Spatial-Motor Stroke-Rehab Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06053320
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Prism adaptation therapy (PAT) + Electrical stimulation (E-stim) — DEVICE
    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 — DEVICE
    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 — OTHER
    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.

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 individuals
    18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
  • Active Comparator: Old Able-Bodied individuals
    45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).
  • Experimental: Stroke with Spatial Neglect (SN) individuals
    40-90 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

Locations (3)

FacilityCityStateZIPSite coordinators
Emory Rehabilitation HospitalAtlantaGeorgia30322
Fisayo Aloba, PT, DPT
Emory University Hospital (EUH)AtlantaGeorgia30322
Fisayo Aloba, PT, DPT
Executive ParkAtlantaGeorgia30329
Fisayo Aloba, PT, DPT

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