N/A
N=44
Transcranial Direct Current Stimulation for Post-stroke Gait Rehab
Stroke · Gait Impairment
Bottom Line
View on ClinicalTrials.gov: NCT03666533 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Gait Speed From Baseline (Meters/Second) — 0.16; 0.12 meters/second
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active transcranial Direct Current Stimulation (Other); Sham transcranial Direct Current Stimulation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gait Speed From Baseline (Meters/Second) |
0.16; 0.12 | — |
| SECONDARY Change From Baseline to Post Treatment on Timed up and go (Seconds) |
-6.93; -5.7 | — |
| SECONDARY Change From Baseline to Post Treatment in Functional Gait Assessment (Points) |
2.79; 2.38 | — |
| SECONDARY Change From Baseline to Post Treatment on Fugl Meyer Lower Limb |
2.26; 2.62 | — |
| SECONDARY Change From Baseline to Post Treatment on Gait Assessment and Intervention Tool |
-2.42; -2.86 | — |
| SECONDARY Change in Asymmetry of Tibialis Anterior Muscle Motor Evoked Potentials From Baseline |
9; 8 | — |
Summary
Stroke affects upwards of 800,000 Americans every year and has an enormous impact on the well-being of the American Veteran population with 6,000 new stroke admissions every year. Many of these stroke survivors are living with walking disabilities. Gait problems result in inability to function independently, high risk of falls and poor quality of life. Unfortunately, current gait rehabilitation treatments are limited and many stroke survivors do not achieve full recovery. Therefore, it is critical to develop new approaches to enhance gait rehabilitation methods. The investigators propose to evaluate a brain stimulation treatment called transcranial Direct Current Stimulation (tDCS) that can be added to physical therapy. tDCS has been applied for arm rehabilitation after stroke with positive results, but gait-related investigations are lacking. The investigators will test whether simultaneous tDCS and gait training produces greater improvement in walking abilities than gait training alone. Adjunct tDCS therapy may improve outcomes, and reduce cost of both rehabilitation and post-stroke care.
Eligibility Criteria
Inclusion Criteria
- Medically and psychologically stable and at least 6 months after first ever unilateral stroke
- Cognition sufficiently intact to give valid informed consent to participate
- FMLE score >15; and ability to actively dorsiflex the paretic ankle in synergy (FMLE item II Flexor synergy-ankle dorsiflexion score 1).
- Sufficient endurance to participate in the study
Exclusion Criteria
- Activity tolerance is insufficient to complete treadmill training
- Inability to produce a trace contraction of ankle dorsiflexors in synergy
- Normal ankle dorsiflexion/knee flexion on FMLE standing items (FMLE item IV score=4)
- Stroke affecting both sides
- Contraindications for rTMS according to the most recent TMS-use guidelines
- Contraindications for MRI
- Inability to understand English
Data sourced from ClinicalTrials.gov (NCT03666533). 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.