Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal
1 other identifier
interventional
100
1 country
1
Brief Summary
Achieving functional ambulation post stroke continues to be a challenge for stroke survivors, clinicians, and researchers. In the effort to enhance outcomes of motor training, cortical priming using brain stimulation has emerged as a promising adjuvant to conventional rehabilitation. This project focuses on the development of a long term gait rehabilitation protocol using brain stimulation to improve walking outcomes in people with stroke. The project will also aim to understand the neural mechanisms that are associated with response to the intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Sep 2020
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
First Submitted
Initial submission to the registry
July 9, 2020
CompletedFirst Posted
Study publicly available on registry
July 20, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
May 11, 2026
August 1, 2025
6.3 years
July 9, 2020
May 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Walking speed with 10 meter walk test
Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).
Change from baseline to immediately after training and baseline to 3 months follow up
Secondary Outcomes (15)
Walking spatiotemporal characteristics with GAITRite walkway
Change from baseline to immediately after training and baseline to 3 months follow up
Motor impairment with Fugl Meyer Lower Extremity Scale
Change from baseline to immediately after training and baseline to 3 months follow up
Walking endurance with 6-minute walk test
Change from baseline to immediately after training and baseline to 3 months follow up
Ankle range of motion
Change from baseline to immediately after training and baseline to 3 months follow up
Ankle motor control
Change from baseline to immediately after training and baseline to 3 months follow up
- +10 more secondary outcomes
Study Arms (2)
Priming+HIISTT
EXPERIMENTALFacilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
Sham+HIISTT
SHAM COMPARATORSham tDCS before high intensity interval speed based treadmill training
Interventions
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Eligibility Criteria
You may qualify if:
- Age greater than 18 years
- First ever monohemispheric stroke \> 3 months since onset
- Residual hemiparetic gait deficits (e.g. abnormal gait pattern)
- Able to walk for 5 minutes at self-paced speed. Handheld assistive device is acceptable.
- Walking speed lesser than 1.2 m/s
- Lower limb Fugl-Meyer Motor score between 15-30
- At least 5 deg of ankle dorsiflexion necessary to perform the ankle-tracking task
You may not qualify if:
- Severe osteoporosis
- Contracture-limiting range of motion of lower limb
- Score of more than 2 on the Modified Ashworth Scale (indicating increased muscle tone through ankle range of motion)
- Uncontrolled anti-spasticity medications during the study period
- Score less than 6 on the Fugl-Meyer Sensory Assessment Scale for the Lower Limb
- Cardiorespiratory or metabolic diseases (e.g. cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
- Unhealed decubiti, persistent infection
- Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)\<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
- Lesions involving the brainstem and cerebellum
- Failure to pass the graded exercise stress test
- Implanted cardiac pacemaker
- Metal implants in the head or face
- Unexplained, recurring headaches
- History of seizures or epilepsy
- Currently under medication that could increase motor excitability and lower seizure threshold
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Illinois at Chicagolead
- University of Maryland, College Parkcollaborator
- Northwestern Universitycollaborator
Study Sites (1)
Physical Therapy
Chicago, Illinois, 60612, United States
Related Publications (1)
Cleland BT, Madhavan S. The Association of Interlimb Coordination and Temporal Symmetry With Walking Function and Motor Impairment After Stroke. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1104-1109. doi: 10.1097/PHM.0000000000002522. Epub 2024 May 6.
PMID: 38709654DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sangeetha Madhavan
University of Illinois at Chicago
Central Study Contacts
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
- Professor
Study Record Dates
First Submitted
July 9, 2020
First Posted
July 20, 2020
Study Start
September 1, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
May 11, 2026
Record last verified: 2025-08