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

NCT ID: NCT05535257

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-27
• Study Completion Date: 2023-11-14

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.

Conditions

Upper Extremity Weakness; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Sequential Compression Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SCD

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Suzanne K. Langley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Langley, OT

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

C Joseph Yelvington

Saint Johns, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

21-009068

Identifier Type: -

Identifier Source: org_study_id