Trial Outcomes & Findings for Forced Aerobic Exercise for Stroke Rehabilitation (NCT NCT02494518)
NCT ID: NCT02494518
Last Updated: 2019-03-28
Results Overview
Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends
Results posted on
2019-03-28
Participant Flow
Participant milestones
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Forced Aerobic Exercise for Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=11 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=12 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=11 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Continuous
|
54.91 years
STANDARD_DEVIATION 10.69 • n=5 Participants
|
59.33 years
STANDARD_DEVIATION 13.84 • n=7 Participants
|
60.45 years
STANDARD_DEVIATION 11.25 • n=5 Participants
|
58.26 years
STANDARD_DEVIATION 11.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
12 participants
n=7 Participants
|
11 participants
n=5 Participants
|
34 participants
n=4 Participants
|
|
Fugl-Meyer Assessment
|
35.73 units on a scale
STANDARD_DEVIATION 8.71 • n=5 Participants
|
35.92 units on a scale
STANDARD_DEVIATION 10.11 • n=7 Participants
|
32.09 units on a scale
STANDARD_DEVIATION 7.44 • n=5 Participants
|
34.62 units on a scale
STANDARD_DEVIATION 8.77 • n=4 Participants
|
|
Wolf Motor Function Test
|
55.09 units on a scale
STANDARD_DEVIATION 12.19 • n=5 Participants
|
52.83 units on a scale
STANDARD_DEVIATION 9.49 • n=7 Participants
|
51.91 units on a scale
STANDARD_DEVIATION 8.79 • n=5 Participants
|
53.26 units on a scale
STANDARD_DEVIATION 10.02 • n=4 Participants
|
|
Stroke Impact Scale
|
53.64 units on a scale
STANDARD_DEVIATION 23.46 • n=5 Participants
|
51.67 units on a scale
STANDARD_DEVIATION 18.13 • n=7 Participants
|
54.09 units on a scale
STANDARD_DEVIATION 20.23 • n=5 Participants
|
53.09 units on a scale
STANDARD_DEVIATION 20.04 • n=4 Participants
|
|
Metabolic Stress Test
|
15.23 mL/kg/min
STANDARD_DEVIATION 3.84 • n=5 Participants
|
16.72 mL/kg/min
STANDARD_DEVIATION 4.06 • n=7 Participants
|
14.58 mL/kg/min
STANDARD_DEVIATION 3.48 • n=5 Participants
|
15.54 mL/kg/min
STANDARD_DEVIATION 3.81 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4
Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Fugl Meyer Assessment
Baseline to Midpoint
|
6.90 units on a scale
Standard Deviation 5.55
|
4.00 units on a scale
Standard Deviation 3.27
|
6.25 units on a scale
Standard Deviation 3.65
|
|
Fugl Meyer Assessment
Baseline to EOT
|
10.10 units on a scale
Standard Deviation 5.32
|
6.50 units on a scale
Standard Deviation 3.47
|
8.88 units on a scale
Standard Deviation 4.76
|
|
Fugl Meyer Assessment
Baseline to EOT+4
|
11.11 units on a scale
Standard Deviation 5.69
|
7.10 units on a scale
Standard Deviation 4.51
|
9.25 units on a scale
Standard Deviation 5.75
|
PRIMARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4
Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Wolf Motor Function Test
Baseline to EOT
|
7.80 units on a scale
Standard Deviation 6.09
|
6.40 units on a scale
Standard Deviation 3.17
|
10.50 units on a scale
Standard Deviation 6.87
|
|
Wolf Motor Function Test
Baseline to EOT+4
|
9.22 units on a scale
Standard Deviation 6.67
|
9.60 units on a scale
Standard Deviation 2.59
|
10.88 units on a scale
Standard Deviation 6.77
|
PRIMARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4
Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Stroke Impact Scale
Baseline to EOT
|
15.00 units on a scale
Standard Deviation 11.55
|
14.50 units on a scale
Standard Deviation 14.03
|
9.38 units on a scale
Standard Deviation 12.08
|
|
Stroke Impact Scale
Baseline to EOT+4
|
19.44 units on a scale
Standard Deviation 12.10
|
14.00 units on a scale
Standard Deviation 20.25
|
21.25 units on a scale
Standard Deviation 19.04
|
PRIMARY outcome
Timeframe: Change from baseline to follow up assessments at end of 8 week interventionCycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=9 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Metabolic Stress Test
|
0.02 mL/kg/min
Standard Error 1.35
|
1.09 mL/kg/min
Standard Error 1.70
|
0.40 mL/kg/min
Standard Error 0.70
|
SECONDARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4
Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Action Research Arm Test
Baseline to EOT
|
8.60 units on a scale
Standard Deviation 6.24
|
6.30 units on a scale
Standard Deviation 4.83
|
6.38 units on a scale
Standard Deviation 4.96
|
|
Action Research Arm Test
Baseline to EOT+4
|
8.56 units on a scale
Standard Deviation 4.98
|
7.50 units on a scale
Standard Deviation 5.50
|
7.13 units on a scale
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4
Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Center for Epidemiological Studies-Depression
Baseline to EOT
|
-5.20 units on a scale
Standard Deviation 7.44
|
-0.30 units on a scale
Standard Deviation 8.31
|
-2.00 units on a scale
Standard Deviation 5.53
|
|
Center for Epidemiological Studies-Depression
Baseline to EOT+4
|
-3.67 units on a scale
Standard Deviation 6.63
|
-2.60 units on a scale
Standard Deviation 5.46
|
-3.75 units on a scale
Standard Deviation 7.21
|
SECONDARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4
Matching letters and symbols to test cognition. The reported data is change in total number correct.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Processing Speed Test
Baseline to EOT
|
0.90 number correct
Standard Deviation 4.68
|
1.88 number correct
Standard Deviation 4.22
|
2.71 number correct
Standard Deviation 6.32
|
|
Processing Speed Test
Baseline to EOT+4
|
2.89 number correct
Standard Deviation 7.52
|
3.25 number correct
Standard Deviation 5.15
|
6.38 number correct
Standard Deviation 10.27
|
SECONDARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4. One individual in VE+RTP did not complete the NHPT at EOT+4.
Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Nine Hole Peg Test
Baseline to EOT+4
|
-8.10 seconds
Standard Deviation 10.58
|
-7.81 seconds
Standard Deviation 34.89
|
-29.15 seconds
Standard Deviation 32.75
|
|
Nine Hole Peg Test
Baseline to EOT
|
-8.07 seconds
Standard Deviation 15.71
|
-16.15 seconds
Standard Deviation 45.64
|
-19.35 seconds
Standard Deviation 21.51
|
SECONDARY outcome
Timeframe: Change from baseline to end of 8 week intervention, and 4 weeks after the intervention endsPopulation: Two individuals in FE+RTP did not complete this assessment at EOT+4
Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.
Outcome measures
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=10 Participants
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=8 Participants
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Six Minute Walk Test
Baseline to EOT
|
133.20 feet
Standard Deviation 107.78
|
188.70 feet
Standard Deviation 155.22
|
-21.75 feet
Standard Deviation 111.76
|
|
Six Minute Walk Test
Baseline to EOT+4
|
78.50 feet
Standard Deviation 224.32
|
127.70 feet
Standard Deviation 190.05
|
78.88 feet
Standard Deviation 202.38
|
Adverse Events
Forced Exercise & Upper Extremity Repetitive Task Practice
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Voluntary Exercise & Upper Extremity Repetitive Task Practice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stroke Education & Upper Extremity Repetitive Task Practice
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=11 participants at risk
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=12 participants at risk
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=11 participants at risk
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
General disorders
Fall
|
0.00%
0/11 • 12 weeks from baseline assessment
|
0.00%
0/12 • 12 weeks from baseline assessment
|
9.1%
1/11 • Number of events 1 • 12 weeks from baseline assessment
|
Other adverse events
| Measure |
Forced Exercise & Upper Extremity Repetitive Task Practice
n=11 participants at risk
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Forced Exercise \& Upper Extremity Repetitive Task Practice
|
Voluntary Exercise & Upper Extremity Repetitive Task Practice
n=12 participants at risk
Participants will perform the following:
1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed
2. 45 minutes of upper extremity repetitive arm exercises
Voluntary Exercise \& Upper Extremity Repetitive Task Practice
|
Stroke Education & Upper Extremity Repetitive Task Practice
n=11 participants at risk
Participants will perform the following:
1. 45 minutes of stroke education
2. 45 minutes of upper extremity repetitive arm exercises
Stroke Education \& Upper Extremity Repetitive Task Practice
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Integrity
|
9.1%
1/11 • Number of events 1 • 12 weeks from baseline assessment
|
0.00%
0/12 • 12 weeks from baseline assessment
|
0.00%
0/11 • 12 weeks from baseline assessment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place