Exploratory Phase - Optimization of Gait Training and Spinal Stimulation for Stroke

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Shirley Ryan AbilityLab, Chicago, ILStrokeExploratory Phase - Optimization of Gait Training and Spinal Stimulation - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

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

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: Device
Aim 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: Device
Stimulation Only
Device
ActiveComparator Group · 1 Intervention: Noninvasive spinal stimulation · Intervention Types: Device
Sham Only
Other
ShamComparator Group · 1 Intervention: Sham · Intervention Types: Other
Aim 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?
Illinois100.0%
How old are they?
65+100.0%
What site did they apply to?
Shirley Ryan AbilityLab100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

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
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.