A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis (NCT05535257) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis
United States20 participantsStarted 2022-09-27
Plain-language summary
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.
Who can participate
Age range18 Years – 100 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ar…
What they're measuring
1
Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.