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Completed

NCT Number: NCT05535257

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

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.

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Key information

Conditions

Upper Extremity Weakness Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

C Joseph Yelvington

Saint Johns, Florida, 32259, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for 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.

Treatment and study plan

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.

Other names: SCD

Primary outcomes

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

    Time frame: 4 hours

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

Secondary outcomes

  1. Pain With SCD Sleeve and Device

    Time frame: 4 hours

    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".

Other outcomes

  1. Nail Bed Color

    Time frame: 4 hours

    Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color

  2. Edema Measured in Inches of Circumference of Forearm

    Time frame: 4 hours

    Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.

  3. UE Strength Using Motor Arm Subsection #5 of NIH Scale

    Time frame: 4 hours

    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. UE Sensation

    Time frame: 4 hours

    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"

  5. UE Skin Integrity

    Time frame: 4 hours

    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.

  6. UE Grip Strength

    Time frame: Baseline and at four-hours for each subject

    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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Pilot Study to Establish Use of Lower Extremity Sleeve and Sequential Compression Pump Device in Patients With Upper Extremity Weakness Post-Stroke

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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