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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequential Compression Device (SCD) on upper extremity | Experimental | Subjects post stroke with upper extremity weakness have the SCD sleeve placed on the arm for up to 4 hours for one day only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sequential Compression Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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" | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Nail Bed Color | Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suzanne Langley, OT | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C Joseph Yelvington | Saint Johns | Florida | 32259 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequential Compression Device (SCD) on Upper Extremity | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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" | Posted | Count of Participants | Participants | 4 hours |
|
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Adverse Event data was collected during the wearing trial (4 hours) of each subjects participation from dates 9/27/2022 to 11/14/2023
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sequential Compression Device (SCD) on Upper Extremity | Stroke patients with UE weakness and or sensory impairments. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Suzanne Langley OTR/L | Mayo Clinic Florida | 9044724288 | langley.suzanne@mayo.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2022 | Oct 14, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010291 | Paresis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| 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 | 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" | 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. | 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). | Baseline and at four-hours for each subject |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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| Secondary | 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". | Posted | Count of Participants | Participants | 4 hours |
|
|
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| Other Pre-specified | Nail Bed Color | Nail bed color will be observed and described/documented with terms of "normal", "dusky", or "bluish" in color | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Other Pre-specified | 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 | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Other Pre-specified | 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" | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | 4 hours |
|
|
|
| Other Pre-specified | 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). | Posted | Count of Participants | Participants | Baseline and at four-hours for each subject |
|
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| .5 inch decrease in circumference |
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| .25 inch decrease in circumference |
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| No change in circumference |
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| .25 inch increase in circumference |
|
| 1 (drift) |
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| 0 (no drift) |
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| 65 lbs at baseline and 62 lbs at 4 hours |
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| 35 lbs at baseline and 35 lbs at 4 hours |
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| 20 lbs at baseline and 2 lbs at 4 hours |
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| 32 lbs at baseline and 38 lbs at 4 hours |
|