Cortical Priming to Optimize Gait Rehabilitation: Renewal

University of Illinois at Chicago1 site in 1 country100 target enrollmentSeptember 1, 2020

ConditionsStroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stroke
Sponsor: University of Illinois at Chicago
Enrollment: 100
Locations: 1
Primary Endpoint: Walking speed with 10 meter walk test
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2020

End Date

December 31, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Illinois at Chicago

Responsible Party

Principal Investigator

Sangeetha Madhavan

Professor

University of Illinois at Chicago

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Walking endurance with 6-minute walk test(Change from baseline to immediately after training and baseline to 3 months follow up)
Balance with mini Balance Evaluations Systems Test (miniBESTest)(Change from baseline to immediately after training and baseline to 3 months follow up.)
Community ambulation with wearable sensors(Change from baseline to immediately after training.)
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)
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)
Aerobic capacity(Change from baseline to immediately after training.)
Quality of Life with EuroQol-5D (EQ-5D)(Change from baseline to immediately after training.)
Depression using Patient Health Questionnaire-9 (PHQ-9)(Change from baseline to immediately after training and baseline to 3 months follow up.)
Disability with Modified Rankin Scale(Change from baseline to immediately after training and baseline to 3 months follow up.)
Serum brain derived neurotrophic growth factor (BDNF)(Change from baseline to immediately after training.)
Corticomotor excitability using transcranial magnetic stimulation(Change from baseline to immediately after training and baseline to 3 months follow up.)
Cognitive function using Mini Mental Screening Examination(Change from baseline to immediately after training and baseline to 3 months follow up.)
Modified Ashworth Scale(Change from baseline to immediately after training and baseline to 3 months follow up.)