Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT05535257
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT05535257
Study Brief:
Protocol Section:
NCT05535257