Upper Extremity Weakness, Stroke
Conditions
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.
Interventions
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wearing Tolerance of the SCD and Sleeve on the Upper Extremity. | 4 hours | Number of subjects who answered yes to the question Are you tolerating this sleeve |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain With SCD Sleeve and Device | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| UE Strength Using Motor Arm Subsection #5 of NIH Scale | 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 |
| UE Sensation | 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 |
| Nail Bed Color | 4 hours | Nail bed color will be observed and described/documented with terms of normal, dusky, or bluish in color |
| UE Grip Strength | 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). |
| UE Skin Integrity | 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. |
| Edema Measured in Inches of Circumference of Forearm | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Sequential Compression Device (SCD) on Upper Extremity |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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
Time frame: 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | Wearing Tolerance of the SCD and Sleeve on the Upper Extremity. | 20 Participants |
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.
Time frame: 4 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | Pain With SCD Sleeve and Device | 20 Participants |
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.
Time frame: 4 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | 1.5 inch decrease in circumference | 2 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | 1.25 inch decrease in circumference | 2 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | 1 inch decrease in circumference | 2 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | .5 inch decrease in circumference | 1 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | .25 inch decrease in circumference | 6 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | No change in circumference | 3 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Edema Measured in Inches of Circumference of Forearm | .25 inch increase in circumference | 4 Participants |
Other Pre-specified
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | Nail Bed Color | Normal | 20 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Nail Bed Color | Bluish | 0 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | Nail Bed Color | Dusky | 0 Participants |
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).
Time frame: Baseline and at four-hours for each subject
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 0 lbs baseline and 0 at 4 hours | 5 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 30 lbs at baseline and 34 lbs at 4 hours | 1 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 12 lbs at baseline and 10 lbs at 4 hours | 1 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 65 lbs at baseline and 62 lbs at 4 hours | 1 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 35 lbs at baseline and 35 lbs at 4 hours | 1 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 20 lbs at baseline and 2 lbs at 4 hours | 1 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Grip Strength | 32 lbs at baseline and 38 lbs at 4 hours | 1 Participants |
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
Time frame: 4 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | UE Sensation | Sensation Intact | 10 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Sensation | Sensation Impaired | 10 Participants |
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.
Time frame: 4 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | UE Skin Integrity | Intact Skin Integrity | 20 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Skin Integrity | Impaired Skin Integrity | 0 Participants |
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
Time frame: 4 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Sequential Compression Device (SCD) on Upper Extremity | UE Strength Using Motor Arm Subsection #5 of NIH Scale | 4 (no movement) | 2 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Strength Using Motor Arm Subsection #5 of NIH Scale | 3 (no effort against gravity) | 3 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Strength Using Motor Arm Subsection #5 of NIH Scale | 2 (some effort against gravity) | 5 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Strength Using Motor Arm Subsection #5 of NIH Scale | 1 (drift) | 8 Participants |
| Sequential Compression Device (SCD) on Upper Extremity | UE Strength Using Motor Arm Subsection #5 of NIH Scale | 0 (no drift) | 2 Participants |