NCT05535257Completed
A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis
Pilot Study to Establish Use of Lower Extremity Sleeve and Sequential Compression Pump Device in Patients With Upper Extremity Weakness Post-Stroke
Source: ClinicalTrials.gov · Last updated 9 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 19 Aug 2022
- Start date
- 27 Sept 2022
- Primary completion date
- 14 Nov 2023
- Lead sponsor
- Mayo Clinic
- Diseases
- Stroke
- NCT number
- NCT05535257
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 27 Sept 2022 to the primary completion date, 14 Nov 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have received thrombolytic therapeutic medicine administered \< 13 hours (per site specific policy) prior to application of SCD sleeve.
Other illness
- 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.
- Upper extremity including axillary or subclavian veins; open or active wounds or infection in the involved 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.
Other
- Inability to provide consent of participation.
- Subjects with aphasia or the inability to effectively communicate their pain consistently.
- Recent skin graft in the involved extremity.
- Confirmed DVT in the affected.
- Upper extremity ischemia, gangrene, cellulitis or severe arteriosclerosis in the affected 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C Joseph Yelvington Coordinator of this site? Confirm its status | Saint Johns | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.