Trial · NCT07895888
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
NCT07895888, Not applicable, Enrolling by invitation, University of Sao Paulo General Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke. Trials, record NCT07895888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07895888
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
- NCT number
- NCT07895888
- Status
- Enrolling by invitation
- Phases
- Not applicable
- Enrollment
- 24 participants, estimated
- Lead sponsor
- University of Sao Paulo General Hospital
- Conditions
- Spinal Cord Injuries (SCI)
- Interventions
- Single-Electrode Tonic tSCS, Multi-Electrode Spatiotemporal tSCS
- First posted
- 2026-10-26
- Last updated
- 2026-10-26
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Walking Speed Assessed by the 10-Meter Walk Test (10MWT) | Baseline (T0) and after 4 weeks of intervention (T1) | Comfortable overground walking speed will be assessed using the 10-Meter Walk Test (10MWT) and expressed in meters per second (m/s). Assistive devices and orthoses will be permitted and documented. Participants unable to complete the test due to insufficient walking ability will be assigned a value of 0 m/s for the primary analysis. This value represents inability to perform the test rather than a measured walking speed. The primary outcome will be the change in walking speed from baseline to completion of the intervention, compared between the single-electrode and multi-electrode tSCS groups. Assessment procedures will be standardized across visits. |
| Secondary | Change in Walking Ability Assessed by the Walking Index for Spinal Cord Injury II (WISCI II) | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Walking ability in participants with spinal cord injury will be assessed using the Walking Index for Spinal Cord Injury II (WISCI II). The scale ranges from 0 to 20 and classifies walking performance according to the need for physical assistance, assistive devices, and orthoses. Higher scores indicate greater walking ability. Changes in WISCI II scores will be evaluated across assessment visits. |
| Secondary | Change in Lower-Limb Motor Function Assessed by the Fugl-Meyer Assessment (FMA-LE) | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Lower-limb motor function in participants with stroke will be assessed using the lower-extremity motor subscale of the Fugl-Meyer Assessment (FMA-LE). Motor scores range from 0 to 34, with higher scores indicating better motor function. Changes in FMA-LE motor scores will be evaluated across assessment visits. |
| Secondary | Change in Lower-Limb Muscle Strength Assessed by the Medical Research Council (MRC) Scale | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Lower-limb muscle strength will be assessed using the Medical Research Council (MRC) scale. Individual muscle groups will be graded from 0 (no visible muscle contraction) to 5 (normal muscle strength). Changes in muscle strength will be evaluated in participants with spinal cord injury and stroke. Scores for the assessed muscle groups will be reported separately rather than combined into an unspecified composite score. |
| Secondary | Change in Lower-Limb Spasticity Assessed by the Modified Ashworth Scale (MAS) | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Resistance to passive movement in lower-limb muscle groups will be assessed using the Modified Ashworth Scale (MAS). The scale includes the ordinal grades 0, 1, 1+, 2, 3, and 4, with higher grades indicating greater resistance to passive movement. Changes in MAS grades will be evaluated for the assessed muscle groups without combining them into an unspecified total score- |
| Secondary | Change in Balance Assessed by the Berg Balance Scale (BBS) | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Balance performance will be evaluated using the Berg Balance Scale (BBS), which includes 14 tasks assessing static and dynamic balance. Total scores range from 0 to 56, with higher scores indicating better balance performance. Changes in total BBS scores will be evaluated across assessment visits. |
| Secondary | Change in Functional Mobility Assessed by the Timed Up and Go Test (TUG) | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Functional mobility will be assessed using the Timed Up and Go (TUG) test. The test measures the time, in seconds, required to stand from a chair, walk 3 meters, turn around, return to the chair, and sit down. Lower completion times indicate better functional mobility. Assistive devices may be used as needed and will be documented. Participants unable to complete the test will be recorded as unable to perform the assessment rather than assigned an arbitrary completion time. |
| Secondary | Change in Walking Speed at 30-Day Follow-Up Assessed by the 10MWT | Baseline (T0) and 30-day follow-up after completion of the intervention (T2) | Comfortable overground walking speed will be assessed using the 10-Meter Walk Test (10MWT) and expressed in meters per second (m/s). The outcome will be the change in walking speed from baseline to the 30-day follow-up after completion of the intervention. The same assessment procedures, documentation of assistive devices, and scoring rules defined for the primary outcome will be applied. |
| Secondary | Gait-Phase-Dependent Muscle Activation Assessed by the Phase Selectivity Index (PSI) | During the first and twentieth gait-training sessions (approximately 4 weeks apart) | Gait-phase-dependent muscle activation will be assessed using surface electromyography (EMG) recorded bilaterally from lower-limb muscles. The Phase Selectivity Index (PSI) will be calculated from the root mean square (RMS) EMG amplitude during the target gait phase relative to the non-target phase. PSI ranges from -100% to 100%, with higher values indicating greater preferential activation during the intended gait phase. Values will be evaluated for individual recorded muscles to characterize the temporal coordination of muscle activation during walking. |
| Secondary | Change in Spatial Gait Parameters Assessed by Instrumented Gait Analysis | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Spatial gait characteristics will be evaluated using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Measures include step length, stride length, and step width, all expressed in centimeters (cm). These parameters characterize the spatial dimensions of gait and will be examined as separate component measures, without calculation of a composite score. Bilateral measurements will be retained when available. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers5
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07895888
GET https://conductscience.org/api/trials/v1/NCT07895888/registered