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| ID | Type | Description | Link |
|---|---|---|---|
| R01NR016055 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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The primary aim of this proposal is to test the effectiveness of neuromuscular electrical stimulation (NMES) in improving functional status and muscle function in patients receiving prolonged mechanical ventilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuro-muscular electrical stimulation | Active Comparator | Intervention:Neuromuscular electrical stimulation (NMES) NMES stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering NMES |
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| Sham stimulation | Sham Comparator | Intervention: sham stimulation Sham stimulation will be applied to lower extremity muscle groups up to 5 days a week until discharge. Standard physical therapy will also be administered by a therapist distinct from the therapist administering sham-NMES |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular electrical Stimulation (NMES) | Device | Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach independence in performing functional activity | Functional activity as measured by functional activity measurement for the ICU (FSS-ICU) | Hospital discharge, an expected average stay of 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients who can perform functional activities independently | Percentage of patients with an FSS-ICU score ≥ 25 at discharge from LTACH | Hospital discharge, an expected average stay of 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa A Duffner, B.A.,B.S. | Contact | 630-286-4149 | lmikolajewski@rmlspecialtyhospital.org | |
| Amal Jubran, MD | Contact | 708-202-2705 | ajubran@lumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amal Jubran, MD | RML Specialty Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RML Specialty Hospital | Recruiting | Hinsdale | Illinois | 60521 | United States |
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| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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| Sham Stimulation | Device | Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). |
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| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |