Cortical Priming to Optimize Gait Rehabilitation Post Stroke

Study Overview
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Brief Summary
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Over four million stroke survivors currently living in the United States are unable to walk independently in the community. To increase the effectiveness of gait rehabilitation, it is critical to develop therapies that are based on an understanding of brain adaptations that occur after stroke. This project will be the first step towards the development of a novel therapeutic approach using brain stimulation to increase walking capacity in stroke survivors and understand the neural mechanisms that are associated with impairment and functional recovery.

Official Title
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Cortical Priming to Optimize Gait Rehabilitation Post Stroke

Conditions
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Stroke

Intervention / Treatment
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* Other: tDCS
* Other: AMT
* Behavioral: Treadmill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50 - 80 years First ever monohemispheric stroke > 6 months since onset Residual hemiparetic gait deficits Able to walk without an ankle orthotic for 5 minutes at self-paced speed. Handheld assistive device is acceptable. Exclusion Criteria: Severe osteoporosis Contracture-limiting range of motion of lower limb Uncontrolled anti-spasticity medications during the study period Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema) Unhealed decubiti, persistent infection Significant cognitive or communication impairment (MMSE <21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the tracking task. Lesions pertaining to the brainstem and cerebellum

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS+AMT<br>TDCS in combination with movement training before treadmill training | Other: tDCS<br>* 1 mA of tDCS<br>Other: AMT<br>* Ankle motor training<br>Behavioral: Treadmill training<br>* High intensity treadmill training<br>|
| Active Comparator: tDCS<br>tDCS only before treadmill training | Other: tDCS<br>* 1 mA of tDCS<br>Behavioral: Treadmill training<br>* High intensity treadmill training<br>|
| Active Comparator: AMT<br>Movement training only before treadmill training | Other: AMT<br>* Ankle motor training<br>Behavioral: Treadmill training<br>* High intensity treadmill training<br>|
| Sham Comparator: Control<br>No priming before treadmill training | Behavioral: Treadmill training<br>* High intensity treadmill training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gait speed using 10 meter walk test | 10-meter walk test: Gait speed will be measured as the average of 3 trials of the 10-m walk test. Participants will be asked to walk at their normal comfortable pace to cover a distance of 10 meters without an AFO (handheld assistive device is acceptable if needed). | Change from baseline to immediately after training and baseline to 3 months follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minute walk test | The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. Participants will be asked to walk at their normal pace for 6 minutes. | Change from baseline to immediately after training and baseline to 3 months follow up | 
| Change in Berg Balance Scale | Balance will be measured using the Berg Balance Scale. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Tasks such as standing with eyes closed, one leg stance etc are included. | Change from baseline to immediately after training and baseline to 3 months follow up | 
| Change in Quality of life measures | QOL will be measured with the Stroke Impact Scale (SIS). The SIS is a stroke-specific self-reported health status measure. | Change from baseline to immediately after training and baseline to 3 months follow up | 
| Change in cortical excitability of leg muscles using TMS | Transcranial magnetic stimulation will be used to measure contralateral and ipsilateral corticospinal excitability of the paretic tibialis anterior (TA) using the protocol previously published by the PI Dr. Madhavan. | Change from baseline to immediately after training and baseline to 3 months follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gait, Brain stimulation, tDCS, Walking