Trial · NCT07895888
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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. |
| Secondary | Change in Walking Speed Assessed by Instrumented Gait Analysis | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Walking speed will be evaluated during instrumented gait analysis using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Speed will be expressed in centimeters per second (cm/s). This laboratory-based measure characterizes walking performance under the standardized gait assessment conditions and will be analyzed separately from the overground 10-Meter Walk Test. |
| Secondary | Change in Gait Cadence Assessed by Instrumented Gait Analysis | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Gait cadence will be evaluated using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Cadence will be expressed in steps per minute and represents the number of steps performed per unit of time. Changes in gait cadence will be used to characterize temporal aspects of walking performance. |
| Secondary | Change in Temporal Gait Phase Parameters Assessed by Instrumented Gait Analysis | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Temporal gait characteristics will be assessed using wearable inertial measurement units (IMUs) and/or three-dimensional motion capture. Measures include stance phase duration, swing phase duration, initial double-support duration, and single-support duration. Each parameter will be expressed as a percentage of the gait cycle (%). These measures characterize the distribution of time across gait phases and will be evaluated as separate components rather than combined into a composite score. |
| Secondary | Change in Resting-State EEG Spectral Power | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Resting-state cortical activity will be assessed using electroencephalography (EEG) under eyes-open and eyes-closed conditions. Power spectral density will be calculated in predefined frequency bands (delta, theta, alpha, beta, and gamma) to quantify cortical oscillatory activity. Spectral power will be assessed separately by frequency band and recording condition, with comparisons of cortical activity across assessment visits. |
| Secondary | Change in Cortical Hemodynamic Response Assessed by fNIRS | During the first and twentieth gait-training sessions (approximately 4 weeks apart) | Task-related cortical hemodynamic activity during gait training will be assessed using functional near-infrared spectroscopy (fNIRS). Changes in oxygenated hemoglobin (HbO) concentration will be estimated using a general linear model (GLM) in predefined cortical regions of interest involved in motor control. The HbO hemodynamic response will be used to assess changes in cortical activation associated with gait training. |
| Secondary | Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Concentration | Baseline (T0), after 4 weeks of intervention (T1), and 30-day follow-up (T2) | Serum brain-derived neurotrophic factor (BDNF) concentration will be quantified from peripheral blood samples using an immunoassay. Concentrations will be reported using the laboratory assay's specified units. Changes in serum BDNF concentration will be evaluated across assessment visits and compared between intervention groups as a circulating biomarker potentially associated with neuroplasticity. |
| Secondary | Change in Body-Weight Support During Treadmill Gait Training | During the 20 gait-training sessions over 4 weeks | The amount of body-weight support provided during treadmill gait training will be recorded as a percentage of the participant's body weight (%). Lower percentages indicate reduced reliance on external body-weight support. Changes in the level of support used during training will be evaluated to characterize progression in weight-bearing capacity and walking performance. |
| Secondary | Change in Treadmill Walking Speed During Gait Training | During the 20 gait-training sessions over 4 weeks | Treadmill walking speed will be recorded during supervised gait-training sessions. Speed will be expressed in kilometers per hour (km/h) and adjusted according to each participant's walking ability and tolerance. Changes in treadmill walking speed will be evaluated to characterize progression in training performance across the intervention period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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