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| Name | Class |
|---|---|
| University of Maryland, College Park | OTHER |
| Northwestern University | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Priming+HIISTT | Experimental | Facilitatory transcranial direct current stimulation (tDCS) and ankle motor training before high intensity interval speed based treadmill training |
|
| Sham+HIISTT | Sham Comparator | Sham tDCS before high intensity interval speed based treadmill training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial direct current stimulation (tDCS) | Other | 1 mA tDCS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Walking 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). | Change from baseline to immediately after training and baseline to 3 months follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Walking spatiotemporal characteristics with GAITRite walkway | Spatiotemporal parameters of walking will be assessed using a 7m long pressure sensitive mat (GAITRite walkway). | Change from baseline to immediately after training and baseline to 3 months follow up |
| Motor impairment with Fugl Meyer Lower Extremity Scale |
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Inclusion Criteria:
Exclusion Criteria:
General exclusion criteria
TMS exclusion criteria
tDCS exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sangeetha Madhavan | Contact | 3123552517 | smadhava@uic.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sangeetha Madhavan | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Therapy | Recruiting | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38709654 | Derived | Cleland BT, Madhavan S. The Association of Interlimb Coordination and Temporal Symmetry With Walking Function and Motor Impairment After Stroke. Am J Phys Med Rehabil. 2024 Dec 1;103(12):1104-1109. doi: 10.1097/PHM.0000000000002522. Epub 2024 May 6. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| 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. |
|
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 |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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). | 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. | 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. | 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, | Change from baseline to immediately after training and baseline to 3 months follow up. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |