An interventional study of Sequential Compression Device in Upper Extremity Weakness and Stroke, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Health services research
Among 198 studies in Paresis with a site in United States — 33 open to participants now, 42 under way, none of them phase 3. Paresis · United States.
Among the 198 studies in Paresis with a site in United States, this one is the 115th largest by enrollment of the 191 interventional ones that give a count, is one of 10 that started in 2022, is one of 151 with no phase, and was the 164th registered.
468 studies on the registry are indexed under Paresis; 117 are open to participants now.
This study's enrollment of 20 is below the median of 37 across 420 interventional studies indexed under Paresis.
Browse Paresis studies →33 of the 198 studies in Paresis with a site in United States are open now, in 4 countries. Each count lists the studies.
Of the 83 Paresis studies recruiting now, 34 (41%) set no upper age limit and 27 (33%) stop at 75 or younger; 10 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
The full table on the hub →198 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 10 started in 2022.
Median enrollment 28 across the 191 interventional studies, 47 across the 7 observational. Of the 138 that completed or were terminated, 58 (42%) have results posted.
20 of 198 have an industry lead sponsor. The 10 most frequent:
Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Mayo Clinic has 2 studies filed under Paresis — fewer than ten, so there is no comparison to draw.
20 of the studies in Paresis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05492513University of Alabama at BirminghamConstraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment | 2026-11 |
| NCT02896348Spaulding Rehabilitation HospitalAssessment of a Physio-neuro Platform (SynPhNe) for Home-based Retraining of Hand Function in Stroke Survivors | 2026-12 |
| NCT06541015University of Texas Southwestern Medical CenterEffect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients | 2026-12-31 |
| NCT05701280Enspire DBS Therapy, Inc.Pilot/Pivotal Study of DBS+Rehab After Stroke | 2027-01 |
| NCT04534556Baylor Research InstituteWireless Nerve Stimulation Device To Enhance Recovery After Stroke | 2027-01-01 |
Among the 198 studies in Paresis with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects post stroke with upper extremity weakness have 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 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.
Also known as: SCD
Wearing Tolerance of the SCD and Sleeve on the Upper Extremity.
Number of subjects who answered yes to the question "Are you tolerating this sleeve"
Time frame: 4 hours
Pain With SCD Sleeve and Device
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".
Time frame: 4 hours
Nail Bed Color
Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color
Time frame: 4 hours
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.
Time frame: 4 hours
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
Time frame: 4 hours
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"
Time frame: 4 hours
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.
Time frame: 4 hours
UE Grip Strength
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).
Time frame: Baseline and at four-hours for each subject
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.
| Milestone | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Number of subjects who answered yes to the question "Are you tolerating this sleeve"
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Wearing Tolerance of the SCD and Sleeve on the Upper Extremity. | 20 |
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".
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Pain With SCD Sleeve and Device | 20 |
Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Normal | 20 |
| Bluish | 0 |
| Dusky | 0 |
Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| 1.5 inch decrease in circumference | 2 |
| 1.25 inch decrease in circumference | 2 |
| 1 inch decrease in circumference | 2 |
| .5 inch decrease in circumference | 1 |
| .25 inch decrease in circumference | 6 |
| No change in circumference | 3 |
| .25 inch increase in circumference | 4 |
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
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| 4 (no movement) | 2 |
| 3 (no effort against gravity) | 3 |
| 2 (some effort against gravity) | 5 |
| 1 (drift) | 8 |
| 0 (no drift) | 2 |
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"
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Sensation Intact | 10 |
| Sensation Impaired | 10 |
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.
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Intact Skin Integrity | 20 |
| Impaired Skin Integrity | 0 |
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).
| Participants | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| 0 lbs baseline and 0 at 4 hours | 5 |
| 30 lbs at baseline and 34 lbs at 4 hours | 1 |
| 12 lbs at baseline and 10 lbs at 4 hours | 1 |
| 65 lbs at baseline and 62 lbs at 4 hours | 1 |
| 35 lbs at baseline and 35 lbs at 4 hours | 1 |
| 20 lbs at baseline and 2 lbs at 4 hours | 1 |
| 32 lbs at baseline and 38 lbs at 4 hours | 1 |
Collected over Adverse Event data was collected during the wearing trial (4 hours) of each subjects participation from dates 9/27/2022 to 11/14/2023. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 10 |
| >=65 years | 10 |
| Sex: Female, Male(Participants) | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Female | 7 |
| Male | 13 |
| Race (NIH/OMB)(Participants) | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| United States | 20 |
Plan to share: No
Ran from Sep 2022 to primary completion in Nov 2023, 13 months.
Results were first posted in Jan 2025, 1 year 1 month after primary completion.
Of 221 non-industry interventional studies with no phase under Paresis, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 55. This study's 13 months is below that.
Counting every sponsor, half of 239 studies reached it within 32 months; a quarter within 13 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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