Stroke
Conditions
Keywords
tDCS, Walking
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.
Interventions
OTHERTranscranial direct current stimulation (tDCS)
1 mA tDCS
OTHERAnkle motor training
Visuomotor target tracking task
BEHAVIORALHigh intensity interval speed based treadmill training (HIISTT)
Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
Sponsors
University of Illinois at Chicago
University of Maryland, College Park
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Community ambulation with wearable sensors | Change from baseline to immediately after training. | Daily ambulation will be assessed using an accelerometer. |
| 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. |
| 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. |
| 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, |
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
CONTACTSangeetha Madhavan
PRINCIPAL_INVESTIGATORSangeetha Madhavan
University of Illinois at Chicago
Outcome results
None listed