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

Primary Purpose

Upper Extremity Weakness, Stroke

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Sequential Compression Device

About this trial

This is an interventional health services research trial for Upper Extremity Weakness

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

C Joseph YelvingtonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sequential Compression Device (SCD) on upper extremity

Arm Description

Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".

Full Information

NCT ID

NCT05535257

First Posted

August 19, 2022

Last Updated

October 5, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05535257

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 26, 2022 (Actual)

Primary Completion Date

August 2024 (Anticipated)

Study Completion Date

August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Extremity Weakness, Stroke

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sequential Compression Device (SCD) on upper extremity

Arm Type

Experimental

Arm Description

Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only

Intervention Type

Device

Intervention Name(s)

Sequential Compression Device

Other Intervention Name(s)

SCD

Intervention Description

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.

Primary Outcome Measure Information:

Title

Wearing tolerance of the SCD and sleeve on the upper extremity.

Description

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

Pain with SCD sleeve and device

Description

Pain values measured by Visual Analogue Scale (VAS) where patient identifies pain on a a line between "no pain" and "worst possible pain".

Time Frame

4 hours

Other Pre-specified Outcome Measures:

Title

Edema measured in inches of circumference of forearm

Description

Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.

Time Frame

4 hours

Title

Nail bed Color

Description

Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color

Time Frame

4 hours

Title

UE Strength using Motor Arm subsection #5 of NIH scale

Description

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

Time Frame

4 hours

Title

UE sensation

Description

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"

Time Frame

4 hours

Title

UE skin integrity

Description

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.

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

C. Joseph Yelvington, DPT

Phone

850-206-4596

Yelvington.C@mayo.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne Langley, OT

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

C Joseph Yelvington

City

Saint Johns

State/Province

Florida

ZIP/Postal Code

32259

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

C Joseph Yelvington, DPT

Phone

850-206-4596

yelvington.c@mayo.edu

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.mayo.edu/research/clinical-trials

Description

Mayo Clinic Clinical Trials

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

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