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RecruitingNCT04477330Updated May 11, 2026

Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

An interventional study of Transcranial direct current stimulation (tDCS) and Ankle motor training in Stroke, sponsored by University of Illinois at Chicago. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2020; still recruiting 6 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Stroke

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Keywords

  • tDCS
  • Walking
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • General exclusion criteria

    • 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

TMS exclusion criteria

  • 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
  • Skull abnormalities or fractures
  • Concussion within the last 6 months
  • Currently pregnant

tDCS exclusion criteria

  • Skin hypersensitivity
  • History of contact dermatitits
  • History of allodynia and/or hyperalgesia
  • Any other skin or scalp condition that could be aggravated by tDCS
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Priming+HIISTT

    Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training

    Other: Transcranial direct current stimulation (tDCS) · Other: Ankle motor training · Behavioral: High intensity interval speed based treadmill training (HIISTT)

  • Sham comparator
    Sham+HIISTT

    Sham tDCS before high intensity interval speed based treadmill training

    Behavioral: High intensity interval speed based treadmill training (HIISTT)

Interventions

  • OtherTranscranial direct current stimulation (tDCS)

    1 mA tDCS

  • OtherAnkle motor training

    Visuomotor target tracking task

  • BehavioralHigh intensity interval speed based treadmill training (HIISTT)

    Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.

06

What researchers measure

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).

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

Secondary outcomes

  1. Walking spatiotemporal characteristics with GAITRite walkway

    Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway).

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

  2. Motor impairment with Fugl Meyer Lower Extremity Scale

    Lower extremity impairment will be measured using the Fugl Meyer Lower Extremity Scale (FMLE), a series of tests of movement, reflex activity, coordination/speed, sensation, and range of motion. The maximum score is 34 and a high score indicates less impairment

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

  3. Walking endurance with 6-minute walk test

    Walking endurance will be measured using the 6-Minute Walk test. Participants will walk as far as possible within 6 minutes.

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

  4. Ankle range of motion

    Ankle range of motion will be measured using a wireless electrogoniometer affixed to the ankle.

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

  5. Ankle motor control

    The participant will track a computer-generated sinusoidal target with ankle dorsiflexion and plantarflexion in a custom-built ankle-tracking device. Accuracy of tracking the target with ankle motion will be calculated.

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

  6. Balance with mini Balance Evaluations Systems Test (miniBESTest)

    Balance will be tested with the Mini-BESTest, involving 14 different tasks to challenge balance.

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

  7. Aerobic capacity

    Cardiopulmonary exercise tests will be performed on a motorized treadmill following an individualized protocol using standard procedures. Measures relating to peak oxygen consumption (VO2 max) will be calculated.

    Time frame: Change from baseline to immediately after training.

  8. Quality of Life with EuroQol-5D (EQ-5D)

    Quality of life will be measured with the EuroQol-5D (EQ-5D), a questionnaire with questions designed to assess aspects of quality of life.

    Time frame: Change from baseline to immediately after training.

  9. Disability with Modified Rankin Scale

    Global disability will be measured with the modified Rankin Scale, a simple 0-6 rating scale.

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

  10. Community ambulation with wearable sensors

    Daily ambulation will be assessed using an accelerometer.

    Time frame: Change from baseline to immediately after training.

  11. Serum brain derived neurotrophic growth factor (BDNF)

    5 ml of blood will be collected from a vein in the participants' arms

    Time frame: Change from baseline to immediately after training.

  12. Corticomotor excitability using transcranial magnetic stimulation

    Corticomotor excitability of the paretic and non-paretic lower limb muscles such as the tibialis anterior and soleus muscle representations will be measured with single pulse transcranial magnetic stimulation (TMS).

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

  13. Cognitive function using Mini Mental Screening Examination

    30-point questionnaire used to capture orientation, attention, memory and language.

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

  14. Depression using Patient Health Questionnaire-9 (PHQ-9)

    The 9-point questionnaire is used to measure degree of depression.

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

  15. Modified Ashworth Scale

    The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion,

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

07

Study locations

1 of 1 sites recruiting
  • Physical Therapy
    Chicago, Illinois 60612, United States
    Recruiting
08

References and documents

Publications

  • 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. PubMed 38709654 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04477330
Lead sponsor
University of Illinois at Chicago
Collaborators
University of Maryland, College Park, Northwestern University
Responsible party
Sangeetha Madhavan (Professor, University of Illinois at Chicago) — Principal investigator
First posted
Jul 20, 2020
Start date
Sep 1, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
May 11, 2026

Study contacts

Sangeetha Madhavan
Contact
smadhava@uic.edu
3123552517
Sangeetha Madhavan
principal investigator · University of Illinois at Chicago

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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