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Completed

NCT Number: NCT03492229

Cortical Priming to Optimize Gait Rehabilitation Post Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Illinois at Chicago

Chicago, Illinois, 60612-7246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tDCS

Other

1 mA of tDCS

AMT

Other

Ankle motor training

Treadmill training

Behavioral

High intensity treadmill training

Primary outcomes

  1. 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

  1. Change in 6 minute walk test

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

    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.

  2. Change in Berg Balance Scale

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

    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.

  3. Change in Quality of life measures

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

    QOL will be measured with the Stroke Impact Scale (SIS). The SIS is a stroke-specific self-reported health status measure.

  4. Change in cortical excitability of leg muscles using TMS

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

    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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Apr 10, 2018
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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