Status:

RECRUITING

Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal

Lead Sponsor:

University of Illinois at Chicago

Collaborating Sponsors:

University of Maryland, College Park

Northwestern University

Conditions:

Stroke

Eligibility:

All Genders

18+ years

Phase:

NA

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 b...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2025

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04477330

Start Date

September 1 2020

End Date

December 31 2025

Last Update

August 19 2025

Active Locations (1)

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Physical Therapy

Chicago, Illinois, United States, 60612