N/A
N=20
A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis
Upper Extremity Weakness · Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05535257 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Wearing Tolerance of the SCD and Sleeve on the Upper Extremity. — 20 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sequential Compression Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wearing Tolerance of the SCD and Sleeve on the Upper Extremity. |
20 | — |
| SECONDARY Pain With SCD Sleeve and Device |
20 | — |
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.
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.
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.