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

NCT05535257 | Completed Results FDA Device

• 1 other identifier: 21-009068
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Upper Extremity Weakness; Stroke

Outcome Measures

Primary Outcomes (1)

• Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.

  Number of subjects who answered yes to the question "Are you tolerating this sleeve"

  4 hours

Secondary Outcomes (1)

• Pain With SCD Sleeve and Device

  4 hours

Other Outcomes (6)

• Nail Bed Color

  4 hours

• Edema Measured in Inches of Circumference of Forearm

  4 hours

• UE Strength Using Motor Arm Subsection #5 of NIH Scale

  4 hours

Study Arms (1)

Sequential Compression Device (SCD) on upper extremity

EXPERIMENTAL

Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only

Device: Sequential Compression Device

Interventions

Sequential Compression Device DEVICE

Calf size lower extremity sequential compression device sleeve will be placed on the weak upper extremity blow the cubital fossa and may include the hand if necessary. The device will inflate and deflate.

Also known as: SCD

Sequential Compression Device (SCD) on upper extremity

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 score \> 13 on the BIMS to ensure intact cognition.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

C Joseph Yelvington

Saint Johns, Florida, 32259, United States

Location

MeSH Terms

Conditions

Paresis; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Suzanne Langley OTR/L
• Organization: Mayo Clinic Florida

langley.suzanne@mayo.edu

9044724288

Study Officials

• Suzanne Langley, OT

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: September 10, 2022
• Study Start: September 27, 2022
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)