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

Not Applicable

Completed

• Conditions: Stroke; Upper Extremity Weakness
• Interventions: Device: Sequential Compression Device

• Registration Number: NCT05535257
• Lead Sponsor: Mayo Clinic

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-09-08
• Study First Posted: 2022-09-10
• Study Start: 2022-09-27
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Results First Submitted: 2024-11-05
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-05
• Last Update Submitted: 2025-01-05
• Results First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sequential Compression Device (SCD) on upper extremity	Sequential Compression Device	Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only

Primary Outcome Measures

Name	Time	Method
Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.	4 hours	Number of subjects who answered yes to the question "Are you tolerating this sleeve"

Secondary Outcome Measures

Name	Time	Method
Pain With SCD Sleeve and Device	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".

Trial Locations

Locations (1)

C Joseph Yelvington; 🇺🇸 Saint Johns, Florida, United States