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

Completed · Not applicable

Conditions studied: Upper Extremity Weakness, Stroke

In brief

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.

Key facts

Study ID

NCT05535257

Run by

Mayo Clinic

People needed

20

Starts

2022-09-27

Expected to finish

2023-11-14

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• C Joseph Yelvington — Saint Johns, Florida, United States

Full record on ClinicalTrials.gov

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