Cortical Priming to Optimize Gait Rehabilitation Post Stroke
2 other identifiers
interventional
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Jan 2014
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
March 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2020
CompletedAugust 29, 2022
August 1, 2022
5.8 years
March 9, 2018
August 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Change from baseline to immediately after training and baseline to 3 months follow up
Secondary Outcomes (4)
Change in 6 minute walk test
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
Change in Quality of life measures
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
Study Arms (4)
tDCS+AMT
EXPERIMENTALTDCS in combination with movement training before treadmill training
tDCS
ACTIVE COMPARATORtDCS only before treadmill training
AMT
ACTIVE COMPARATORMovement training only before treadmill training
Control
SHAM COMPARATORNo priming before treadmill training
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Illinois at Chicago
Chicago, Illinois, 60612-7246, United States
Related Publications (1)
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.
PMID: 32799922DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sangeetha Madhavan
UIC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 9, 2018
First Posted
April 10, 2018
Study Start
January 1, 2014
Primary Completion
October 31, 2019
Study Completion
August 15, 2020
Last Updated
August 29, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share