Clinical trial NCT03492229: Cortical Priming to Optimize Gait Rehabilitation Post Stroke
Official title: Cortical Priming to Optimize Gait Rehabilitation Post Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Gait
Brain stimulation
tDCS
Walking
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-04-10
Enrollment: 81
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in gait speed using 10 meter walk test
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up
Secondary outcomes:
measure: Change in 6 minute walk test
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up
measure: Change in Berg Balance Scale
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up
measure: Change in Quality of life measures
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up
measure: Change in cortical excitability of leg muscles using TMS
timeFrame: Change from baseline to immediately after training and baseline to 3 months follow up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: UIC
name: Sangeetha Madhavan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Madhavan S, Cleland BT, Sivaramakrishnan A, Freels S, Lim H, Testai FD, Corcos DM. Cortical priming strategies for gait training after stroke: a controlled, stratified trial. J Neuroeng Rehabil. 2020 Aug 17;17(1):111. doi: 10.1186/s12984-020-00744-9.