A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis

Study Overview
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Brief Summary
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The primary purpose of this study is to establish that application of a Sequential Compression Device (SCD) and lower extremity (LE) sleeve applied to a hemi-paretic upper extremity is safe.

Detailed Description
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Studies has shown that passively stimulating the arm with vibration can improve sensory and motor recovery and movement. Researchers want to expand on this with a more advanced stimulation but in a device that is already routinely used. The SCD is normally used to prevent blood clots. It uses pressure to keep blood moving in the leg. It is routinely used in hospitals across the country. While it does this it warms and even vibrates the leg giving many types of stimulation to the limb and to the brain. This stimulation may help improve recovery further, at marginal cost, while possibly reducing the chances of blood clots in an immobile limb.

Official Title
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Pilot Study to Establish Use of Lower Extremity Sleeve and Sequential Compression Pump Device in Patients With Upper Extremity Weakness Post-Stroke

Conditions
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Upper Extremity Weakness, Stroke

Intervention / Treatment
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* Device: Sequential Compression Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients admitted to Mayo Clinic/Jacksonville, post-stroke with a hemiparetic upper extremity. Able to provide consent of participation by self-agreement. Patients with a hemiparetic upper extremity will be determined using the NIH Motor Arm subsection from the NIH scale and score a 1-4. Patients who have received thrombolytic therapeutic medicine > 13 hours (per site specific policy) will not be excluded from inclusion in this study. Patients who score > 13 on the BIMS to ensure intact cognition. Exclusion Criteria: Inability to provide consent of participation. Subjects with aphasia or the inability to effectively communicate their pain consistently. Questionable reliability scoring < 13 on the BIMS, has an existing invasive line (PICC line, IV, AV fistula or AV graft); recent surgery or vein ligation in the involved extremity. Recent skin graft in the involved extremity. Confirmed DVT in the affected. Upper extremity including axillary or subclavian veins; open or active wounds or infection in the involved extremity. Upper extremity ischemia, gangrene, cellulitis or severe arteriosclerosis in the affected upper extremity. Status-post axillary lymph node dissection on the involved side; congestive heart failure (CHF) acute exacerbation; acute edema of unknown etiology in the involved upper extremity. Subjects with extreme deformity of the affected upper extremity. Subjects with an acute kidney injury. Subjects who are hemodynamically unstable 1,7,17. Patients who have received thrombolytic therapeutic medicine administered < 13 hours (per site specific policy) prior to application of SCD sleeve.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequential Compression Device (SCD) on upper extremity<br>Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only | Device: Sequential Compression Device<br>* Calf size lower extremity sequential compression device sleeve will be placed on the weak upper extremity blow the cubital fossa and may include the hand if necessary. The device will inflate and deflate.<br>* Other names: SCD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wearing tolerance of the SCD and sleeve on the upper extremity. | Number of subjects out of 20 participants able to wear the SCD on the weak upper extremity for the complete duration of study participation will be determined based off patient self reporting from question Are you tolerating this sleeve Yes (Y) or No (N). 20 patients are to be included in this study, with goal of 0 participants with adverse affects of any grade as of result of wearing the sleeve. Patients that report No (N) to tolerance of the sleeve question above will be excluded at time of reporting and sleeve removed. | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with SCD sleeve and device | Pain values measured by Visual Analogue Scale (VAS) where patient identifies pain on a a line between no pain and worst possible pain. | 4 hours |