Arm Weakness as a Consequence of Stroke, Chronic Stroke Patients, Stroke
Conditions
Keywords
transcranial magnetic stimulation
Brief summary
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.
Interventions
DEVICEkTMP sham stimulation 9 weeks + active stimulation 9 weeks
kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation
DEVICEkTMP 18 weeks
Participants receive kTMP active stimulation for 18 weeks
Sponsors
University of California, San Francisco
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults age 18-80 years old who have had a stroke resulting in hemiplegia * Ability to communicate, understand, and give appropriate consent * Other criteria may apply
Exclusion criteria
* Significant cognitive impairment * inability to adhere to the study protocol or provide informed consent * pregnancy * additional criteria may apply
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fugl Meyer Assessment | Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
| Stroke Impact Scale | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
| Stroke Specific QOL | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
| EuroQOL | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
| Motor Activity Log | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
| Modified Ashworth Scale Scores | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
| Action Research Arm Test | At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34 | 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. |
Countries
United States
Contacts
CONTACTKarunesh Ganguly, MD, PhD
PRINCIPAL_INVESTIGATORKarunesh Ganguly, MD, PhD
University of California, San Francisco
Outcome results
None listed