Cortical Priming to Optimize Gait Rehabilitation in Stroke: a Renewal
- Conditions
- Stroke
- Interventions
- Other: Transcranial direct current stimulation (tDCS)Other: Ankle motor trainingBehavioral: High intensity interval speed based treadmill training (HIISTT)
- Registration Number
- NCT04477330
- Lead Sponsor
- University of Illinois at Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Priming+HIISTT Ankle motor training Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training Priming+HIISTT High intensity interval speed based treadmill training (HIISTT) Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training Priming+HIISTT Transcranial direct current stimulation (tDCS) Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training Sham+HIISTT High intensity interval speed based treadmill training (HIISTT) Sham tDCS before high intensity interval speed based treadmill training
- Primary Outcome Measures
Name Time Method Walking speed with 10 meter walk test 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 Outcome Measures
Name Time Method Walking endurance with 6-minute walk test 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.
Balance with mini Balance Evaluations Systems Test (miniBESTest) 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.
Community ambulation with wearable sensors Change from baseline to immediately after training. Daily ambulation will be assessed using an accelerometer.
Walking spatiotemporal characteristics with GAITRite walkway 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).
Motor impairment with Fugl Meyer Lower Extremity Scale 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
Ankle range of motion 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.
Ankle motor control 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.
Aerobic capacity 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.
Quality of Life with EuroQol-5D (EQ-5D) 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.
Depression using Patient Health Questionnaire-9 (PHQ-9) 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.
Disability with Modified Rankin Scale 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.
Serum brain derived neurotrophic growth factor (BDNF) Change from baseline to immediately after training. 5 ml of blood will be collected from a vein in the participants' arms
Corticomotor excitability using transcranial magnetic stimulation 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).
Cognitive function using Mini Mental Screening Examination 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.
Modified Ashworth Scale 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,
Trial Locations
- Locations (1)
Physical Therapy
🇺🇸Chicago, Illinois, United States