Compression Therapy for Arm Weakness

Recruiting at2 trial locations

Overseen by Suzanne Langley, OT

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Compression Therapy for Arm Weakness is an effective treatment?

The available research shows that compression therapy can effectively reduce swelling in limbs affected by lymphedema. One study found that using a compression device led to a significant decrease in limb size, with a 45% reduction at the wrist for arm lymphedema. Another study compared two types of compression devices and found that an advanced device provided better outcomes in reducing arm swelling and tissue water content. These results suggest that compression therapy is a beneficial treatment for managing arm weakness due to lymphedema. ^{1 2 3 4 5}

What safety data exists for compression therapy for arm weakness?

The safety data for compression therapy, including devices like Sequential Compression Devices (SCDs) and Pneumatic Compression Devices, indicates that these treatments are generally safe. A study on a new compression device for lymphedema showed significant reduction in limb size without adverse effects, such as elevated serum muscle enzyme levels, even with high pressures. Another study confirmed the safe use of these devices in reducing lymphedema in both upper and lower extremities. Additionally, these devices are used safely in home settings for lymphedema management after breast cancer treatment. ^{1 3 4 6 7}

Is the Lower Extremity Sleeve and Pump Device a promising treatment for arm weakness?

Yes, the Lower Extremity Sleeve and Pump Device is a promising treatment. It helps reduce swelling in limbs by using a special pattern of pressure, which can quickly and safely decrease the size of swollen areas. This makes it easier for people to manage their condition at home and stay active. ^{1 3 4 8 9}

Research Team

Suzanne Langley, OT

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Treatment Details

Interventions

• Lower Extremity Sleeve and Pump Device (Compression 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.

Participant Groups

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 Canada for the following indications:

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+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Findings from Research

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]

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]

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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sequential pneumatic compression for lymphedema. A controlled trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Venous ulcers: pathophysiology and medical therapy. [2005]

3. Germany pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Italy pubmed.ncbi.nlm.nih.gov

Comparison of two intermittent pneumatic compression systems. A hemodynamic study. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Mechanical prophylaxis to prevent venous thromboembolism in surgical patients: a prospective trial evaluating compliance. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

Compression therapy for chronic venous insufficiency. [2019]

9. England pubmed.ncbi.nlm.nih.gov

A new device producing ambulatory intermittent pneumatic compression suitable for the treatment of lower limb oedema: a preliminary report. [2019]