What side effects are associated with this type of intervention?

Sequential Compression Devices (SCDs) are generally safe and well-tolerated, but they can have some side effects. Common side effects include discomfort or pain at the site of application, skin irritation, and, in rare cases, pressure ulcers. Other common stroke treatments, such as anticoagulants, can lead to bleeding complications, while thrombolytics may cause hemorrhagic transformation of the stroke. It is important to discuss these potential side effects with a healthcare provider to ensure the benefits outweigh the risks.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke that focus on improving blood flow and preventing blood clots. Mechanical thrombectomy, which involves the use of stent retrievers and aspiration devices to remove clots from blocked arteries in the brain, is a key treatment. This method has been shown to be effective and safe for acute ischemic stroke. Additionally, anticoagulant and antiplatelet medications, such as tissue plasminogen activator (tPA), are commonly used to dissolve clots and improve blood flow. While Sequential Compression Devices (SCDs) are primarily used to prevent deep vein thrombosis (DVT) and improve circulation in the lower extremities, their application in stroke treatment is still under investigation.

What other types of research exist?

Promising alternatives to Sequential Compression Devices for stroke patients in 2024 include: 1) Intermittent Pneumatic Compression (IPC) devices, which have shown efficacy in various conditions including lymphedema and post-surgical thromboprophylaxis. 2) Advanced pharmacological agents like cilostazol and naftidrofuryl, which improve blood flow and have been effective in treating intermittent claudication. 3) Emerging technologies such as diaphragm pacing and electrical neuromodulation, which may offer novel ways to enhance circulation and prevent clot formation in stroke patients.

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Compression Device

Compression Therapy for Arm Weakness

N/A

Recruiting

Led By Suzanne Langley, OT

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device that wraps around the leg and uses gentle pressure to help blood flow. It aims to help patients with partial paralysis on one side of their body by improving movement and sensation in their affected arm, while also reducing the risk of blood clots.

Who is the study for?

This trial is for post-stroke patients at Mayo Clinic/Jacksonville with weakness in one arm, who can agree to participate and have a certain level of motor function. They must be able to communicate pain and not have conditions like recent surgery, active wounds, or severe blood vessel problems in the affected arm.

What is being tested?

The study tests if using a Sequential Compression Device (SCD) with a sleeve on the weak arm of stroke survivors is safe. It's applied to those whose upper extremity has been weakened due to stroke.

What are the potential side effects?

While specific side effects are not listed, the device may cause discomfort or potential issues in the treated limb such as swelling or skin irritation based on similar devices' profiles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Wearing tolerance of the SCD and sleeve on the upper extremity.

Secondary study objectives

Medical Devices

Other study objectives

Edema measured in inches of circumference of forearm

Nail bed Color

UE Strength using Motor Arm subsection #5 of NIH scale

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sequential Compression Device (SCD) on upper extremityExperimental Treatment1 Intervention

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

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for stroke aim to restore blood flow to the brain and prevent further clot formation. Mechanical thrombectomy involves the physical removal of a blood clot from a blocked artery using stent retrievers or aspiration devices, which can significantly improve outcomes if performed promptly. Anticoagulant therapy, such as the use of heparin or warfarin, helps to prevent new clots from forming and existing clots from growing, reducing the risk of recurrent strokes. Sequential Compression Devices (SCDs) and similar compression therapies improve blood flow and prevent clot formation by applying intermittent pressure to the limbs, which is particularly useful for patients with limited mobility. These treatments are crucial for stroke patients as they help to minimize brain damage, improve recovery outcomes, and reduce the risk of complications such as deep vein thrombosis.

Intra-arterial mechanical thrombectomy stent retrievers and aspiration devices in the treatment of acute ischaemic stroke: A systematic review and meta-analysis with trial sequential analysis.