Compression Therapy for Arm Weakness

No longer recruiting at 2 trial locations

Overseen By C. Joseph Yelvington, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Aphasia, DVT, CHF, acute kidney injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of using a special compression sleeve on the arm for individuals with arm weakness after a stroke. Typically used on legs, the sleeve will be applied to the arm for up to four hours to assess its benefits and safety. Suitable participants include those treated at Mayo Clinic/Jacksonville, who have arm weakness from a stroke, and can provide consent to participate.

As an unphased trial, this study allows participants to contribute to innovative research that could enhance stroke recovery therapies.

Do I need to stop taking my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients who have received thrombolytic therapeutic medicine more than 13 hours ago can participate, suggesting that some medications might be allowed.

What prior data suggests that this Sequential Compression Device is safe for arm weakness?

Research has shown that using a Sequential Compression Device (SCD) on the upper arm is generally safe. In earlier studies, patients with arm weakness from a stroke used this device without serious problems. Some common side effects include mild skin irritation or itching, but these are rare and not serious. Overall, the SCD is well-tolerated, making it a safe choice for those considering participation in a trial with this treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the Sequential Compression Device (SCD) for arm weakness in stroke patients because it offers a non-invasive and novel approach to rehabilitation. Unlike traditional methods like physical therapy or medication, the SCD uses a mechanical sleeve that applies pressure to the arm, potentially enhancing blood flow and muscle activity. This method could provide a quick, one-day intervention that may lead to improved arm function, offering a distinct advantage in terms of convenience and immediacy over more prolonged treatment options.

What evidence suggests that the Sequential Compression Device is effective for arm weakness?

Research shows that using a Sequential Compression Device (SCD) on the upper arm can help with weakness after a stroke. In this trial, participants will receive this compression therapy, which studies have found to improve both sensation and movement. The therapy uses a sleeve that gently squeezes the arm, potentially enhancing blood flow and reducing swelling. Early results are promising, suggesting this method could aid recovery in stroke survivors with arm difficulties. ^{1 2 3 5 6}

Who Is on the Research Team?

Suzanne Langley, OT

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I was admitted to Mayo Clinic/Jacksonville for a stroke and have weakness in one arm.

Patients who score > 13 on the BIMS to ensure intact cognition

I took clot-dissolving medicine more than 13 hours ago.

Exclusion Criteria

I've had surgery to remove lymph nodes under my arm and have heart failure or sudden swelling in my arm without known cause.

Subjects who are hemodynamically unstable

I am unable to give consent for participation on my own.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Application of Sequential Compression Device (SCD) and lower extremity sleeve on the upper extremity for up to 4 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lower Extremity Sleeve and Pump Device

Trial Overview 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.

How Is the Trial Designed?

Group I: Sequential Compression Device (SCD) on upper extremity Experimental Treatment 1 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

Lower Extremity Sleeve and Pump Device is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sequential Compression Device (SCD) for:

• Prevention of Deep Vein Thrombosis (DVT)
• Treatment of Lymphedema
• Management of Chronic Venous Insufficiency (CVI)

Approved in European Union as Sequential Compression Device (SCD) for:

• Prevention of Deep Vein Thrombosis (DVT)
• Treatment of Lymphedema
• Management of Chronic Venous Insufficiency (CVI)

Approved in Canada as Sequential Compression Device (SCD) for:

• Prevention of Deep Vein Thrombosis (DVT)
• Treatment of Lymphedema
• Management of Chronic Venous Insufficiency (CVI)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Venous ulcers, often caused by calf pump failure, can be effectively treated with adequate compression and occlusive dressings, especially for smaller lesions.

For larger and chronic wounds, external compression is beneficial, and long-term use of compression devices may be necessary to prevent recurrence of ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Venous ulcers: pathophysiology and medical therapy. Mulder, GD., Reis, TM.[2005]

The sequential compression device (SCD Express Compression System) was found to be more effective than the rapid inflation device (VenaFlow) in increasing venous blood flow, expelling significantly more blood per hour (9685 mL vs 4853 mL).

Although the rapid inflation device produced a higher peak flow velocity initially, it did not maintain this enhancement over time, while the sequential device provided consistent flow augmentation due to its longer compression cycles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of two intermittent pneumatic compression systems. A hemodynamic study. Kakkos, SK., Nicolaides, AN., Griffin, M., et al.[2016]

In a study involving 36 patients with arm lymphedema after breast cancer treatment, the advanced pneumatic compression device (APCD) led to a significant 29% reduction in arm edema, while the standard device (SPCD) resulted in a 16% increase in edema over 12 weeks.

The APCD also showed a 5.8% reduction in tissue water, indicating better efficacy in managing lymphedema compared to the SPCD, which had a 1.9% increase in tissue water.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Fife, CE., Davey, S., Maus, EA., et al.[2021]

Compression therapy is effective in treating conditions like venous stasis and lymphedema by reducing limb swelling through methods such as limb elevation, compression pumps, and wraps.

Regular follow-up during maintenance therapy is crucial to ensure optimal treatment and to adjust care as needed, especially for patients with severe lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression therapy for chronic venous insufficiency. Felty, CL., Rooke, TW.[2019]

A new compression device for lymphedema treatment was tested on 25 patients, showing significant reductions in limb size, with a 45% decrease at the wrist for upper extremities and a 47% decrease at the mid-calf for lower extremities after 24 hours of use.

The treatment was effective and safe, as it reduced limb volume by 45% without causing any increase in serum muscle enzyme levels, indicating no muscle damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential pneumatic compression for lymphedema. A controlled trial. Richmand, DM., O'Donnell, TF., Zelikovski, A.[2019]

Compression therapy has a long history of over 2,500 years and is designed to prevent swelling (edema) in the lower legs by enhancing the calf muscles' ability to push blood upward toward the heart.

The therapy can also help stabilize fresh blood clots in the calf veins, reducing the risk of serious complications like pulmonary embolism, but it is important to be aware of potential complications, including allergic skin reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compression therapy of vein and lymph vessel diseases of the lower extremities: a present day overview. Orbach, EJ.[2017]

A new pneumatic ambulatory compression device has been developed to treat lower limb edema by providing intermittent compression while allowing patients to remain mobile during walking.

In volunteer studies, the device effectively generated pressure changes of 20 to 50 mmHg on the lower calf, indicating its potential efficacy in managing edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new device producing ambulatory intermittent pneumatic compression suitable for the treatment of lower limb oedema: a preliminary report. Hamzeh, MA., Lonsdale, RJ., Pratt, DJ., et al.[2019]

In a study of 150 surgical patients, overall compliance with sequential compression devices (SCDs) and venous foot pumps (VFPs) was found to be 73%, with ICU patients showing significantly higher compliance (82%) compared to non-ICU patients (62%).

Factors that improved compliance included being admitted to the ICU and using SCDs instead of VFPs, suggesting that targeted strategies may be needed to enhance compliance in non-ICU patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical prophylaxis to prevent venous thromboembolism in surgical patients: a prospective trial evaluating compliance. Bockheim, HM., McAllen, KJ., Baker, R., et al.[2009]

The study measured the pressures delivered by two compression devices, Lympha Press (LP) and Flexitouch (FT), in 10 healthy adults, revealing that the LP produced significantly higher pressures than the FT.

The pressure patterns differed, with the FT showing a rapid rise and fall from wrist to elbow, while the LP maintained a higher, sustained pressure, indicating that device choice should be tailored to individual patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interface pressures produced by two different types of lymphedema therapy devices. Mayrovitz, HN.[2009]

Citations

1. withpower.com withpower.com/trial/compression-therapy-for-arm-weakness-16eaf

Compression Therapy for Arm Weakness Trial Overview 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506192/

Effects of compression therapy on the upper limb of patients ... This review will synthesise the body of evidence on the effectiveness of compression therapy in managing poststroke upper limb dysfunction.

3. trial.medpath.com trial.medpath.com/clinical-trial/66162975cde68846/pilot-study-lower-extremity-sleeve-compression-pump-device

A Study to Evaluate Lower Extremity Sleeve and Pump Device ... Studies has shown that passively stimulating the arm with vibration can improve sensory and motor recovery and movement. Researchers want to expand on this ...

4. researchgate.net researchgate.net/publication/396349084_Effects_of_compression_therapy_on_the_upper_limb_of_patients_with_stroke_a_systematic_review_protocol

(PDF) Effects of compression therapy on the upper limb ... This review will synthesise the body of evidence on the effectiveness of compression therapy in managing poststroke upper limb dysfunction.

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/57/NCT05535257/Prot_000.pdf

IRB Working Protocol Template To establish that an SCD and lower extremity (LE) sleeve can be used on a weak or reduced sensation upper extremity post stroke. Aim 2: Utilize ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7383414/

Risks and contraindications of medical compression treatment This paper reviews common risks and complications of compression therapy reported in literature (Table 1), including skin irritation and pruritus, rare ...