Using Transcranial Direct Current Stimulation to Jump Start Gait Training in Chronic Stroke Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- University of Arkansas
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to determine if transcranial direct current stimulation (tDCS)applied over the lower extremity motor cortex in conjunction with assisted gait training is effective for improving gait in patients with chronic stroke.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Stroke survivors \> 3 months from most recent unilateral, stroke based on clinically or experimentally obtained MRI brain scans and behavioral evidence of stroke (e.g., risk factors, hemiplegia, unilateral sensory impairment, or localized higher cortical dysfunction) by report or in the medical record.
- •Age: \>21 years of age.
- •Complete NIH Stroke Scale.
- •Sufficient endurance, motor ability and balance to ambulate at least 10 meters continuously with moderate or less assistance.
- •Demonstrate gait impairment during ambulation such that gait instability or inefficient gait patterns \[gait pattern manifesting "dragging" or "catching" of the affected toes during swing phase of gait, or use of compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb or hiking the affected hip to clear the toes\] are exhibited.
- •Pass the Transcranial Magnetic Stimulation (TMS) Adult Safety Screen (TASS) except for items related specifically to stroke and the treatment for stroke.
Exclusion Criteria
- •Edema, skin breakdown, absent sensation of the affected lower limb which interferes with the peroneal nerve stimulator.
- •History of potentially fatal cardiac arrhythmias, such as ventricular tachycardia, supraventricular tachycardia, and rapid ventricular response atrial fibrillation with hemodynamic instability.
- •Demand pacemakers or any other implanted electronic systems.
- •Pregnant women, uncontrolled seizure disorder, Parkinson's Disease, Spinal cord injury, Traumatic brain injury with evidence of motor weakness, Multiple sclerosis.
- •Documented episode in the medical record of a seizure occurring 1 month or more post stroke for which the patient received consultation or treatment for said seizures. Seizures occurring within the first month following a stroke are not exclusionary unless followed by another seizure.
- •Fixed ankle plantar flexor contracture, peroneal nerve injury at the fibular head as the cause of foot-drop.
- •History of dementia, severely impaired cognition, communication or comprehension deficits.
- •Presence of severe or frequent headaches
- •History of Botulinum toxin (Botox) injection to either of the lower extremities within the 3 month period preceding study entry.
- •Have other medical conditions or are taking medications that compromise ambulation or balance.
Outcomes
Primary Outcomes
Ankle Dorsiflexion Angle. Change From Baseline in Ankle Dorsiflexion Angle During the Swing Phase of Gait
Time Frame: Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).
Over ground laboratory assessments of gait: 1) Gait velocity and spatiotemporal gait parameters will be measured with the GAITRite system (CIR Systems, Inc., Havertown, PA) 28-35. 2) Hip, ankle, and knee angles during gait will be measured using the Simi Aktisys gait analysis system (Simi Reality Motion Systems; Postfach, Unterschleissheim Germany). LED markers are placed on the participant's lower extremity. Ankle, knee, and hip angle data is obtained simultaneously to evaluate motor strategies for overcoming gait impairments. Both types of data will be collected simultaneously as participants walk 10 meters across the GAITRite walkway at a self-selected speed for 5 repetitions.
Secondary Outcomes
- Slope of Recruitment Curve. Change From Baseline in the Slope of the Recruitment Curve Based on Motor Evoked Potentials (MEPs).(Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).)
- Change From Baseline in Stroke Impact Scale Scores(Study week 1, and study weeks 5(± 5 days) and 8 (± 10 days).)