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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Weakness
• Intervention / Treatment: Device: Sequential Compression Device

Detailed Description

Studies has shown that passively stimulating the arm with vibration can improve sensory and motor recovery and movement. Researchers want to expand on this with a more advanced stimulation but in a device that is already routinely used. The SCD is normally used to prevent blood clots. It uses pressure to keep blood moving in the leg. It is routinely used in hospitals across the country. While it does this it warms and even vibrates the leg giving many types of stimulation to the limb and to the brain. This stimulation may help improve recovery further, at marginal cost, while possibly reducing the chances of blood clots in an immobile limb.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Saint Johns, Florida, United States, 32259
      • C Joseph Yelvington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequential Compression Device (SCD) on upper extremity; 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; 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.; Other Names: SCD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain With SCD Sleeve and Device	Total number of subjects to report No pain measured by Visual Analogue Scale (VAS) where patient identifies pain on a line between "no pain" and "worst possible pain".	4 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nail Bed Color	Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color	4 hours
Edema Measured in Inches of Circumference of Forearm	Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.	4 hours
UE Strength Using Motor Arm Subsection #5 of NIH Scale	The limb is placed in the appropriate position: extend the arm (palm down) 90 degrees if sitting or 45 degrees if supine. Drift is scored if the arm falls before 10 seconds. Documenting using Scale definition: 0=No drift, 1=Drift, 2=Some effort against gravity, 3=No effort against gravity; limb falls, 4=No movement	4 hours
UE Sensation	Using cotton swab and lightly touching skin at dermatome points C2, C3, C4, C5, C6, C7, C8, T1, T2 using the International Standards for the Classification of Spinal Cord Injury Key Sensory Points documenting "Intact" or "Impaired"	4 hours
UE Skin Integrity	Prior to placement of sleeve and upon removal of sleeve during check time skin will be visually assessed and the terms "Intact" or "Impaired" will be documented. Any new "redness", "rash", or "bruising" and "area" of arm will be documented and the need to remove sleeve at that time will be determined.	4 hours
UE Grip Strength	Using dynamometer in pounds measures affected hand strength at baseline and at 4-hours for each subject. This outcome measure was added approximately 1/2 way through the subject recruitment as a revision to this study to help capture subjects with hand weakness who may not have gross arm weakness (captured by Motor arm Subsection #5 outcome measure).	Baseline and at four-hours for each subject

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Suzanne Langley, OT, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2022
• Primary Completion (Actual): November 14, 2023
• Study Completion (Actual): November 14, 2023

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 10, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 5, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Asthenia
• Other Study ID Numbers: 21-009068

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes