Exploratory Phase - Optimization of Gait Training and Spinal Stimulation for Stroke
Phase-Based Progress Estimates
Effectiveness
Safety
Shirley Ryan AbilityLab, Chicago, ILStrokeExploratory Phase - Optimization of Gait Training and Spinal Stimulation - Other
Study Summary
This trial will study if a non-invasive spinal cord stimulator can help improve gait and balance for people with hemiplegia caused by stroke.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: Aim 1: Baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. Aim 2: Baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Month 3
Change in 10 Meter Walk Test
Change in Gait Symmetry
Month 3
Change in 6 Minute Walk Test
Trial Safety
Safety Progress
Trial Design
10 Treatment Groups
Gait Training + Sham Stimulation
1 of 10
Stimulation Only
1 of 10
Aim 1: Stimulation Only
1 of 10
Aim 1: Gait Training + Sham Stimulation
1 of 10
Aim 2: Gait Training + Sham Stimulation
1 of 10
Gait Training + Stimulation
1 of 10
Aim 1: Gait Training + Stimulation
1 of 10
Aim 2: Gait Training + Stimulation
1 of 10
Sham Only
1 of 10
Aim 1: Sham Only
1 of 10
Active Control
Experimental Treatment
Non-Treatment Group
115 Total Participants · 10 Treatment Groups
Primary Treatment: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation · Has Placebo Group · N/A
Gait Training + Stimulation
Device
Experimental Group · 1 Intervention: Noninvasive spinal stimulation with gait training · Intervention Types: DeviceAim 1: Gait Training + StimulationExperimental Group · 2 Interventions: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation, Noninvasive spinal stimulation with gait training · Intervention Types: Other, Device
Aim 2: Gait Training + StimulationExperimental Group · 2 Interventions: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation, Noninvasive spinal stimulation with gait training · Intervention Types: Other, Device
Gait Training + Sham Stimulation
Device
ActiveComparator Group · 1 Intervention: Conventional gait training · Intervention Types: DeviceStimulation Only
Device
ActiveComparator Group · 1 Intervention: Noninvasive spinal stimulation · Intervention Types: DeviceSham Only
Other
ShamComparator Group · 1 Intervention: Sham · Intervention Types: OtherAim 1: Stimulation OnlyActiveComparator Group · 2 Interventions: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation, Noninvasive spinal stimulation · Intervention Types: Other, Device
Aim 1: Gait Training + Sham StimulationActiveComparator Group · 2 Interventions: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation, Conventional gait training · Intervention Types: Other, Device
Aim 1: Sham OnlyShamComparator Group · 2 Interventions: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation, Sham · Intervention Types: Other, Other
Aim 2: Gait Training + Sham StimulationActiveComparator Group · 2 Interventions: Exploratory Phase - Optimization of Gait Training and Spinal Stimulation, Conventional gait training · Intervention Types: Other, Device
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: aim 1: baseline pre-intervention immediately post intervention for interventions 1, 2, 3 and 4. aim 2: baseline pre-intervention, 4 weeks into the intervention, immediately post intervention and 3 months post intervention for intervention 1 and 2.
Who is running the clinical trial?
University of California, Los AngelesOTHER
1,420 Previous Clinical Trials
6,748,731 Total Patients Enrolled
30 Trials studying Stroke
3,287 Patients Enrolled for Stroke
Shirley Ryan AbilityLabLead Sponsor
174 Previous Clinical Trials
13,601 Total Patients Enrolled
65 Trials studying Stroke
6,049 Patients Enrolled for Stroke
Arun Jayaraman, PT, PhDPrincipal InvestigatorShirley Ryan AbilityLab
21 Previous Clinical Trials
2,702 Total Patients Enrolled
9 Trials studying Stroke
1,452 Patients Enrolled for Stroke
Eligibility Criteria
Age 18+ · All Participants · 15 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have frequent headaches with no clear cause.
You are taking medications that affect your body's ability to move or be active, such as amphetamines or lorazepam.
You need someone to help you keep your balance and coordination while walking.
You have a device called a pacemaker implanted in your heart.
You have a history of seizures not caused by the stroke, or you have epilepsy.
You have experienced a stroke at least 6 months ago.
You have paralysis on one side of your body from a single stroke.
You have metal implants in your head or face.
You have an abnormality or fracture in your skull.
You had a head injury called a concussion in the past 6 months.
Who else is applying?
What state do they live in?
| Illinois | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| Shirley Ryan AbilityLab | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Frequently Asked Questions
Are there any open slots for new participants in this research?
"Yes, this is an active trial that has been posted since March 1st, 2022 and was edited recently on September 9th. They are looking for 115 individuals to participate at a single site." - Anonymous Online Contributor
Unverified Answer