NCT05535257

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

Pilot Study to Establish Use of Lower Extremity Sleeve and Sequential Compression Pump Device in Patients With Upper Extremity Weakness Post-Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2022-09-27
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2022-09-10
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study