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A Study to Evaluate Lower Extremity Sleeve and Pump Device to Treat Hemiparesis
NA trial testing Sequential Compression Device in Upper Extremity Weakness in 20 participants. Completed in 14 November 2023.
| Lead sponsor | Mayo Clinic |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 20 |
| Start date | 27 September 2022 |
| Primary completion | 14 November 2023 |
| Estimated completion | 14 November 2023 |
| Sites | 1 location across United States |
Mayo Clinic
Adults 18 to 100, any sex, with Upper Extremity Weakness or Stroke. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of subjects who answered yes to the question "Are you tolerating this sleeve"
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on 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".
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 20 |
Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 20 | |
| Sequential Compression Device (SCD) on Upper Extremity | 0 | |
| Sequential Compression Device (SCD) on Upper Extremity | 0 |
Using tape measure the weak UE forearm will be measured in inches; 5 inches distal to cubital fossa, proximal from the wrist crease.
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 6 |
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 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
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 2 | |
| Sequential Compression Device (SCD) on Upper Extremity | 3 | |
| Sequential Compression Device (SCD) on Upper Extremity | 5 | |
| Sequential Compression Device (SCD) on Upper Extremity | 8 |
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"
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 10 | |
| Sequential Compression Device (SCD) on Upper Extremity | 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.
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 20 | |
| Sequential Compression Device (SCD) on Upper Extremity | 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).
| Group | Value | 95% CI |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | 5 | |
| Sequential Compression Device (SCD) on Upper Extremity | 1 | |
| Sequential Compression Device (SCD) on Upper Extremity | 1 | |
| Sequential Compression Device (SCD) on Upper Extremity | 1 |
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.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05535257.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing