N/A
Completed N=25
Enhancing Corticospinal Activation for Improved Walking Function
Spinal Cord Injuries
Source: ClinicalTrials.gov NCT03237234 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcomePrimary: 10 Meter Walk Test (Walk Speed) — 0.72; 0.64; 0.85; 0.78 m/sec
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 10 Meter Walk Test (Walk Speed) |
0.72; 0.64; 0.85; 0.78 | — |
| SECONDARY Spatiotemporal Gait Characteristic (Cadence) |
73.9; 70.7; 81.5; 82.1 | — |
| SECONDARY Spatiotemporal Gait Characteristic (Stride Length - Weaker Limb) |
106.6; 95.0; 114.7; 104.5 | — |
| SECONDARY Spatiotemporal Gait Characteristic (Stride Length - Stronger Limb) |
106.7; 94.4; 114.5; 103.7 | — |
| SECONDARY Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index) |
14.6; 12.3; 16.2; 13.6 | — |
| SECONDARY Maximal Isometric Dorsiflexor Strength |
57.7; 68.3; 49.3; 72.9 | — |
| SECONDARY Berg Balance Scale |
38.0; 46.0; 41.5; 49.0 | — |
| SECONDARY Falls Efficacy Scale-International Version (FES-I) |
34.0; 33.0; 33.5; 28.0 | — |
| SECONDARY Spinal Cord Assessment Tool for Spastic Reflexes |
4.0; 4.0; 6.0; 4.0 | — |
| SECONDARY Modified 5-Times Sit-to-Stand |
13.7; 21.9; 14.9; 19.6 | — |
| SECONDARY Maximal Isometric Quadriceps Strength |
86.7; 92.1; 84.4; 103.5 | — |
| SECONDARY 2 Minute Walk Test |
83.1; 77.1; 93.7; 86.7 | — |
Eligibility Criteria
Inclusion Criteria
- Have a spinal cord injury (neurological level C3-T10);
- Chronic SCI (12 months or greater);
- Neurological impairment classification C or D;
- Able to stand for at least 5 minutes (with or without an assistive device);
- Able to move each leg independently for at least 3 steps;
- Able to rise from sit to stand with moderate assistance from one person;
- Ability and willingness to consent and authorize use of personal health information.
Exclusion Criteria
- Progressive spinal lesions including degenerative, or progressive vascular disorders of the spine and/or spinal cord;
- Injuries below the neurological spinal level of T10;
- History of cardiovascular irregularities;
- Altered cognitive status;
- Presence of orthopedic conditions that would adversely affect participation in exercise;
- Implanted metallic objects in the head;
- History of seizures;
- Inability and unwillingness to consent and authorize use of personal health information.
Data sourced from ClinicalTrials.gov (NCT03237234). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.