Acute Ischemic Stroke, Intracerebral Hemorrhage
Conditions
Keywords
rehabilitation, cycle ergometry
Brief summary
This study aims to determine whether in-bed cycle ergometry, early in the hospital course after a brain hemorrhage could balance damaging and reparative inflammation in the brain. Inflammatory factors of two groups of patients with brain hemorrhage will be compared, one group will receive in-bed cycling beginning 3 days after hemorrhage plus usual care and the other group will receive usual care only.
Interventions
DEVICESupine cycle ergometry of the lower extremities
The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The clinician assessing outcomes will not have been involved in the care of the patient and will not be aware of the group assignment.
Intervention model description
Pilot randomized parallel group design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Supratentorial intracerebral hemorrhage with or without intraventricular hemorrhage * Pre-morbid modified Rankin Score of 0-2 * Patient must be able to provide informed consent or have a legally authorized representative to provide consent on patient's behalf
Exclusion criteria
* Patients with known inflammatory conditions, infection requiring antibiotics or pregnancy * Patients receiving daily anti-inflammatory medications including but not limited to prednisone, methotrexate, non-steroidal anti-inflammatory medications (ibuprofen, naproxen, indomethacin, celecoxib) and aspirin \>325mg * Glasgow Coma Score (GCS) 3 48 hours after admission * Patients in whom withdrawal of life support is being considered by surrogate decision makers * Injury to the lower extremities, hips or pelvis, weight \>250 kg (weight limit of cycle), or body habitus precluding normal function of cycle
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Salivary Cortisol Level (Microgram/Deciliter) | Day 1, day 3 and day 7 of study | — |
| Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | — |
| Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | — |
| Change in C Reactive Protein Level in Blood (Nanogram/Milliliter) | Day 1, day 3 and day 7 of study | — |
| Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | — |
| Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care. |
| Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | CSF will be collected only in patients with an external ventricular drain as part of patients' care. |
| Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | CSF will be collected only in patients with an external ventricular drain as part of patients' care. TNF-alpha normal range (1.45 pg/mL to 1073.41 pg/mL) |
| Change in C Reactive Protein Level in CSF (Nanogram/Milliliter) | Day 1, day 3 and day 7 of study | CSF will be collected only in patients with an external ventricular drain as part of patients' care |
| Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | CSF will be collected only in patients with an external ventricular drain as part of patients' care |
| Change in Interleukin-1beta Level in Blood (Picogram/Milliliter) | Day 1, day 3 and day 7 of study | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2 | Day 1 of study | The global physical health status subscale of the Promis scale v1.2 will be used to measure pre-morbid physical health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. 10 points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population. |
| Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2 | Day 1 of study | The global mental health status subscale of the Promis scale will be used to measure pre-morbid mental health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. Ten points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population. |
| Functional Status as Assessed by the Modified Rankin Score (mRS) | Standard of care 90-day assessment | The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Reporting the frequency of each score category. |
| Change in the Functional Status as Assessed by the Modified Rankin Score | Day of ICU transfer or discharge, 90 day assessment | The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Change in functional status was calculated by subtracting the first score (discharge) from the second score (90 day assessment). |
| Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score | Study days 1, 3, 7, On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit | The MRCS will be used to measure muscle strength over time. The instrument is a 60 point scale indicating muscle strength in 6 muscle groups. Three muscle groups each on the right and left upper extremities and three each in the right and left lower extremities. Each muscle group is scored from 0-5 out of a possible 5 points. A composite score with a maximum of 60 is produced, 30 points can be achieved for each side of the body. |
| Ability to Perform Activities of Daily Living as Assessed by the Barthel Index | On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit | The Barthel index will be used to measure a participant's ability to perform activities of daily living in detail. The instrument is a 10-item scale with a range of 0 -100 points. Higher scores indicate higher levels of function. |
| Health Status as Assessed by the Stroke Impact Scale Version 3.0 | During the 30-day follow up visit | This is a 59-item questionnaire that will measure health status in 8 domains following the stroke. A 5-point Likert scale is used to score each item with higher scores indicating higher perceived health status. |
| Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0 | During the 30-day follow up visit | The last question of the instrument measures a participant's perception of stroke recovery using a 0-100 scale with higher scores representing higher levels of recovery and lower scores representing less recovery. |
| Absolute Change in Hand-held Dynamometry Score (Pounds) | Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days | An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured. Grip strength is reported in pounds and compared against population and sex-based normative values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supine Cycle Ergometry of the Lower Extremities Patients will receive two 20 minute cycle ergometry sessions separated by at least 4 hours in addition to usual care. The cycle will be set to a gear of zero and will begin in passive mode, the patient will be able to actively cycle if patients are able.
Supine cycle ergometry of the lower extremities: The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor. | 14 |
| Control Patients will receive usual care only. | 11 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Participant safety | 1 | 0 |
| Overall Study | Withdrawn by family | 1 | 0 |
Baseline characteristics
| Characteristic | Supine Cycle Ergometry of the Lower Extremities | Control | Total |
|---|---|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 14.3 | 62.3 years STANDARD_DEVIATION 18.4 | 65.8 years STANDARD_DEVIATION 16.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 3 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 14 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 10 Participants |
| Sex: Female, Male Male | 9 Participants | 6 Participants | 15 Participants |
| Type of Stroke Acute Ischemic | 5 Participants | 4 Participants | 9 Participants |
| Type of Stroke Intracerebral Hemorrhage | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 14 | 3 / 11 |
| other Total, other adverse events | 2 / 14 | 0 / 11 |
| serious Total, serious adverse events | 0 / 14 | 0 / 11 |
Outcome results
Primary
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Population: Participants who were able to have samples drawn are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 1 | 8038.53 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 3 | 4380.57 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 7 | 3979.26 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 1 | 2554.34 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 3 | 3043.86 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter) | Day 7 | 2494.29 picograms/mL |
Primary
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time frame: Day 1, day 3 and day 7 of study
Population: 4 participants had an external ventricular drain and had CSF collected (2 intervention, 2 control)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | First participant in each arm, day 1 | 26.26 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | First participant in each arm, day 7 | 4.38 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 7 | 3.21 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 1 | 23.98 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | First participant in each arm, day 3 | 12.42 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 3 | 7.81 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | First participant in each arm, day 3 | 2.64 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 7 | 2.02 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | First participant in each arm, day 1 | 3.71 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 3 | 2.64 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | First participant in each arm, day 7 | 2.75 picograms/mL |
| Control | Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 1 | 2.02 picograms/mL |
Primary
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Population: One participant was withdrawn for safety reasons in the intervention arm. All timepoints collected are reported.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 1 | 7.01 picogram/milliliter |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 3 | 4.3 picogram/milliliter |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 7 | 2.94 picogram/milliliter |
| Control | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 1 | 6.18 picogram/milliliter |
| Control | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 3 | 4.59 picogram/milliliter |
| Control | Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter) | Day 7 | 3.17 picogram/milliliter |
Primary
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Time frame: Day 1, day 3 and day 7 of study
Population: 4 participants had an external ventricular drain and had CSF collected (2 intervention, 2 control)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | First participant in each arm, day 1 | 1659 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | First participant in each arm, day 3 | 3379.57 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | First participant in each arm, day 7 | 2729.16 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 1 | 268 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 3 | 495.57 picograms/mL |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 7 | 750.79 picograms/mL |
| Control | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 3 | 1040.6 picograms/mL |
| Control | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | First participant in each arm, day 1 | 158.79 picograms/mL |
| Control | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 1 | 454.64 picograms/mL |
| Control | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | First participant in each arm, day 3 | 386.02 picograms/mL |
| Control | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | Second participant in each arm, day 7 | 401.51 picograms/mL |
| Control | Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter) | First participant in each arm, day 7 | 19.2 picograms/mL |
Primary
Change in C Reactive Protein Level in Blood (Nanogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Population: C reactive protein was not performed due to lack of funding.
Primary
Change in C Reactive Protein Level in CSF (Nanogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Time frame: Day 1, day 3 and day 7 of study
Population: C Reactive Protein assay was not performed due to lack of funding.
Primary
Change in Interleukin-1beta Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Population: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Primary
Change in Interleukin-1beta Level in Cerebrospinal Fluid (Picogram/Milliliter)
Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
Time frame: Day 1, day 3 and day 7 of study
Population: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Primary
Change in Salivary Cortisol Level (Microgram/Deciliter)
Time frame: Day 1, day 3 and day 7 of study
Population: Samples not collected
Primary
Change in Tumor Necrosis Factor-alpha Level in Blood (Picogram/Milliliter)
Time frame: Day 1, day 3 and day 7 of study
Population: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Primary
Change in Tumor Necrosis Factor (TNF) -Alpha Level in CSF (Picogram/Milliliter)
CSF will be collected only in patients with an external ventricular drain as part of patients' care. TNF-alpha normal range (1.45 pg/mL to 1073.41 pg/mL)
Time frame: Day 1, day 3 and day 7 of study
Population: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Secondary
Ability to Perform Activities of Daily Living as Assessed by the Barthel Index
The Barthel index will be used to measure a participant's ability to perform activities of daily living in detail. The instrument is a 10-item scale with a range of 0 -100 points. Higher scores indicate higher levels of function.
Time frame: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit
Population: Due to resource constraints this assessment was only performed at discharge and only in 14 patients, 7 each in the intervention and control arms.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Ability to Perform Activities of Daily Living as Assessed by the Barthel Index | 10 score on a scale |
| Control | Ability to Perform Activities of Daily Living as Assessed by the Barthel Index | 5 score on a scale |
Secondary
Absolute Change in Hand-held Dynamometry Score (Pounds)
An average of three hand-held dynamometry measurements will be calculated for each measurement episode and the change over time will be measured. Grip strength is reported in pounds and compared against population and sex-based normative values.
Time frame: Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 days
Population: Six participants, 3 in each group had dynamometry values collected.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, day 3 | 19.87 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, day 7 | 60.07 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, discharge | 14.7 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, discharge | 48.33 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, day 1 | 28.8 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, day 1 | 41.6 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, day 3 | 92.9 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, day 7 | 21.2 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, day 7 | 79.4 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, day 3 | 40.87 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, discharge | 90.93 pounds |
| Supine Cycle Ergometry of the Lower Extremities | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, day 1 | 91.5 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, discharge | 70.6 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, day 1 | 25.7 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, day 3 | 24.55 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, day 7 | 33.6 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | First participant in each arm, discharge | 55.4 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, day 1 | 19.57 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, day 3 | 22.63 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, day 7 | 20.07 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Second participant in each arm, discharge | 10 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, day 1 | 70.97 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, day 3 | 87.53 pounds |
| Control | Absolute Change in Hand-held Dynamometry Score (Pounds) | Third participant in each arm, day 7 | 75.76 pounds |
Secondary
Change in Muscle Strength as Assessed by the Medical Research Council Sum (MRCS) Score
The MRCS will be used to measure muscle strength over time. The instrument is a 60 point scale indicating muscle strength in 6 muscle groups. Three muscle groups each on the right and left upper extremities and three each in the right and left lower extremities. Each muscle group is scored from 0-5 out of a possible 5 points. A composite score with a maximum of 60 is produced, 30 points can be achieved for each side of the body.
Time frame: Study days 1, 3, 7, On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visit
Population: Resource limitations precluded collection of this data.
Secondary
Change in the Functional Status as Assessed by the Modified Rankin Score
The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Change in functional status was calculated by subtracting the first score (discharge) from the second score (90 day assessment).
Time frame: Day of ICU transfer or discharge, 90 day assessment
Population: Only 4 patients had scores at discharge or transfer and at the 90 day assessment per standard of care (1 in the treatment group and 3 in the control group). Change in scores are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Change in the Functional Status as Assessed by the Modified Rankin Score | First participant, change in score | 0 score on a scale |
| Control | Change in the Functional Status as Assessed by the Modified Rankin Score | First participant, change in score | 2 score on a scale |
| Control | Change in the Functional Status as Assessed by the Modified Rankin Score | Second participant, change in score | -1 score on a scale |
| Control | Change in the Functional Status as Assessed by the Modified Rankin Score | Third participant, change in score | 2 score on a scale |
Secondary
Functional Status as Assessed by the Modified Rankin Score (mRS)
The modified Rankin score will be used to measure function in terms of activities of daily living after stroke. A six-point ordinal scale (0-6) with lower scores indicating less disability and higher scores indicating increasingly severe disability. A score of 6 indicates death. Reporting the frequency of each score category.
Time frame: Standard of care 90-day assessment
Population: 17 patients had the modified Rankin assessed per standard of care at 90 days.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 2 | 1 Participants |
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 4 | 1 Participants |
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 1 | 2 Participants |
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 5 | 2 Participants |
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 3 | 0 Participants |
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 6 | 1 Participants |
| Supine Cycle Ergometry of the Lower Extremities | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 0 | 0 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 6 | 3 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 0 | 0 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 1 | 0 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 2 | 3 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 3 | 1 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 4 | 1 Participants |
| Control | Functional Status as Assessed by the Modified Rankin Score (mRS) | mRS 5 | 2 Participants |
Secondary
Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2
The global mental health status subscale of the Promis scale will be used to measure pre-morbid mental health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. Ten points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population.
Time frame: Day 1 of study
Population: Participants who completed the survey are reported.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2 | 53.3 score on a scale |
| Control | Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2 | 41.15 score on a scale |
Secondary
Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2
The global physical health status subscale of the Promis scale v1.2 will be used to measure pre-morbid physical health status. A 5-point Likert scale is used to score each of the four items. The scores for each item are summed as a raw score and are converted to T scores using a standardized table with higher T scores indicating better physical health status. An average t score representing the population is 50. 10 points is equal to 1 standard deviation, thus a score of 60 means that one is one standard deviation better than the general population.
Time frame: Day 1 of study
Population: Participants who completed the survey are reported.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Supine Cycle Ergometry of the Lower Extremities | Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2 | 38.6 T-score |
| Control | Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2 | 44.9 T-score |
Secondary
Health Status as Assessed by the Stroke Impact Scale Version 3.0
This is a 59-item questionnaire that will measure health status in 8 domains following the stroke. A 5-point Likert scale is used to score each item with higher scores indicating higher perceived health status.
Time frame: During the 30-day follow up visit
Population: Resource constraints precluded collection of this data.
Secondary
Perception of Stroke Recovery as Assessed by the Stroke Impact Scale Version 3.0
The last question of the instrument measures a participant's perception of stroke recovery using a 0-100 scale with higher scores representing higher levels of recovery and lower scores representing less recovery.
Time frame: During the 30-day follow up visit
Population: Resource constraints precluded collection of this data.