No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
115 (estimated)
Sponsor
Shirley Ryan AbilityLab · Other
Who this trial is looking for
This trial is looking for individuals with hemiplegia from a stroke to see if a non-invasive spinal cord stimulation treatment can improve walking and balance. Participants will need to be at least 18 years old and have had their stroke at least 6 months ago.
Are You a Good Fit for This Trial?
Rules you outMultiple strokesAtaxiaUnhealed bone fracturesActive cancerSevere mental health issues
You may be able to join if
I am 18 years or older
I can give written consent and follow study procedures
I am at least 6 months post-stroke
I have hemiplegia from a single stroke
I need some support to help with walking
I am not currently in regular physical therapy
I have my doctor's approval to participate
You may not be able to join if
I have ataxia
I have had multiple strokes
I received Botox in my legs in the last 4 months
I am pregnant or nursing
I have active pressure sores
I have a current urinary tract infection
I have severe issues with my mental health or substance abuse
I have active cancer or cancer that was treated less than 5 years ago
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study has two interventional components, the first is a cross-over design and the second is a randomized control trial. Both will evaluate the effectiveness of transcutaneous (non-invasive) spinal cord stimulation on gait and balance function for individuals with hemiplegia due to stroke.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria
* Age 18 years or older
* Able and willing to give written consent and comply with study procedures
* At least 6 months' post-stroke
* Hemiplegia secondary to a single stroke
* Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support…
Inclusion Criteria
* Age 18 years or older
* Able and willing to give written consent and comply with study procedures
* At least 6 months' post-stroke
* Hemiplegia secondary to a single stroke
* Functional Ambulation Category of 2 or greater - i.e., subject needs continuous or intermittent support of one person to help with balance and coordination.
* Not currently receiving regular physical therapy services
* Physician approval to participate
Exclusion Criteria
* Ataxia
* Multiple stroke history
* Botox injection in lower extremity within the last 4 months
* Modified Ashworth score of 3 or greater in lower extremity
* Pregnant or nursing
* Using a powered, implanted cardiac device for monitoring or support of heart function (i.e. pacemaker, defibrillator, or LVAD) or anti-spasticity implantable pumps
* Active pressure sores
* Unhealed bone fractures
* Peripheral neuropathies
* Painful musculoskeletal dysfunction due to active injuries or infections
* Severe contractures in the lower extremities
* Medical illness limiting the ability to walk
* Active urinary tract infection
* Clinically significant depression, psychiatric disorders, or ongoing drug abuse
* Active cancer or cancer in remission less than 5 years
* Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the lower extremity.
* Traumatic brain injury or other neurological conditions that would impact the study.
TMS-Specific Exclusion Criteria: TMS will be utilized for both Aims. The sub-set of participants who meet these criteria will participate in this component of the studies.
* Medicated with agents known to increase (e.g., amphetamines) or decrease motor system excitability (e.g., lorazepam)
* Implanted cardiac pacemaker
* Metal implants in the head or face
* Suffers unexplained, recurring headaches
* Had a seizure in the past unrelated to the stroke event, or has epilepsy
* Skull abnormalities or fractures
* A concussion within the last 6 months
* Unstable cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension, uncontrolled diabetes, or chronic emphysema)
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