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Cortical Priming to Optimize Gait Rehabilitation Post Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
AMT
Treadmill training
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Gait, Brain stimulation, tDCS, Walking

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The University of Illinois at Chicago

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Arm Label

tDCS+AMT

tDCS

AMT

Control

Arm Description

TDCS in combination with movement training before treadmill training

tDCS only before treadmill training

Movement training only before treadmill training

No priming before treadmill training

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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 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 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 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.

Full Information

First Posted
March 9, 2018
Last Updated
August 25, 2022
Sponsor
University of Illinois at Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03492229
Brief Title
Cortical Priming to Optimize Gait Rehabilitation Post Stroke
Official Title
Cortical Priming to Optimize Gait Rehabilitation Post Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Gait, Brain stimulation, tDCS, Walking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS+AMT
Arm Type
Experimental
Arm Description
TDCS in combination with movement training before treadmill training
Arm Title
tDCS
Arm Type
Active Comparator
Arm Description
tDCS only before treadmill training
Arm Title
AMT
Arm Type
Active Comparator
Arm Description
Movement training only before treadmill training
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
No priming before treadmill training
Intervention Type
Other
Intervention Name(s)
tDCS
Intervention Description
1 mA of tDCS
Intervention Type
Other
Intervention Name(s)
AMT
Intervention Description
Ankle motor training
Intervention Type
Behavioral
Intervention Name(s)
Treadmill training
Intervention Description
High intensity treadmill training
Primary Outcome Measure Information:
Title
Change in gait speed using 10 meter walk test
Description
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).
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up
Secondary Outcome Measure Information:
Title
Change in 6 minute walk test
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up
Title
Change in Berg Balance Scale
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up
Title
Change in Quality of life measures
Description
QOL will be measured with the Stroke Impact Scale (SIS). The SIS is a stroke-specific self-reported health status measure.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up
Title
Change in cortical excitability of leg muscles using TMS
Description
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.
Time Frame
Change from baseline to immediately after training and baseline to 3 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sangeetha Madhavan
Organizational Affiliation
UIC
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32799922
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.
Results Reference
derived

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Cortical Priming to Optimize Gait Rehabilitation Post Stroke

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