CompletedNot Applicable

Noninvasive Spinal Stimulation in Stroke

United States8 participantsStarted 2018-10-18

Plain-language summary

This is a randomized control trial that will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Healthy Control Group Inclusion Criteria: * Age 18 or older * Able and willing to give written consent and comply with study procedures Healthy Control Group Exclusion Criteria: * No history of cerebrovascular accidents or neurological degenerative pathologies (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.) * Pregnant or nursing * Skin allergies or irritation; open wounds * Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD) Stroke Group Inclusion Criteria: * Participants are 18 years of age or older * Participants are at least 4 weeks post stroke * Participants with hemiplegia secondary to a single stroke * Functional Ambulation Category of 2 or greater - Patient needs continuous or intermittent support of one person to help with balance and coordination. * Participants are able to provide informed consent * Participants are not currently receiving regular physical therapy services Stroke Group Exclusion Criteria: * Individuals less than18 years of age * Individuals less than 4 weeks post stroke * Individuals with ataxia * Individuals with multiple stroke history * Currently taking a Selective Serotonin Reuptake Inhibitor (SSRI) or Tricyclic antidepressant (TCA) * Botox injection in lower extremity within the last 4 months * Modified Ashworth score of 3 or greater in lower extremity * Pregnancy or nursing * Pacemaker or anti-spasticity implantable pumps * Active…

What they're measuring

Change in Step-length Symmetry Using Symmetry Index

Timeframe: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

Change in Swing-time Symmetry

Timeframe: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

Trial details

NCT IDNCT03714282

SponsorShirley Ryan AbilityLab

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-14

Results submitted2021-11-08

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Step-length Symmetry Using Symmetry Index

Timeframe: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

Change in Swing-time Symmetry

Timeframe: Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)