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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
1 mA tDCS
Visuomotor target tracking task
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Physical Therapy
Chicago, Illinois, United States
RECRUITINGWalking 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
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
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
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
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
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
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.
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.
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.
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.
Community ambulation with wearable sensors
Daily ambulation will be assessed using an accelerometer.
Time frame: Change from baseline to immediately after training.
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.
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.
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.
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.
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.
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