Transformation of Paralysis to Stepping
NCT04105114, Early phase 1, Active not recruiting, University of Louisville
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Transformation of Paralysis to Stepping | ClinicalTrials.gov |
| NCT number | NCT04105114 | ClinicalTrials.gov |
| Status | Active not recruiting | ClinicalTrials.gov |
| Phases | Early phase 1 | ClinicalTrials.gov |
| Enrollment | 15 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Louisville | ClinicalTrials.gov |
| Conditions | Spinal Cord Injuries | ClinicalTrials.gov |
| Interventions | Buspirone, Non-invasive Spinal Cord Stimulation, Overground stepping, Gravity Neutral Device, Body Weight Supported Treadmill Training, Rolling Walker | ClinicalTrials.gov |
| First posted | 2019-09-26 | ClinicalTrials.gov |
| Last updated | 2026-03-13 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Lower Extremity Electromyography, change over time | Before and after each study phase, 1 year per group. | Assessment of muscle activity, measured by electromyography, while the leg is suspended in a gravity neutral position. | ClinicalTrials.gov |
| Primary | Lower Extremity Kinematics, change over time | Before and after each study phase, 1 year per group. | Assessment of low extremity 3D position, measured by motion analysis system, while the leg is suspended in a gravity neutral position. | ClinicalTrials.gov |
| Primary | Treadmill Electromyography Assessment, change over time | Before and after each study phase, 1 year per group. | Muscle activity, measured by electromyography, will be recorded during weight supported stepping on a treadmill. | ClinicalTrials.gov |
| Primary | Spinal Pathway Electrophysiology, change over time | Before and after each study phase, 1 year per group. | Evoked potentials in the lower extremities will recorded in response to nerve or spinal stimulation. | ClinicalTrials.gov |
| Primary | Voluntary Lower Extremity Angles, change over time | Before and after each study phase, 1 year per group. | Assessments of knee, ankle, and toe movements will be performed by measuring angles produced during flexion and extension. The same units of measure will be used for each part of the leg. | ClinicalTrials.gov |
| Primary | Voluntary Lower Extremity Forces, change over time | Before and after each study phase, 1 year per group. | Assessments of knee, ankle, and toe forces during movements will be performed by measuring forces produced during flexion and extension. The same units of measure will be used for each part of the leg. | ClinicalTrials.gov |
| Primary | Body Temperature, change over time | Before and after each study phase, 1 year per group. | We will measure body temperature using standard methods to assess values at rest and during exercise. | ClinicalTrials.gov |
| Primary | Blood Pressure, change over time | Before and after each study phase, 1 year per group. | We will measure blood pressure (systolic and diastolic) using standard methods to assess values at rest and during exercise. | ClinicalTrials.gov |
| Primary | Heart Rate, change over time | Before and after each study phase, 1 year per group. | We will measure the heart rate using standard electrocardiography to assess values at rest and during exercise. | ClinicalTrials.gov |
| Primary | Respiration Rate, change over time | Before and after each study phase, 1 year per group. | We will measure respiratory rate using standard methods to assess values at rest and during exercise. | ClinicalTrials.gov |
| Primary | Dual-energy X-ray absorptiometry, change over time | Before and after each study phase, 1 year per group. | We will use dual-energy X-ray absorptiometry to measure bone and soft tissue density. | ClinicalTrials.gov |
| Primary | Acoustic Gastro-Intestinal Surveillance, change over time | Before and after each study phase, 1 year per group. | We will use non-invasive sensors placed on the abdomen to detect signals related to the digestive state. | ClinicalTrials.gov |
| Primary | Bladder capacity, change over time | Before and after each study phase, 1 year per group. | We will use a standard technique to measure bladder volume change during voiding. | ClinicalTrials.gov |
| Primary | Urodynamics, change over time | Before and after each study phase, 1 year per group. | We will use a standard technique to measure the abdominal pressure change during voiding. | ClinicalTrials.gov |
| Primary | Cognitive interference, change over time | Before and after each study phase, 1 year per group. | A cognitive assessment using Stroop test will be administered to assess cognitive function during stress. | ClinicalTrials.gov |
| Primary | Assessment of verbal fluency, change over time | Before and after each study phase, 1 year per group. | Controlled Oral Word Association Test (COWAT) will be administered to assess verbal fluency that measures ability of spontaneous production of words. | ClinicalTrials.gov |
| Secondary | International Standards of Neurological Classification of Spinal Cord Injury, change over time | Before and after each study phase, 1 year per group. | This standard clinical assessment assess the level and severity of a spinal cord injury. The neurological level of injury is rated from A-E. "A" is a motor and sensory complete injury. "E" is completely normal at each spinal segment. Sensory function is rated as 0-2, or Not Testable. Motor function is rated as 0-5 or Not Testable. | ClinicalTrials.gov |
| Secondary | Spinal Cord Injury Functional Ambulation Inventory, change over time | Before and after each study phase, 1 year per group. | This 3-part scale measures gait parameters, use of assistive devices, and distances traveled during walking. The gait parameters are scored on a 20-point scale, the assistive device use on a 14-point scale, and the walking distance on a 5-point scale. | ClinicalTrials.gov |
| Secondary | Spinal Cord Independence Measure III, change over time | Before and after each study phase, 1 year per group. | This 3-part scale is scored out of 100 points possible. The first part (self-care) is scored out of 20. The second part (respiration and sphincter management) is scored out of 40. And the last part (mobility) is scored out of 40. | ClinicalTrials.gov |
| Secondary | Walking Index for Spinal Cord Injury-II, change over time | Before and after each study phase, 1 year per group. | This is a 20-point scale used to assess the amount of physical assistance needed during walking. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01NS102920 | Transformation of Paraplegic Paralysis to Overground Stepping in Humans | OVECHKIN, ALEXANDER VLADIMIROVICH | UNIVERSITY OF LOUISVILLE | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2019 to 2023 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)