Clinical trial NCT05535257: 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
Overall status: COMPLETED
Phase: NA
Conditions: Upper Extremity Weakness
Stroke
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.
timeFrame: 4 hours
Secondary outcomes:
measure: Pain With SCD Sleeve and Device
timeFrame: 4 hours
Other outcomes:
measure: Nail Bed Color
timeFrame: 4 hours
measure: Edema Measured in Inches of Circumference of Forearm
timeFrame: 4 hours
measure: UE Strength Using Motor Arm Subsection #5 of NIH Scale
timeFrame: 4 hours
measure: UE Sensation
timeFrame: 4 hours
measure: UE Skin Integrity
timeFrame: 4 hours
measure: UE Grip Strength
timeFrame: Baseline and at four-hours for each subject
Locations:
city: Saint Johns
country: United States
facility: C Joseph Yelvington
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Suzanne Langley, OT
role: PRINCIPAL_INVESTIGATOR
References: