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The recovery from a stroke is often incomplete. It is the leading cause of acquired permanent disability in the adult population. Persistent functional loss of the hand and arm contributes significantly to disability. However, the current standard of care to treat hand and arm movements are inadequate. There is an urgent need for innovative and effective therapies for recovery of the upper limb after stroke.
Growing evidence shows that electrical spinal cord stimulation, combined with activity-dependent rehabilitation, enables voluntary movement of paralyzed muscles in some neurologic disorders, such as spinal cord injury. The investigators hypothesize that spinal networks that lost control after stroke can be activated by non-invasive electrical stimulation of the spinal cord to improve functional recovery.
The aims of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity Based Rehabilitation | Active Comparator | Activity Based Rehabilitation is comprised of intensive, progressive, functional task practice. The protocol consists of repetitive activities of gross upper limb movement, isolated finger movements, bimanual task performance, simple and complex pinch, and grip performance. Several activities with various difficulty levels are designated for each category, and the participant will perform 1-2 activities within each category in each rehabilitation session. Rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions). |
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| Non-invasive Electrical Spinal Cord Stimulation + Activity Based Rehabilitation | Experimental | Non-invasive electrical spinal cord stimulation will be performed using surface electrodes placed over the skin of the neck. Biphasic rectangular pulses of 1 millisecond per phase duration will be delivered with a 10 kiloHertz overlapping frequency and between 20-120 Hertzz burst frequency. Non-invasive electrical spinal cord stimulation will be paired with Activity Based Rehabilitation sessions. Stimulation plus rehabilitation sessions will be three times per week, 90 minutes per session for six weeks (total of 18 sessions). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Electrical Spinal Cord Stimulation | Device | Electrical stimulation of the spinal cord using surface electrodes |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline - Fugl-Meyer assessment of the upper limb | The clinician-administered a stroke-specific, performance-based impairment scale. It assesses movement function, sensation, joint range of motion, and pain. The score ranges from 0 to 66. Higher scores indicate better outcomes. | "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." |
| Change from baseline - Pinch and grip force | Measurement of hand strengths using a dynamometry. | "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." |
| Change from baseline - Modified Ashworth Scale | Clinician-administered test for resistance of a joint to passive movement. This scale grades muscle tone/spasticity. The score ranges from 0 to 4. Higher scores indicate worse outcomes. | "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." |
| Change from baseline - Wolf Motor Function Test | Quantifies upper limb motor ability through timed and functional tasks. The score range is 0-75; higher scores denote better function. | "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline - Action Research Arm Test | Clinician-administered observational measure to assess upper extremity performance, such as coordination, dexterity, and functioning, in stroke recovery. | "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fatma Inanici | Contact | 206-787-2692 | finanici@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chet Moritz, PhD | University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington | Recruiting | Seattle | Washington | 98105 | United States |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Prospective, randomized, two-arm cross-over study: All participants will receive one of the two treatment arms one after the other. The order of the treatments will be randomized.
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| Activity Based Rehabilitation | Other | Exercise therapy targeting paralyzed hand and arm |
|
| Change from baseline - Box and Blocks Test |
Participants move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds. Measures gross manual dexterity. |
| "Measurements at baseline and repeated measurements once every two weeks throughout the study, an average of 8 months." |
| Change from baseline - Revised Nottingham Sensory Assessment | A standardized scale for assessing sensory impairment in stroke patients. Tactile sensation, proprioception, stereognosis, and two-point discrimination are evaluated. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| Change from baseline - Stroke Impact Scale | A self-report questionnaire that evaluates disability and health-related quality of life after stroke. The questionnaire consists of 8 domains: strength, memory and thinking, emotion, communication, activities of daily living, mobility, hand function, and participation/role function. The score ranges from 0 to 100. Higher scores indicate better outcomes. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| Change from baseline - Short Form-36 | A self-report health survey questionnaire. The score range from 0 to 100. The higher the score, the better the outcome. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| Change from baseline - Patients Global Impression of Change | A self-report measure that reflects the participant's belief about the efficacy of treatment: the participant chooses the level of improvement and their functional status between much worse, worse, no change, improved and much improved, compared to the baseline. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| Change from baseline - H-reflex test | Electrophysiologic evaluation of the reflex response triggered on the motor nerves when sensory fibers in the peripheral nerve are stimulated. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| Change from baseline - Somatosensory evoked potentials test | Electrophysiologic evaluation of sensory pathways between the brain and the limb. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| Change from baseline - Spinally evoked motor potentials test | Electrophysiologic evaluation of motor pathways between the central nervous system and the muscles. | "Repeated measurements once at baseline, once at the end of each treatment arm and through study completion, an average of 8 months." |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |