Trial Outcomes & Findings for A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis (NCT NCT05535257)

NCT ID: NCT05535257

Last Updated: 2025-01-09

Results Overview

Number of subjects who answered yes to the question "Are you tolerating this sleeve"

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 20 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2025-01-09

Participant Flow

Recruitment period for 20 subjects enrolled in this study was from 9/27/2022 to 11/14/2023. All subjects were recruited and enrolled in the Mayo Clinic Hospital setting.

Participant milestones

Measure	Sequential Compression Device (SCD) on Upper Extremity Subjects post stroke with upper extremity weakness and impaired sensation have the SCD sleeve placed on the arm for up to 4 hours for one day only 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.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Subjects post stroke with upper extremity weakness had the SCD sleeve placed on the arm for up to 4 hours for one day only Device: Sequential Compression Device Calf size lower extremity sequential compression device sleeve was placed on the weak upper extremity blow the cubital fossa and may include the hand if necessary. The device inflated and deflated, Other Names: SCD
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Number of subjects who answered yes to the question "Are you tolerating this sleeve"

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.	20 Participants

SECONDARY outcome

Timeframe: 4 hours

Total number of subjects to report No pain measured by Visual Analogue Scale (VAS) where patient identifies pain on a line between "no pain" and "worst possible pain".

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
Pain With SCD Sleeve and Device	20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours

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

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
Nail Bed Color Normal	20 Participants
Nail Bed Color Bluish	0 Participants
Nail Bed Color Dusky	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours

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

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
Edema Measured in Inches of Circumference of Forearm 1.5 inch decrease in circumference	2 Participants
Edema Measured in Inches of Circumference of Forearm 1.25 inch decrease in circumference	2 Participants
Edema Measured in Inches of Circumference of Forearm 1 inch decrease in circumference	2 Participants
Edema Measured in Inches of Circumference of Forearm .5 inch decrease in circumference	1 Participants
Edema Measured in Inches of Circumference of Forearm .25 inch decrease in circumference	6 Participants
Edema Measured in Inches of Circumference of Forearm No change in circumference	3 Participants
Edema Measured in Inches of Circumference of Forearm .25 inch increase in circumference	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours

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

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
UE Strength Using Motor Arm Subsection #5 of NIH Scale 4 (no movement)	2 Participants
UE Strength Using Motor Arm Subsection #5 of NIH Scale 3 (no effort against gravity)	3 Participants
UE Strength Using Motor Arm Subsection #5 of NIH Scale 2 (some effort against gravity)	5 Participants
UE Strength Using Motor Arm Subsection #5 of NIH Scale 1 (drift)	8 Participants
UE Strength Using Motor Arm Subsection #5 of NIH Scale 0 (no drift)	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours

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"

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
UE Sensation Sensation Intact	10 Participants
UE Sensation Sensation Impaired	10 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 hours

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.

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=20 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
UE Skin Integrity Intact Skin Integrity	20 Participants
UE Skin Integrity Impaired Skin Integrity	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and at four-hours for each subject

Using dynamometer in pounds measures affected hand strength at baseline and at 4-hours for each subject. This outcome measure was added approximately 1/2 way through the subject recruitment as a revision to this study to help capture subjects with hand weakness who may not have gross arm weakness (captured by Motor arm Subsection #5 outcome measure).

Outcome measures

Measure	Sequential Compression Device (SCD) on Upper Extremity n=11 Participants Wearing tolerance outcome measure results of 20 subjects based on 4 hour wearing trial
UE Grip Strength 0 lbs baseline and 0 at 4 hours	5 Participants
UE Grip Strength 30 lbs at baseline and 34 lbs at 4 hours	1 Participants
UE Grip Strength 12 lbs at baseline and 10 lbs at 4 hours	1 Participants
UE Grip Strength 65 lbs at baseline and 62 lbs at 4 hours	1 Participants
UE Grip Strength 35 lbs at baseline and 35 lbs at 4 hours	1 Participants
UE Grip Strength 20 lbs at baseline and 2 lbs at 4 hours	1 Participants
UE Grip Strength 32 lbs at baseline and 38 lbs at 4 hours	1 Participants

Adverse Events

Sequential Compression Device (SCD) on Upper Extremity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Suzanne Langley OTR/L

Mayo Clinic Florida

Phone: 9044724288

Email: langley.suzanne@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place