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StrokeNCT04477330

Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

A study testing Transcranial direct current stimulation (tDCS), Ankle motor training and High intensity interval speed based treadmill training (HIISTT) in people with Stroke, run by University of Illinois Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
Transcranial direct current stimulation (tDCS), Ankle motor training and High intensity interval speed based treadmill training (HIISTT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited States
Study dates
1 Sep 2020to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sangeetha Madhavan contact

3123552517

smadhava@uic.edu

United States1 site, 1 recruiting

  • Physical Therapy

    Chicago, Illinois, 60612

    Sangeetha Madhavan, brainlab@uic.edu

    Recruiting

Other trials in United States

About this study

Official title: Cortical Priming to Optimize Gait Rehabilitation: Renewal

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.

Conditions
Stroke
Being tested
Transcranial direct current stimulation (tDCS), Ankle motor training, High intensity interval speed based treadmill training (HIISTT)
Keywords
tDCS, Walking
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial direct current stimulation (tDCS)Other

    1 mA tDCS

  • Ankle motor trainingOther

    Visuomotor target tracking task

  • High intensity interval speed based treadmill training (HIISTT)Behavioural

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

Study groups in NCT04477330
Study groupRoleWhat they receive
Priming+HIISTTExperimentalFacilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training
Receives: Other: Transcranial direct current stimulation (tDCS); Other: Ankle motor training; Behavioral: High intensity interval speed based treadmill training (HIISTT)
Sham+HIISTTSham comparatorSham tDCS before high intensity interval speed based treadmill training
Receives: Behavioral: High intensity interval speed based treadmill training (HIISTT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (15)

  1. Walking spatiotemporal characteristics with GAITRite walkway

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

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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,

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start1 Sep 2020
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477330
Sponsor's protocol ID
2020-0502
Status last verified
Aug 2025
First submitted
9 Jul 2020
Last updated
11 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial direct current stimulation (tDCS), Ankle motor training and High intensity interval speed based treadmill training (HIISTT) in people with Stroke, run by University of Illinois Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sangeetha Madhavan (3123552517, smadhava@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Walking speed with 10 meter walk test (time frame: Change from baseline to immediately after training and baseline to 3 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477330, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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