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Clinical Trials/NCT03492229
NCT03492229
Completed
Not Applicable

Cortical Priming to Optimize Gait Rehabilitation Post Stroke

University of Illinois at Chicago1 site in 1 country81 target enrollmentJanuary 1, 2014
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
University of Illinois at Chicago
Enrollment
81
Locations
1
Primary Endpoint
Change in gait speed using 10 meter walk test
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2014
End Date
August 15, 2020
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sangeetha Madhavan

Associate Professor

University of Illinois at Chicago

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

Outcomes

Primary Outcomes

Change in gait speed using 10 meter walk test

Time Frame: Change from baseline to immediately after training and baseline to 3 months follow up

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).

Secondary Outcomes

  • Change in Quality of life measures(Change from baseline to immediately after training and baseline to 3 months follow up)
  • Change in 6 minute walk test(Change from baseline to immediately after training and baseline to 3 months follow up)
  • Change in cortical excitability of leg muscles using TMS(Change from baseline to immediately after training and baseline to 3 months follow up)
  • Change in Berg Balance Scale(Change from baseline to immediately after training and baseline to 3 months follow up)

Study Sites (1)

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