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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
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 moreAwards & 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
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.
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.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,332 Previous Clinical Trials
3,059,891 Total Patients Enrolled
24 Trials studying Stroke
10,959 Patients Enrolled for Stroke
Suzanne Langley, OTPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was admitted to Mayo Clinic/Jacksonville for a stroke and have weakness in one arm.I've had surgery to remove lymph nodes under my arm and have heart failure or sudden swelling in my arm without known cause.I am unable to give consent for participation on my own.I have a low reliability score and have an invasive line or recent surgery on my arm or leg.My arm is severely deformed.I received clot-dissolving medication less than 13 hours before using a compression device.I took clot-dissolving medicine more than 13 hours ago.I have a blood clot in my arm and no open wounds or infections there.I have partial paralysis in one arm, scoring 1-4 on a specific test.I have severe blood flow problems or infection in my arm.I currently have an acute kidney injury.I cannot effectively communicate my pain due to a condition.I recently had a skin graft on my limb.
Research Study Groups:
This trial has the following groups:- Group 1: Sequential Compression Device (SCD) on upper extremity
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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