The Effect of SRS on Hemiplegia in Stroke Survivors

NCT06357247 | Suspended

• 1 other identifier: HM20027093
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors.

Conditions

Stroke

Keywords

SRS- stochastic resonance stimulation; SR- stochastic resonance

Outcome Measures

Primary Outcomes (1)

• Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients

  To determine the feasibility of wearing a stochastic resonance device at home in chronic stroke patients. This is administered through a participant questionnaire. Some questions are point-based (scale of 1-5), and some are open-ended questions. A good score is considered to be a higher signal-to-noise ratio, indicating better performance and detection capabilities

  Six months post stroke

Secondary Outcomes (1)

• Optimal level of stochastic resonance vibration

  Six months post stroke

Study Arms (1)

Feasibility Arm

EXPERIMENTAL

Wearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke).

Device: Sensory Threshold; Behavioral: Nine Hole Peg Test; Behavioral: Semmes Weinstein Monofilament Assessment

Interventions

Nine Hole Peg Test BEHAVIORAL

The Nine-Hole Peg Test (NHPT) is considered as a gold standard measure of manual dexterity and most frequently used in MS research and clinical practice. The score for the 9-HPT is an average of the four trials. The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged. On average, healthy male adults complete the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand.

Feasibility Arm

Sensory Threshold DEVICE

Using a light, vibrotactile noise device on the participant's affected wrist. The actuator will be positioned on both the dorsal and volar sides of the wrist. Each participant's sensory threshold will be measured using the method of ascending and descending limits

Feasibility Arm

Semmes Weinstein Monofilament Assessment BEHAVIORAL

A non-invasive, low-cost, simple, and accurate handheld calibrated nylon thread that buckles once it has delivered a force of 10 g. It provides a standardized measure of a patient's ability to sense a point of pressure. The filaments are classified from grade 1 to 5 according to their thickness: 1.65-2.83 = grade 5, 3.22-3.61 = grade 4, 3.84-4.31 = grade 3, 4.56-6.45 = grade 2, and 6.65 = grade 1.

Feasibility Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stroke survivors over the age of 18
• At least six months post stroke
• Ability to provide verbal informed consent and written informed consent
• Score of at least 56 on the Fugl meyer assessment total motor scores
• Able to detect at least 6.65 (300 grams) on the Semmes Weinstein monofilament on both the pads of the thumb and index finger
• Able to complete the nine hole peg test
• Able to reliably express pain, discomfort, or fear
• Speak english

You may not qualify if:

• History of upper extremity orthopedic conditions, such as arthritis, surgery, etc.
• Aphasia caused by stroke
• Does not have AROM
• Currently have muscle contractures in upper extremity
• Participating in other research studies
• Patients with electrically operated implanted device (e.g. cardiac pacemaker/defibrillator, drug delivery pump, and neurostimulator)
• History of SMI (e.g. schizophrenia, schizoaffective disorder)
• History of neurodegenerative disability (e.g. Multiple Sclerosis, Parkinson's Disease)
• Have received botulinum injections in the paretic limb within the past three months

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 232398, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Virginia Chu

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: April 10, 2024
• Study Start: March 4, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)