The primary study objectives are to assess the safety and feasibility of the therapy, including the surgical intervention and stimulation, as well as to provide information on the appropriateness of the study test measures (assessments) and to provide a basis for sample size calculations for a larger, pivotal study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
University of Minnesota
Minneapolis, Minnesota, United States
UT Southwestern
Dallas, Texas, United States
UT Houston
Houston, Texas, United States
Change in Upper Extremity Fugl-Meyer (UEFM)
Measurement of impairment, minimum value 0, maximum value 66, higher score means a better outcome. Subscales are summed.
Time frame: 6-weeks
Change in Wolf Motor Function Test Functional Assessment (WMFT)
Measurement of upper limb function/mobility. For Functional Assessment - minimum is 0 and maximum is 3. A higher score means a better outcome.
Time frame: 6-weeks
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