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N/A Completed N=20 Health Services Research

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

Upper Extremity Weakness · Stroke
Source: ClinicalTrials.gov NCT05535257 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Wearing Tolerance of the SCD and Sleeve on the Upper Extremity. — 20 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.
20
SECONDARY
Pain With SCD Sleeve and Device
20

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05535257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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