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NCT Number: NCT04477330

Cortical Priming to Optimize Gait Rehabilitation in Stroke: a 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Sangeetha Madhavan

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Other

1 mA tDCS

Ankle motor training

Other

Visuomotor target tracking task

High intensity interval speed based treadmill training (HIISTT)

Behavioral

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

Primary outcomes

  1. Walking speed with 10 meter walk test

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

    Self-selected and fastest gait speed will be measured as the average of 3 trials of the 10-m walk test (10MWT).

Secondary outcomes

  1. Walking spatiotemporal characteristics with GAITRite walkway

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

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

  2. Motor impairment with Fugl Meyer Lower Extremity Scale

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

    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

  3. Walking endurance with 6-minute walk test

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

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

  4. Ankle range of motion

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

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

  5. Ankle motor control

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

    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.

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

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

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

  7. Aerobic capacity

    Time frame: Change from baseline to immediately after training.

    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.

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

    Time frame: Change from baseline to immediately after training.

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

  9. Disability with Modified Rankin Scale

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

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

  10. Community ambulation with wearable sensors

    Time frame: Change from baseline to immediately after training.

    Daily ambulation will be assessed using an accelerometer.

  11. Serum brain derived neurotrophic growth factor (BDNF)

    Time frame: Change from baseline to immediately after training.

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

  12. Corticomotor excitability using transcranial magnetic stimulation

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

    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).

  13. Cognitive function using Mini Mental Screening Examination

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

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

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

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

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

  15. Modified Ashworth Scale

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sangeetha Madhavan

CONTACT

[email protected]

3123552517

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Northwestern University
  • University of Maryland, College Park

Registry information

Official study title

Cortical Priming to Optimize Gait Rehabilitation: Renewal

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2020
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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