Aloba, PT, DPT |
| Emory University Hospital (EUH) | Atlanta | Georgia | 30322 | Fisayo Aloba, PT, DPT |
| Executive Park | Atlanta | Georgia | 30329 | Fisayo Aloba, PT, DPT |
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