kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation
Participants receive kTMP active stimulation for 18 weeks
University of California, San Francisco
San Francisco, California, United States
Fugl Meyer Assessment
The Fugl-Meyer Assessment (FMA) is a structured evaluation used to measure motor recovery after a stroke, with a total score range of 0-226. Higher scores indicate better motor function, while lower scores reflect greater impairment.
Time frame: Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.
Wolf Motor Function Test
Measures timed functional tasks, strength testing, and analysis of movement quality when completing various upper extremity tasks. Uses a 6 point ordinal scale (0-5), where ) is does not attempt with the involved arm and 5 is arm does participate and movement appears normal. Maximum score of 75. Lower scores indicate lower functional levels.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Stroke Impact Scale
Self reported questionnaire that evaluates disability and health related quality of life after stroke, consisting of 59 items, assessing strength, hand function, ADL/iADL, mobility, communication, emotion, memory and thinking, participation/role function. Each item is rated in a 5 point Likert scale, where 1 equals could not do it at all and 5 equals not difficult at all. Score ranges 0-100. Higher score indicates less disability and high quality of life after stroke.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Stroke Specific QOL
Questionnaire consisting of 49 items in the 12 domains of mobility, energy, upper extremity function, work and productivity, mood, self-care, social roles, family roles, vision, language, thinking and personality. Each item is assessed on a 5 point Guttman type scale, where 1=total help; couldn't do it at all; strongly agree and 5 =no help needed; no trouble at all; strongly disagree. Higher scores indicate better functioning.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
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EuroQOL
A health questionnaire that measures 5 dimensions including mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each item is described by 3 levels of problems, where 1=none, 2=mild to moderate, and 3=severe. This provides a simple single index value for health status, where a higher score indicates worse health state.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Motor Activity Log
Self reported perception of Quality of movement are rated in 30 functional tasks, scored on a 6 point ordinal scale where 0=weaker arm not used at all for that activity and 5=ability to use the weaker arm for that activity is as good as before the stroke(normal). A higher score indicates better quality upper extremity movement.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Modified Ashworth Scale Scores
Test of resistance to passive movement about a joint, scores range from 0 to 5 where 0=no increase in muscle tone and 5=affected part(s) rigid. Hight scores indicate greater muscle tone.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34
Action Research Arm Test
Measures performance of the upper extremity in grasp, grip, pinch, and gross arm movements, rated on a 4 point ordinal scale where 3=performs test normally and 0=can perform no part of test. Higher score indicates greater function of the upper extremity.
Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34