A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 21-009068
NCT ID: NCT05535257
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Suzanne Langley, O.T. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available