Cortical Priming to Optimize Gait Rehabilitation Post Stroke

August 25, 2022 updated by: Sangeetha Madhavan, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612-7246
        • The University of Illinois at Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: tDCS+AMT
TDCS in combination with movement training before treadmill training
Other: tDCS
1 mA of tDCS
Other: AMT
Ankle motor training
Behavioral: Treadmill training
High intensity treadmill training
ACTIVE_COMPARATOR: tDCS
tDCS only before treadmill training
Other: tDCS
1 mA of tDCS
Behavioral: Treadmill training
High intensity treadmill training
ACTIVE_COMPARATOR: AMT
Movement training only before treadmill training
Other: AMT
Ankle motor training
Behavioral: Treadmill training
High intensity treadmill training
SHAM_COMPARATOR: Control
No priming before treadmill training
Behavioral: Treadmill training
High intensity treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
Change from baseline to immediately after training and baseline to 3 months follow up
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.
Change from baseline to immediately after training and baseline to 3 months follow up
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.
Change from baseline to immediately after training and baseline to 3 months follow up
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.
Change from baseline to immediately after training and baseline to 3 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

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

Investigators

  • Principal Investigator: Sangeetha Madhavan, UIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2014

Primary Completion (ACTUAL)

October 31, 2019

Study Completion (ACTUAL)

August 15, 2020

Study Registration Dates

First Submitted

March 9, 2018

First Submitted That Met QC Criteria

April 2, 2018

First Posted (ACTUAL)

April 10, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 29, 2022

Last Update Submitted That Met QC Criteria

August 25, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0676
  • R01HD075777 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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