Gait, Hemiplegic Clinical Trial
— GaitOfficial title:
Effect of Brain Stimulation on Motor Skill Acquisition in Stroke Survivors and Healthy Adults
Participants are being asked to participate in a research study conducted by Shih-Chiao
Tseng, PT, Ph.D. at Texas Woman's University. This research study is to determine whether
low-intensive brain stimulation can enhance learning of a leg movement task. The
investigators also want to know if brain stimulation can improve the nerve function and
walking performance. Our goal is to understand any relationship between brain stimulation and
overall movement control improvement. Participants have been invited to join this research if
they have had a stroke before or they are healthy adults aged 21 years or older. Research
evidence shows stroke can induce permanent brain damage and therefore may cause a person to
have trouble learning a new task. This in turn may significantly impact the recovery of motor
function in stroke survivors. In addition, the investigators also want to know how a healthy
person learns this new leg task and see if her/his learning pattern differs from a stroke
survivor.
This study comprises two phases: Phase I study investigates short-term effects of brain
stimulation on leg skill learning and only requires two visits to TWU. The total time
commitment for Phase I study will be about 6.5 hours, 3.5 hours on the first visit and three
hours on the second visit; Phase II study is an expanded version of Phase I study to
investigate long-term effects of brain stimulation on leg skill learning and requires to
complete 12 visits of exercise training paired with brain stimulation over a four-week period
and additional one visit for follow-up test. The total time commitment for Phase II study
will be about 20 hours, a total of 18 hours for 12 exercise training sessions and two hours
for a follow-up test. The investigators hypothesize that people with chronic stroke will show
a slower rate of acquiring this leg skill as compared to healthy adults. The investigators
also hypothesize that co-applying brain stimulation with 12 sessions of exercise training
will enhance skill learning of this leg task for people with chronic stroke and this
12-session exercise program may exert beneficial influences on the nerve function and leg
muscle activation, and consequentially improve motor control for walking.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Healthy adults have no ongoing neurological, musculoskeletal issues. - Individuals with chronic stroke had medical history of a unilateral stroke occurring = 6 months prior to enrollment. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract. - Individuals with chronic stroke have hemiparesis involving the lower extremity. - Individuals with chronic stroke have no passive range of motion limitation in bilateral hips and knees. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or ess. - Visual acuity can be corrected by glasses or contact lens to 20/20. - Able to walk independently with/without assistant devices for 10 meters. - Able to maintain standing position without any assistance for more than 30 sec. - Evaluation of cognitive status: Mini-mental status examination (MMSE) score = 24. Exclusion Criteria: - Pregnant women. - MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors. - Have any metal implants, cardiac pacemakers, or history of seizures. - Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training. - Any vestibular dysfunction or unstable angina. - Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia* |
Country | Name | City | State |
---|---|---|---|
United States | Texas Woman's University | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Woman's University |
United States,
Matsumoto H, Ugawa Y. Adverse events of tDCS and tACS: A review. Clin Neurophysiol Pract. 2016 Dec 21;2:19-25. doi: 10.1016/j.cnp.2016.12.003. eCollection 2017. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in stepping reaction time (Phase I) | Calculate the time duration for the central nervous system to process information and produce a stepping action. | Measure changes in the reaction time before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation. | |
Primary | Changes in stepping reaction time (Phase II) | Calculate the time duration for the central nervous system to process information and produce a stepping action. | Measure changes in reaction time before training, up to 24 hours after the completion of a 12-session training program, and one week after the completion of a 12-session training program. | |
Primary | Changes in walking performance (Phase I) | Measure walking speed (meters/second) during ground walking at a self-selected speed. | Measure changes in the walking speed before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation. | |
Primary | Changes in walking performance (Phase I) | Measure step length (centimeters) symmetry (left/right) during ground walking at a self-selected speed. | Measure changes in the step length symmetry before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation. | |
Primary | Changes in walking performance (Phase II) | Measure walking speed (meters/second) during ground walking at a self-selected speed. | Measure changes in the walking speed before training, up to 24 hours after the completion of a 12-session training program, and one week after the completion of a 12-session training program. | |
Primary | Changes in walking performance (Phase II) | Measure step length symmetry (left/right) during ground walking at a self-selected speed. | Measure changes in the step length symmetry before training, up to 24 hours after the completion of a 12-session training program, and one week after the completion of a 12-session training program. | |
Primary | Changes in nerve function (Phase I) | Place a surface electrode on the calf muscle to record muscle activation triggered by electrical stimulation delivered to the motor neurons in the lesioned motor cortex and tibial nerve on the paretic leg to qualify changes in neuronal activity in the primary cortex and in the spinal cord before and after brain stimulation (tDCS). | Measure changes in the nerve function before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation. | |
Primary | Changes in nerve function (Phase II) | Place a surface electrode on the calf muscle to record muscle activation triggered by electrical stimulation delivered to the motor neurons in the lesioned motor cortex and tibial nerve on the paretic leg to qualify changes in neuronal activity in the primary cortex and in the spinal cord before and after brain stimulation (tDCS). | Measure changes in the nerve function before training, up to 24 hours after the completion of a 12-session training program), and one week after the completion of a 12-session training program. | |
Secondary | Mini-mental State Examination (Phase I) | A standardized questionnaires to evaluate the cognitive function consisting of 11 items with a possible summed score ranging from zero to 30. The most widely accepted and frequently used cutoff score for the MMSE is 23, with scores of 23 or lower indicating the presence of cognitive impairment. A higher score means a better cognitive function. | Administer Mini-mental State Examination at the first visit before testing and training | |
Secondary | Mini-mental State Examination (Phase II) | A standardized questionnaires to evaluate the cognitive function consisting of 11 items with a possible summed score ranging from zero to 30. The most widely accepted and frequently used cutoff score for the MMSE is 23, with scores of 23 or lower indicating the presence of cognitive impairment.A higher score means a better cognitive function. | Administer Mini-mental State Examination at the first visit before testing and training | |
Secondary | Fugl-Meyer Lower Extremity Function Assessment (Phase I) | A standardized questionnaires to evaluate the lower extremity motor function consisting of movement, coordination, and reflex assessments at hip, knee, and ankle. Possible summed scores range from zero to 34. Higher scores indicate higher and better motor function. | Administer Fugl-Meyer Lower Extremity Function Assessment at the first visit before testing and training | |
Secondary | Fugl-Meyer Lower Extremity Function Assessment (Phase II) | A standardized questionnaires to evaluate the lower extremity motor function consisting of movement, coordination, and reflex assessments at hip, knee, and ankle. Possible summed scores range from zero to 34. Higher scores indicate higher and better motor function. | Administer Fugl-Meyer Lower Extremity Function Assessment at the first visit before testing and training |
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