Trial Outcomes & Findings for Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage (NCT NCT04027049)
NCT ID: NCT04027049
Last Updated: 2024-05-01
Results Overview
COMPLETED
NA
25 participants
Day 1, day 3 and day 7 of study
2024-05-01
Participant Flow
Participant milestones
| Measure |
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.
|
Control
Patients will receive usual care only.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
11
|
|
Overall Study
COMPLETED
|
12
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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.
|
Control
Patients will receive usual care only.
|
|---|---|---|
|
Overall Study
Withdrawn by family
|
1
|
0
|
|
Overall Study
Participant safety
|
1
|
0
|
Baseline Characteristics
Biologic Mechanisms of Early Exercise After Intracerebral Hemorrhage
Baseline characteristics by cohort
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=14 Participants
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.
|
Control
n=11 Participants
Patients will receive usual care only.
|
Total
n=25 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
68.7 years
STANDARD_DEVIATION 14.3 • n=99 Participants
|
62.3 years
STANDARD_DEVIATION 18.4 • n=107 Participants
|
65.8 years
STANDARD_DEVIATION 16.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Type of Stroke
Acute Ischemic
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Type of Stroke
Intracerebral Hemorrhage
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: One participant was withdrawn for safety reasons in the intervention arm. All timepoints collected are reported.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=13 Participants
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.
|
Control
n=11 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Day 1
|
7.01 picogram/milliliter
Interval 1.89 to 10.51
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6.18 picogram/milliliter
Interval 2.27 to 15.68
|
|
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Day 3
|
4.3 picogram/milliliter
Interval 1.89 to 10.94
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4.59 picogram/milliliter
Interval 2.26 to 9.12
|
|
Absolute Change in Interleukin-6 Level in Blood (Picogram/Milliliter)
Day 7
|
2.94 picogram/milliliter
Interval 1.91 to 12.36
|
3.17 picogram/milliliter
Interval 0.88 to 4.29
|
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: C reactive protein was not performed due to lack of funding.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: Participants who were able to have samples drawn are reported.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=13 Participants
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.
|
Control
n=11 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Day 1
|
8038.53 picograms/mL
Interval 2980.91 to 11669.31
|
2554.34 picograms/mL
Interval 1945.37 to 4223.35
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Day 3
|
4380.57 picograms/mL
Interval 3706.41 to 7369.67
|
3043.86 picograms/mL
Interval 1204.4 to 4536.79
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in Blood (Picogram/Milliliter)
Day 7
|
3979.26 picograms/mL
Interval 2274.52 to 6745.13
|
2494.29 picograms/mL
Interval 1012.11 to 2812.83
|
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
Cerebrospinal fluid (CSF) will be collected only in patients with an external ventricular drain as part of patients' care.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: 4 participants had an external ventricular drain and had CSF collected (2 intervention, 2 control)
CSF will be collected only in patients with an external ventricular drain as part of patients' care.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=2 Participants
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.
|
Control
n=2 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
First participant in each arm, day 1
|
1659 picograms/mL
|
158.79 picograms/mL
|
|
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
First participant in each arm, day 3
|
3379.57 picograms/mL
|
386.02 picograms/mL
|
|
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
First participant in each arm, day 7
|
2729.16 picograms/mL
|
19.2 picograms/mL
|
|
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
Second participant in each arm, day 1
|
268 picograms/mL
|
454.64 picograms/mL
|
|
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
Second participant in each arm, day 3
|
495.57 picograms/mL
|
1040.6 picograms/mL
|
|
Absolute Change in Interleukin-6 Level in CSF (Picogram/Milliliter)
Second participant in each arm, day 7
|
750.79 picograms/mL
|
401.51 picograms/mL
|
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: Samples collected did not meet the threshold for analysis, therefore this outcome measure could not be assessed.
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)
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: C Reactive Protein assay was not performed due to lack of funding.
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: 4 participants had an external ventricular drain and had CSF collected (2 intervention, 2 control)
CSF will be collected only in patients with an external ventricular drain as part of patients' care
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=2 Participants
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.
|
Control
n=2 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
First participant in each arm, day 1
|
26.26 picograms/mL
|
3.71 picograms/mL
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
First participant in each arm, day 3
|
12.42 picograms/mL
|
2.64 picograms/mL
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
First participant in each arm, day 7
|
4.38 picograms/mL
|
2.75 picograms/mL
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
Second participant in each arm, day 1
|
23.98 picograms/mL
|
2.02 picograms/mL
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
Second participant in each arm, day 3
|
7.81 picograms/mL
|
2.64 picograms/mL
|
|
Absolute Change in Brain Derived Neurotrophic Factor Level in CSF (Picogram/Milliliter)
Second participant in each arm, day 7
|
3.21 picograms/mL
|
2.02 picograms/mL
|
PRIMARY outcome
Timeframe: Day 1, day 3 and day 7 of studyPopulation: Samples not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Study days 1, 3, 7, day of transfer from the ICU or discharge, whichever comes first, assessed up to 60 daysPopulation: Six participants, 3 in each group had dynamometry values collected.
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.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=3 Participants
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.
|
Control
n=3 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Third participant in each arm, day 3
|
92.9 pounds
|
87.53 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
First participant in each arm, day 1
|
28.8 pounds
|
25.7 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
First participant in each arm, day 3
|
19.87 pounds
|
24.55 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
First participant in each arm, day 7
|
21.2 pounds
|
33.6 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
First participant in each arm, discharge
|
14.7 pounds
|
55.4 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Second participant in each arm, day 1
|
41.6 pounds
|
19.57 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Second participant in each arm, day 3
|
40.87 pounds
|
22.63 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Second participant in each arm, day 7
|
60.07 pounds
|
20.07 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Second participant in each arm, discharge
|
48.33 pounds
|
10 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Third participant in each arm, day 1
|
91.5 pounds
|
70.97 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Third participant in each arm, day 7
|
79.4 pounds
|
75.76 pounds
|
|
Absolute Change in Hand-held Dynamometry Score (Pounds)
Third participant in each arm, discharge
|
90.93 pounds
|
70.6 pounds
|
SECONDARY outcome
Timeframe: Day 1 of studyPopulation: Participants who completed the survey are reported.
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.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=6 Participants
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.
|
Control
n=5 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Global Pre-morbid Physical Health Status as Measured by the Promis Scale v1.2
|
38.6 T-score
Interval 37.4 to 43.63
|
44.9 T-score
Interval 37.4 to 57.7
|
SECONDARY outcome
Timeframe: Day 1 of studyPopulation: Participants who completed the survey are reported.
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.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=6 Participants
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.
|
Control
n=6 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Global Pre-morbid Mental Health Status as Measured by the Promis Scale v1.2
|
53.3 score on a scale
Interval 45.95 to 53.3
|
41.15 score on a scale
Interval 35.05 to 47.1
|
SECONDARY outcome
Timeframe: Standard of care 90-day assessmentPopulation: 17 patients had the modified Rankin assessed per standard of care at 90 days.
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.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=7 Participants
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.
|
Control
n=10 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 0
|
0 Participants
|
0 Participants
|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 1
|
2 Participants
|
0 Participants
|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 2
|
1 Participants
|
3 Participants
|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 3
|
0 Participants
|
1 Participants
|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 4
|
1 Participants
|
1 Participants
|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 5
|
2 Participants
|
2 Participants
|
|
Functional Status as Assessed by the Modified Rankin Score (mRS)
mRS 6
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day of ICU transfer or discharge, 90 day assessmentPopulation: 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.
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).
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=1 Participants
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.
|
Control
n=3 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Change in the Functional Status as Assessed by the Modified Rankin Score
First participant, change in score
|
0 score on a scale
|
2 score on a scale
|
|
Change in the Functional Status as Assessed by the Modified Rankin Score
Second participant, change in score
|
—
|
-1 score on a scale
|
|
Change in the Functional Status as Assessed by the Modified Rankin Score
Third participant, change in score
|
—
|
2 score on a scale
|
SECONDARY outcome
Timeframe: 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 visitPopulation: Resource limitations precluded collection of this data.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: On transfer from the ICU or discharge from the hospital, whichever comes first, assessed up to 60 days, 30-day follow-up visitPopulation: Due to resource constraints this assessment was only performed at discharge and only in 14 patients, 7 each in the intervention and control arms.
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.
Outcome measures
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=7 Participants
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.
|
Control
n=7 Participants
Patients will receive usual care only.
|
|---|---|---|
|
Ability to Perform Activities of Daily Living as Assessed by the Barthel Index
|
10 score on a scale
Interval 2.5 to 25.0
|
5 score on a scale
Interval 2.5 to 22.5
|
SECONDARY outcome
Timeframe: During the 30-day follow up visitPopulation: Resource constraints precluded collection of this data.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During the 30-day follow up visitPopulation: Resource constraints precluded collection of this data.
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.
Outcome measures
Outcome data not reported
Adverse Events
Supine Cycle Ergometry of the Lower Extremities
Control
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Supine Cycle Ergometry of the Lower Extremities
n=14 participants at risk
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.
|
Control
n=11 participants at risk
Patients will receive usual care only.
|
|---|---|---|
|
Cardiac disorders
systolic blood pressure above goal
|
7.1%
1/14 • Number of events 1 • Up to 90 days
|
0.00%
0/11 • Up to 90 days
|
|
Musculoskeletal and connective tissue disorders
cramping
|
7.1%
1/14 • Number of events 1 • Up to 90 days
|
0.00%
0/11 • Up to 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place