Adults 18 to 65, any sex, with Spinal Cord Injuries. 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.
10 Meter Walk Test (Walk Speed)Primary· D1, D5
Walking speed was the primary outcome measure for walking function, as speed has been the standard measure used in the literature and allowed us to assess outcomes relative to other published studies. Walking speed was determined using the 10-Meter Walk Test. Participants completed 3 walk trials at each time point, separated by 2 minutes of seated rest. The average walking speed of 3 walks was calculated and used in the analyses. Data reported were obtained at baseline at Day 1 (D1) and at follow-up on Day 5 (D5), 24-hours post-intervention.
Gait quality was quantified by spatiotemporal gait characteristics (cadence \[strides/min\], stride length \[cm\] and step length \[cm\] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Cadence for each walk trial was computed using the GAITRite system, and the average cadence across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Gait quality was quantified by spatiotemporal gait characteristics (cadence \[strides/min\], stride length \[cm\] and step length \[cm\] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average stride length of the weaker limb for each walk trial was computed from data obtained from the GAITRite system, and the average stride length across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on D
Gait quality was quantified by spatiotemporal gait characteristics (cadence \[strides/min\], stride length \[cm\] and step length \[cm\] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average stride length of the stronger limb for each walk trial was computed from data obtained from the GAITRite system, and the average stride length across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on
Step length \[cm\] of the weaker and stronger limbs were collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average step length of each lower limb for each walk trial was computed from data obtained from the GAITRite system. Lower limbs were classified as stronger or weaker according to manual muscle test scores collected at baseline (D1). The average step length for the stronger and weaker limbs was used to calculate the step symmetry index (SI) using the following formula: SI = ((SLs - SLw)/0
Ankle dorsiflexion (tibialis anterior) strength was measured with the subject seated and with the test foot strapped to a handheld dynamometer. An ankle dorsiflexion test was selected based on evidence indicating that the tibialis anterior is under the greatest corticospinal control. Maximum dorsiflexion force was calculated based on the highest force measured over three attempts. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Day 1 (D1)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
57.7
34.4 – 72.8
Motor Skill Training + tDCS (MST+tDCS)
68.3
57.3 – 82.0
Day 5 (D5)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
49.3
31.8 – 64.5
Motor Skill Training + tDCS (MST+tDCS)
72.9
57.6 – 92.9
Berg Balance ScaleSecondary· D1, D5
Balance was measured using the Berg Balance Scale (BBS), which has been found to be valid for use in persons with SCI. The BBS total score was calculated for each participant at each time point, and the median score for each group was calculated. The total range of scores for the BBS equals 0-56, with higher scores from baseline indicating greater balance performance and lower scores from baseline indicating worsened balance performance. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Day 1 (D1)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
38.0
25.5 – 50.8
Motor Skill Training + tDCS (MST+tDCS)
46.0
39.0 – 51.0
Day 5 (D5)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
41.5
29.3 – 46.8
Motor Skill Training + tDCS (MST+tDCS)
49.0
39.5 – 54.0
Falls Efficacy Scale-International Version (FES-I)Secondary· D1, D5
The fear of falling may be a major concern for persons with mobility impairments and may limit one's confidence or ability to perform activities of daily living. Fear of falling may also limit an individual's performance of specific overground motor tasks irrespective of functional ability to perform that task. Therefore, the fear of falling was an important factor to consider relative to the mobility interventions employed in the present study. The FES-I total score was calculated for each participant at each time point, and the median for each group was recorded. The total range of scores po
Day 1 (D1)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
34.0
29.3 – 40.0
Motor Skill Training + tDCS (MST+tDCS)
33.0
30.5 – 43.5
Day 5 (D5)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
33.5
28.5 – 36.8
Motor Skill Training + tDCS (MST+tDCS)
28.0
26.0 – 43.5
Spinal Cord Assessment Tool for Spastic ReflexesSecondary· D1, D5
The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) was used to assess the impact of motor skill training + sham stimulation and motor training + tDCS on spasticity. SCATS is well correlated with electrophysiological measures of spasticity and is better correlated with self-reported measures of spasm frequency than the Ashworth test. Total SCATS scores for each limb were summed and median values were obtained for each group. The total range of scores possible for the SCATS is 0-18, with a total score of 0 indicating no lower limb spasticity and higher total scores indicating greater s
Day 1 (D1)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
4.0
2.0 – 7.5
Motor Skill Training + tDCS (MST+tDCS)
4.0
2.0 – 6.5
Day 5 (D5)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
6.0
3.5 – 7.0
Motor Skill Training + tDCS (MST+tDCS)
4.0
1.0 – 7.0
Modified 5-Times Sit-to-StandSecondary· D1, D5
The modified 5-times sit-to-stand test was used as a measure of functional lower extremity strength. In this test, the participant was seated on a mat table with height adjusted to 80% of lower extremity length. The time required to complete 5 repetitions of standing up and sitting down (without using the upper extremities for assistance) was recorded. The average time to complete the test was calculated at each time point for each group. Lower sit-to-stand times indicate greater functional lower extremity strength. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up
Knee extensor (quadriceps) strength was measured with participants seated, with the test leg strapped to a handheld dynamometer. Prior studies have shown that a single session of tDCS improves quadriceps strength in persons with stroke. Maximum knee extensor force was analyzed based on the maximum force produced over three attempts. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Day 1 (D1)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
86.7
63.6 – 114.3
Motor Skill Training + tDCS (MST+tDCS)
92.1
78.5 – 118.1
Day 5 (D5)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
84.4
52.5 – 90.4
Motor Skill Training + tDCS (MST+tDCS)
103.5
85.4 – 131.9
2 Minute Walk TestSecondary· D1, D5
Functional walking capacity was measured based on 2-minute walk test distance. The use of the 2-minute rather than the 6-minute walk test allowed us to include individuals whose impairments result in inability to walk for 6 minutes. Total distance walked in 2-minutes was recorded for each participant at each time point, and the average distance was calculated for each group. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Day 1 (D1)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
83.1
± 49.4
Motor Skill Training + tDCS (MST+tDCS)
77.1
± 55.3
Day 5 (D5)
Group
Value
95% CI
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
93.7
± 50.3
Motor Skill Training + tDCS (MST+tDCS)
86.7
± 50.7
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
For many people with spinal cord injury (SCI), the goal of walking is a high priority. There are many approaches available to restore walking function after SCI; however, these approaches often involve extensive rehabilitation training and access to facilities, qualified staff, and advanced technology that make practicing walking at home difficult. For this reason, developing training approaches that could be easily performed in the home would be of great value. In addition, non-invasive brain stimulation has the potential to increase the effectiveness of communication between the brain and spinal cord. Combining motor skill training with brain stimulation may further enhance the restoration of function in persons with SCI. Based on these findings, the primary aim of this proof-of-concept study is to inform future intervention development. To meet this aim, we will determine if moderate-intensity, motor skill training can improve walking-related outcomes among persons with SCI and to determine if the addition of non-invasive brain stimulation will result in greater improvements in function compared to training alone.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shepherd Center, Atlanta GA
Last refreshed: 12 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03237234.