Concomitant sensory stimulation during therapy to enhance hand functional recovery post stroke.

Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE

Original Publication: [London] : BioMed Central, 2006-

Activities of Daily Living* ; Stroke Rehabilitation*; Hand ; Humans ; Quality of Life ; Recovery of Function ; Treatment Outcome ; Upper Extremity

Background: Post-stroke hand impairment is prevalent and persistent even after a full course of rehabilitation. Hand diminishes stroke survivors' abilities for activities of daily living and independence. One way to improve treatment efficacy is to augment therapy with peripheral sensory stimulation. Recently, a novel sensory stimulation, TheraBracelet, has been developed in which imperceptible vibration is applied during task practice through a wrist-worn device. The objective of this trial is to determine if combining TheraBracelet with hand task practice is superior to hand task practice alone.
Methods: A double-blind randomized controlled trial will be used. Chronic stroke survivors will undergo a standardized hand task practice therapy program (3 days/week for 6 weeks) while wearing a device on the paretic wrist. The device will deliver TheraBracelet vibration for the treatment group and no vibration for the control group. The primary outcome is hand function measured by the Wolf Motor Function Test. Other outcomes include the Box and Block Test, Action Research Arm Test, upper extremity use in daily living, biomechanical measure of the sensorimotor grip control, and EEG-based neural communication.
Discussion: This research will determine clinical utility of TheraBracelet to guide future translation. The TheraBracelet stimulation is delivered via a wrist-worn device, does not interfere with hand motion, and can be easily integrated into clinical practice. Enhancing hand function should substantially increase stroke survivors' independence and quality of life and reduce caregiver burden.
Trial Registration: NCT04569123 . Registered on September 29, 2020.
(© 2022. The Author(s).)

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P20 GM109040 United States GM NIGMS NIH HHS; R01 HD094731 United States HD NICHD NIH HHS; R01HD094731-01A1 National Institute of Child Health and Human Development

Keywords: EEG; Hand; Hand function; Neurologic rehabilitation; Occupational therapy; Paralysis; Physical rehabilitation; Physical stimulation; Randomized controlled trial; Stroke; Stroke rehabilitation; Subliminal stimulation; Upper extremity; Upper limb paresis

ClinicalTrials.gov NCT04569123

Date Created: 20220406 Date Completed: 20220407 Latest Revision: 20220506

20250114

PMC8981199

10.1186/s13063-022-06241-9

35382902