NCT03714282

Noninvasive Spinal Stimulation in Stroke

Completed NA Results posted Last updated 17 March 2026

What this trial tests

NA trial testing Noninvasive spinal stimulation with gait training in Stroke in 8 participants. Completed in 14 May 2020.

Timeline

18 October 2018

Primary endpoint
14 May 2020

14 May 2020

Quick facts

Lead sponsor	Shirley Ryan AbilityLab
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	18 October 2018
Primary completion	14 May 2020
Estimated completion	14 May 2020
Sites	1 location across United States

Drugs / interventions tested

• Noninvasive spinal stimulation with gait training
• Conventional gait training

Conditions studied

• Stroke — all drugs for Stroke →

Sponsor

Shirley Ryan AbilityLab — full company profile →

Who can join

18 and older, any sex, with Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Step-length Symmetry Using Symmetry Index Primary · Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-\|1-Nonparetic/(Paretic side)\|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher

Pre intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	72.2	± 23.0
Conventional Gait Training	75.8	± 16.1

Post intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	92.2	± 5.4
Conventional Gait Training	76.0	± 7.0

Change in Swing-time Symmetry Primary · Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

Participants will ambulate along Gait Rite electronic walkway to evaluate baseline gait pattern at both their self-selected and safe fast gait speed. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. The gait symmetry index of spatio-temporal parameters will be calculated as (100%×(1-\|1-Nonparetic/(Paretic side)\|), which always results in a maximum value of 100%, irrespective of which limb demonstrates greater values, with improvements observed as positive values. Higher

Pre intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	57.9	± 5.6
Conventional Gait Training	57.8	± 8.4

Post intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	67.8	± 9.1
Conventional Gait Training	57.7	± 9.2

Change in 10 Meter Walk Test - Self-selected Velocity Secondary · Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).

Pre intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	0.65	± 0.19
Conventional Gait Training	0.68	± 0.21

Post intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	0.82	± 0.24
Conventional Gait Training	0.76	± 0.25

Change in 10 Meter Walk Test - Fast Velocity Secondary · Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).

Pre intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	0.81	± 0.30
Conventional Gait Training	0.91	± 0.47

Post intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	1.14	± 0.36
Conventional Gait Training	0.96	± 0.49

Change in 6 Minute Walk Test Secondary · Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patien

Pre intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	205.1	± 76.3
Conventional Gait Training	246.2	± 148.4

Post intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	266.6	± 57.4
Conventional Gait Training	272.0	± 143.7

Change in PCI During 6 Minute Walk Test Secondary · Pre and Post intervention (8 weeks of training, Post = after all training sessions completed. 3 training sessions/week x8 weeks = 24 sessions total)

Participants completed the 6MWT as heart rate was recorded throughout the testing using a Polar H7 chest belt monitor. Prior to beginning the 6MWT, average resting heart rate was recorded for two minutes while the subject was seated and quiet. Cardiac efficiency during 6MWT was measured by physiological cost index (PCI), which reflects heart rate per meter walked. Reduced PCI indicates improved cardiac efficiency.

Pre intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	1.13	± 0.37
Conventional Gait Training	1.22	± 0.50

Post intervention

Group	Value	95% CI
Noninvasive Spinal Stimulation With Gait Training	0.91	± 0.39
Conventional Gait Training	0.99	± 0.37

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Noninvasive spinal stimulation improves walking in chronic stroke survivors: a proof-of-concept case series.
   Moon Y, Yang C, Veit NC, McKenzie KA, et al · · 2024 · cited 12× · PMID 38561821 · DOI 10.1186/s12938-024-01231-1