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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535257
• Other study ID #: 21-009068
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: C. Joseph Yelvington, DPT
• Phone: 850-206-4596
• Email: Yelvington.C[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients admitted to Mayo Clinic/Jacksonville, post-stroke with a hemiparetic upper extremity.
• Able to provide consent of participation by self-agreement.
• Patients with a hemiparetic upper extremity will be determined using the NIH Motor Arm subsection from the NIH scale and score a 1-4.
• Patients who have received thrombolytic therapeutic medicine > 13 hours (per site specific policy) will not be excluded from inclusion in this study.
• Patients who score > 13 on the BIMS to ensure intact cognition.

Exclusion Criteria:

• Inability to provide consent of participation.
• Subjects with aphasia or the inability to effectively communicate their pain consistently.
• Questionable reliability scoring < 13 on the BIMS, has an existing invasive line (PICC line, IV, AV fistula or AV graft); recent surgery or vein ligation in the involved extremity.
• Recent skin graft in the involved extremity.
• Confirmed DVT in the affected.
• Upper extremity including axillary or subclavian veins; open or active wounds or infection in the involved extremity.
• Upper extremity ischemia, gangrene, cellulitis or severe arteriosclerosis in the affected upper extremity.
• Status-post axillary lymph node dissection on the involved side; congestive heart failure (CHF) acute exacerbation; acute edema of unknown etiology in the involved upper extremity.
• Subjects with extreme deformity of the affected upper extremity.
• Subjects with an acute kidney injury.
• Subjects who are hemodynamically unstable 1,7,17.
• Patients who have received thrombolytic therapeutic medicine administered < 13 hours (per site specific policy) prior to application of SCD sleeve.

Related Conditions & MeSH terms

• Asthenia
• Stroke
• Upper Extremity Weakness

Intervention

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.

Locations

Country	Name	City	State
United States	C Joseph Yelvington	Saint Johns	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Edema measured in inches of circumference of forearm	Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.	4 hours
Other	Nail bed Color	Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color	4 hours
Other	UE Strength using Motor Arm subsection #5 of NIH scale	The limb is placed in the appropriate position: extend the arm (palm down) 90 degrees if sitting or 45 degrees if supine. Drift is scored if the arm falls before 10 seconds. Documenting using Scale definition: 0=No drift, 1=Drift, 2=Some effort against gravity, 3=No effort against gravity; limb falls, 4=No movement	4 hours
Other	UE sensation	Using cotton swab and lightly touching skin at dermatome points C2, C3, C4, C5, C6, C7, C8, T1, T2 using the International Standards for the Classification of Spinal Cord Injury Key Sensory Points documenting "Intact" or "Impaired"	4 hours
Other	UE skin integrity	Prior to placement of sleeve and upon removal of sleeve during check time skin will be visually assessed and the terms "Intact" or "Impaired" will be documented. Any new "redness", "rash", or "bruising" and "area" of arm will be documented and the need to remove sleeve at that time will be determined.	4 hours
Primary	Wearing tolerance of the SCD and sleeve on the upper extremity.	Number of subjects out of 20 participants able to wear the SCD on the weak upper extremity for the complete duration of study participation will be determined based off patient self reporting from question "Are you tolerating this sleeve" Yes (Y) or No (N). 20 patients are to be included in this study, with goal of 0 participants with adverse affects of any grade as of result of wearing the sleeve. Patients that report No (N) to tolerance of the sleeve question above will be excluded at time of reporting and sleeve removed.	4 hours
Secondary	Pain with SCD sleeve and device	Pain values measured by Visual Analogue Scale (VAS) where patient identifies pain on a a line between "no pain" and "worst possible pain".	4 hours

External Links

•   Mayo Clinic Clinical Trials