Trial Outcomes & Findings for Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation (NCT NCT03819764)
NCT ID: NCT03819764
Last Updated: 2025-07-29
Results Overview
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
COMPLETED
NA
60 participants
Baseline
2025-07-29
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise & Repetitive Task Practice
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
29
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: 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
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
60.2 years
STANDARD_DEVIATION 9.8 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: BaselineThe Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
32.5 score on a scale
Standard Deviation 16.6
|
32.8 score on a scale
Standard Deviation 18.6
|
PRIMARY outcome
Timeframe: midpoint (4 weeks from Baseline)The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
44.0 score on a scale
Standard Deviation 11.8
|
41.2 score on a scale
Standard Deviation 13.4
|
PRIMARY outcome
Timeframe: end of treatment (8 weeks from Baseline)The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
44.6 score on a scale
Standard Deviation 12.5
|
42.1 score on a scale
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: end of treatment +4 weeks (12 weeks from Baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
44.6 score on a scale
Standard Deviation 12.5
|
42.1 score on a scale
Standard Deviation 13.5
|
PRIMARY outcome
Timeframe: end of treatment +6 months (8 months from Baseline)The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
45.1 score on a scale
Standard Deviation 12.8
|
43.7 score on a scale
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: end of treatment +1 year (14 months from Baseline)The Fugl-Meyer Assessment is a 33 item assessment of post-stroke upper extremity impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Fugl-Meyer Assessment (FMA)
|
44.8 score on a scale
Standard Deviation 12.9
|
46.8 score on a scale
Standard Deviation 13.6
|
PRIMARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual upper limb paresis
The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Action Research Arm Test (ARAT)
ARAT Total
|
32.5 score on a scale
Standard Deviation 16.6
|
32.8 score on a scale
Standard Deviation 18.6
|
|
Action Research Arm Test (ARAT)
ARAT Grasp
|
11.2 score on a scale
Standard Deviation 5.7
|
11.4 score on a scale
Standard Deviation 6.8
|
|
Action Research Arm Test (ARAT)
ARAT Grip
|
6.8 score on a scale
Standard Deviation 3.1
|
6.0 score on a scale
Standard Deviation 3.9
|
|
Action Research Arm Test (ARAT)
ARAT Pinch
|
8.0 score on a scale
Standard Deviation 6.6
|
8.5 score on a scale
Standard Deviation 7.0
|
|
Action Research Arm Test (ARAT)
ARAT Gross
|
6.5 score on a scale
Standard Deviation 2.3
|
6.9 score on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: end of treatment (8 weeks from Baseline)The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Action Research Arm Test (ARAT)
ARAT Total
|
37.7 score on a scale
Standard Deviation 17.9
|
36.4 score on a scale
Standard Deviation 18.5
|
|
Action Research Arm Test (ARAT)
ARAT Grasp
|
13.0 score on a scale
Standard Deviation 6.2
|
12.6 score on a scale
Standard Deviation 6.6
|
|
Action Research Arm Test (ARAT)
ARAT Grip
|
7.6 score on a scale
Standard Deviation 3.6
|
7.1 score on a scale
Standard Deviation 4.0
|
|
Action Research Arm Test (ARAT)
ARAT Pinch
|
9.9 score on a scale
Standard Deviation 6.9
|
9.4 score on a scale
Standard Deviation 7.1
|
|
Action Research Arm Test (ARAT)
ARAT Gross
|
7.2 score on a scale
Standard Deviation 2.4
|
7.3 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: end of treatment +4 weeks (12 weeks from Baseline)The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Action Research Arm Test (ARAT)
ARAT Total
|
39.3 score on a scale
Standard Deviation 18.2
|
36.2 score on a scale
Standard Deviation 19.8
|
|
Action Research Arm Test (ARAT)
ARAT Grasp
|
13.7 score on a scale
Standard Deviation 6.0
|
12.6 score on a scale
Standard Deviation 6.8
|
|
Action Research Arm Test (ARAT)
ARAT Grip
|
7.8 score on a scale
Standard Deviation 4.1
|
7.0 score on a scale
Standard Deviation 4.4
|
|
Action Research Arm Test (ARAT)
ARAT Pinch
|
10.4 score on a scale
Standard Deviation 7.1
|
9.4 score on a scale
Standard Deviation 7.3
|
|
Action Research Arm Test (ARAT)
ARAT Gross
|
7.4 score on a scale
Standard Deviation 2.4
|
7.2 score on a scale
Standard Deviation 2.41
|
PRIMARY outcome
Timeframe: end of treatment +6 months (8 months from Baseline)The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Action Research Arm Test (ARAT)
ARAT Total
|
37.1 score on a scale
Standard Deviation 19.4
|
39.1 score on a scale
Standard Deviation 18.3
|
|
Action Research Arm Test (ARAT)
ARAT Grasp
|
13.2 score on a scale
Standard Deviation 6.4
|
13.6 score on a scale
Standard Deviation 6.6
|
|
Action Research Arm Test (ARAT)
ARAT Grip
|
7.5 score on a scale
Standard Deviation 4.2
|
7.4 score on a scale
Standard Deviation 4.2
|
|
Action Research Arm Test (ARAT)
ARAT Pinch
|
9.1 score on a scale
Standard Deviation 7.8
|
10.2 score on a scale
Standard Deviation 7.2
|
|
Action Research Arm Test (ARAT)
ARAT Gross
|
7.2 score on a scale
Standard Deviation 2.5
|
8.0 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: end of treatment +1 year (14 months from Baseline)The Action Research Arm Test is an assessment of post-stroke upper extremity function. Total score is reported, scores range from 0-57, with higher scores indicating a better outcome. The test includes 4 subscales: grasp (6 items, score range 0-18), grip (4 items, score range 0-12), pinch (6 items, score range 0-18), and gross motor (3 items, score range 0-9 ) which are added up for the total score. For all subscales, higher scores indicate better function.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Action Research Arm Test (ARAT)
ARAT Total
|
38.5 score on a scale
Standard Deviation 18.4
|
40.9 score on a scale
Standard Deviation 17.6
|
|
Action Research Arm Test (ARAT)
ARAT Grasp
|
14.2 score on a scale
Standard Deviation 6.0
|
14.1 score on a scale
Standard Deviation 6.3
|
|
Action Research Arm Test (ARAT)
ARAT Grip
|
7.1 score on a scale
Standard Deviation 4.0
|
8.0 score on a scale
Standard Deviation 4.1
|
|
Action Research Arm Test (ARAT)
ARAT Pinch
|
10.0 score on a scale
Standard Deviation 7.5
|
10.7 score on a scale
Standard Deviation 7.2
|
|
Action Research Arm Test (ARAT)
ARAT Gross
|
7.3 score on a scale
Standard Deviation 2.5
|
8.0 score on a scale
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test includes 15 timed tasks for the affected upper extremity. Times for timed tasks are transformed and reported as geometric mean (standard deviation). Lower times indicate better performance.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT)
|
11.0 time in seconds
Standard Deviation 3.0
|
14.9 time in seconds
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: BaselineThe Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Stroke Impact Scale (SIS)
SIS Physical Problem
|
50.6 score on a scale
Standard Deviation 17.1
|
47.8 score on a scale
Standard Deviation 19.4
|
|
Stroke Impact Scale (SIS)
SIS Memory and Thinking
|
86.5 score on a scale
Standard Deviation 13.4
|
83.7 score on a scale
Standard Deviation 16.4
|
|
Stroke Impact Scale (SIS)
SIS Feelings
|
80.0 score on a scale
Standard Deviation 14.4
|
69.8 score on a scale
Standard Deviation 18.7
|
|
Stroke Impact Scale (SIS)
SIS Communication
|
87.2 score on a scale
Standard Deviation 19.4
|
83.9 score on a scale
Standard Deviation 18.8
|
|
Stroke Impact Scale (SIS)
SIS ADL's
|
73.4 score on a scale
Standard Deviation 14.5
|
67.8 score on a scale
Standard Deviation 18.8
|
|
Stroke Impact Scale (SIS)
SIS Mobility
|
81.5 score on a scale
Standard Deviation 12.9
|
75.9 score on a scale
Standard Deviation 17.7
|
|
Stroke Impact Scale (SIS)
SIS Hand Use
|
41.9 score on a scale
Standard Deviation 27.2
|
42.5 score on a scale
Standard Deviation 28.9
|
|
Stroke Impact Scale (SIS)
SIS Meaningful Activities
|
61.4 score on a scale
Standard Deviation 23.8
|
63.0 score on a scale
Standard Deviation 25.8
|
|
Stroke Impact Scale (SIS)
SIS Stroke Recovery Score
|
62.3 score on a scale
Standard Deviation 20.8
|
52.5 score on a scale
Standard Deviation 23.3
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Stroke Impact Scale (SIS)
SIS Physical Problem
|
58.4 score on a scale
Standard Deviation 14.9
|
54.8 score on a scale
Standard Deviation 22.6
|
|
Stroke Impact Scale (SIS)
SIS Memory and Thinking
|
88.3 score on a scale
Standard Deviation 14.8
|
83.7 score on a scale
Standard Deviation 19.9
|
|
Stroke Impact Scale (SIS)
SIS Feelings
|
81.6 score on a scale
Standard Deviation 14.2
|
77.6 score on a scale
Standard Deviation 16.5
|
|
Stroke Impact Scale (SIS)
SIS Communication
|
87.6 score on a scale
Standard Deviation 17.6
|
88.9 score on a scale
Standard Deviation 17.2
|
|
Stroke Impact Scale (SIS)
SIS ADLs
|
76.9 score on a scale
Standard Deviation 13.8
|
74.4 score on a scale
Standard Deviation 16.2
|
|
Stroke Impact Scale (SIS)
SIS Mobility
|
84.4 score on a scale
Standard Deviation 12.7
|
78.3 score on a scale
Standard Deviation 18.2
|
|
Stroke Impact Scale (SIS)
SIS Hand Use
|
54.5 score on a scale
Standard Deviation 26.4
|
52.6 score on a scale
Standard Deviation 26.3
|
|
Stroke Impact Scale (SIS)
SIS Meaningful Activities
|
73.8 score on a scale
Standard Deviation 19.0
|
69.8 score on a scale
Standard Deviation 17.7
|
|
Stroke Impact Scale (SIS)
SIS Stroke Recovery
|
64.6 score on a scale
Standard Deviation 19.4
|
63.4 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: end of treatment +6 months (8 months from Baseline)The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Stroke Impact Scale (SIS)
SIS Physical Problem
|
60.8 score on a scale
Standard Deviation 20.2
|
54.9 score on a scale
Standard Deviation 22.3
|
|
Stroke Impact Scale (SIS)
SIS Memory and Thinking
|
87.3 score on a scale
Standard Deviation 15.1
|
85.3 score on a scale
Standard Deviation 15.2
|
|
Stroke Impact Scale (SIS)
SIS Feelings
|
83.5 score on a scale
Standard Deviation 12.7
|
79.5 score on a scale
Standard Deviation 15.1
|
|
Stroke Impact Scale (SIS)
SIS Communication
|
89.9 score on a scale
Standard Deviation 15.6
|
91.0 score on a scale
Standard Deviation 11.0
|
|
Stroke Impact Scale (SIS)
SIS ADL's
|
77.0 score on a scale
Standard Deviation 15.4
|
77.9 score on a scale
Standard Deviation 13.7
|
|
Stroke Impact Scale (SIS)
SIS Mobility
|
84.6 score on a scale
Standard Deviation 13.3
|
80.8 score on a scale
Standard Deviation 14.4
|
|
Stroke Impact Scale (SIS)
SIS Hand Use
|
50.5 score on a scale
Standard Deviation 27.8
|
52.6 score on a scale
Standard Deviation 26.7
|
|
Stroke Impact Scale (SIS)
SIS Meaningful Activities
|
75.0 score on a scale
Standard Deviation 17.4
|
67.6 score on a scale
Standard Deviation 20.3
|
|
Stroke Impact Scale (SIS)
SIS Stroke Recovery Score
|
68.0 score on a scale
Standard Deviation 17.7
|
66.5 score on a scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: end of treatment +1 year (14 months from Baseline)The Stroke Impact Scale is a self-reported questionnaire evaluating quality of life. 8 domains are assessed including: physical problems, memory and thinking, feelings, communication, activities of daily living (ADLs), mobility, hand use, and meaningful activities. Scores for all domains are normalized and range from 0-100, with higher scores indicating a better self-perceived quality of life. The last domain (stroke recovery) asks the individual to rate their recovery on a scale of 0-100, with 0 indicating no recovery and 100 indicating full recovery.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Stroke Impact Scale (SIS)
SIS Physical Problem
|
60.1 score on a scale
Standard Deviation 22.1
|
59.4 score on a scale
Standard Deviation 19.7
|
|
Stroke Impact Scale (SIS)
SIS Memory and Thinking
|
88.1 score on a scale
Standard Deviation 16.6
|
90.9 score on a scale
Standard Deviation 11.6
|
|
Stroke Impact Scale (SIS)
SIS Feelings
|
82.5 score on a scale
Standard Deviation 16.8
|
81.5 score on a scale
Standard Deviation 14.1
|
|
Stroke Impact Scale (SIS)
SIS Communication
|
88.8 score on a scale
Standard Deviation 19.2
|
91.2 score on a scale
Standard Deviation 10.7
|
|
Stroke Impact Scale (SIS)
SIS ADL'S
|
74.5 score on a scale
Standard Deviation 16.1
|
77.0 score on a scale
Standard Deviation 14.4
|
|
Stroke Impact Scale (SIS)
SIS Mobility
|
83.3 score on a scale
Standard Deviation 12.6
|
84.3 score on a scale
Standard Deviation 12.3
|
|
Stroke Impact Scale (SIS)
SIS Hand Use
|
49.0 score on a scale
Standard Deviation 28.1
|
52.8 score on a scale
Standard Deviation 24.9
|
|
Stroke Impact Scale (SIS)
SIS Meaningful Activities
|
69.3 score on a scale
Standard Deviation 26.9
|
73.0 score on a scale
Standard Deviation 19.2
|
|
Stroke Impact Scale (SIS)
SIS Stroke Recovery Score
|
65.7 score on a scale
Standard Deviation 20.6
|
66.9 score on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: BaselineThe Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical
|
39.6 T-score
Standard Deviation 6.6
|
40.1 T-score
Standard Deviation 5.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
49.7 T-score
Standard Deviation 8.1
|
49.9 T-score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
49.2 T-score
Standard Deviation 7.9
|
48.9 T-score
Standard Deviation 7.6
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
47.8 T-score
Standard Deviation 8.7
|
48.0 T-score
Standard Deviation 8.6
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
46.8 T-score
Standard Deviation 9.9
|
45.5 T-score
Standard Deviation 9.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Participation
|
46.3 T-score
Standard Deviation 8.4
|
45.8 T-score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain Interference
|
49.0 T-score
Standard Deviation 8.5
|
47.4 T-score
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical
|
40.8 T-score
Standard Deviation 6.5
|
41.3 T-score
Standard Deviation 5.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
48.8 T-score
Standard Deviation 9.4
|
48.2 T-score
Standard Deviation 9.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
49.6 T-score
Standard Deviation 8.6
|
49.2 T-score
Standard Deviation 8.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
48.5 T-score
Standard Deviation 8.7
|
47.1 T-score
Standard Deviation 8.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
46.2 T-score
Standard Deviation 9.0
|
44.7 T-score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Participation
|
49.3 T-score
Standard Deviation 9.1
|
49.9 T-score
Standard Deviation 9.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain Interference
|
49.7 T-score
Standard Deviation 8.8
|
48.2 T-score
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: end of treatment +6 months (8 months from Baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.easured.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical
|
42.0 T-score
Standard Deviation 7.6
|
41.4 T-score
Standard Deviation 7.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
47.5 T-score
Standard Deviation 9.0
|
47.6 T-score
Standard Deviation 9.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
48.3 T-score
Standard Deviation 7.6
|
47.6 T-score
Standard Deviation 7.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
47.1 T-score
Standard Deviation 9.8
|
45.3 T-score
Standard Deviation 10.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
45.2 T-score
Standard Deviation 8.9
|
44.5 T-score
Standard Deviation 10.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Participation
|
51.0 T-score
Standard Deviation 9.7
|
51.5 T-score
Standard Deviation 10.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain Interference
|
51.3 T-score
Standard Deviation 8.0
|
50.0 T-score
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: end of treatment +1 year (14 months from Baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System (PROMIS-29) is a self-reported questionnaire evaluating physical, mental, and social health. T-scores are reported separately for Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Physical Function, and Pain Interference. * A score of 50 represents the population mean. * A score of 40 is one standard deviation lower than the mean of the reference population. * A score of 60 is one standard deviation higher than the mean of the reference population. * For PROMIS measures, higher scores for domains measuring symptoms is indicative of greater symptom burden. Therefore, higher scores are worse for fatigue, anxiety, depression, sleep disturbance, and pain interference. For the domains of Physical Function and Participation, higher scores indicate better function and better participation, respectively.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Physical
|
41.1 T-score
Standard Deviation 6.8
|
40.5 T-score
Standard Deviation 5.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Anxiety
|
47.9 T-score
Standard Deviation 9.7
|
49.1 T-score
Standard Deviation 10.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Depression
|
48.2 T-score
Standard Deviation 8.6
|
48.1 T-score
Standard Deviation 9.2
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Fatigue
|
46.8 T-score
Standard Deviation 8.6
|
47.7 T-score
Standard Deviation 9.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Sleep Disturbance
|
45.2 T-score
Standard Deviation 9.7
|
43.6 T-score
Standard Deviation 10.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Participation
|
49.6 T-score
Standard Deviation 9.2
|
48.4 T-score
Standard Deviation 10.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Pain Interference
|
49.4 T-score
Standard Deviation 8.6
|
49.4 T-score
Standard Deviation 9.2
|
SECONDARY outcome
Timeframe: BaselineThe Center for Epidemiological Studies-Depression (CES-D) is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. A score of 16 or more is indicative of depression.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Center for Epidemiological Studies-Depression (CES-D)
|
11.3 units on a scale
Standard Deviation 8.5
|
9.6 units on a scale
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)The Center for Epidemiological Studies-Depression (CES-D) is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. A score of 16 or more is indicative of depression.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Center for Epidemiological Studies-Depression (CES-D)
|
9.9 units on a scale
Standard Deviation 9.3
|
8.8 units on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: end of treatment +6 months (8 months from Baseline)The Center for Epidemiological Studies-Depression (CES-D) is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. A score of 16 or more is indicative of depression.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Center for Epidemiological Studies-Depression (CES-D)
|
9.3 units on a scale
Standard Deviation 7.8
|
8.6 units on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: end of treatment +1 year (14 months from Baseline)The Center for Epidemiological Studies-Depression (CES-D) is a 20 item assessment of depressive symptomology. Total score is reported, scores range from 0-60, with higher scores indicating higher risk of depression. A score of 16 or more is indicative of depression.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Center for Epidemiological Studies-Depression (CES-D)
|
9.3 units on a scale
Standard Deviation 8.3
|
9.7 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: BaselineThe Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
|
264.4 Meters
Standard Error 118.4
|
285.5 Meters
Standard Error 160.3
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks)The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
|
327.1 Meters
Standard Deviation 141.2
|
316.9 Meters
Standard Deviation 170.0
|
SECONDARY outcome
Timeframe: end of treatment +4 weeks (12 weeks from Baseline)The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
|
339.3 units on a scale
Standard Deviation 156.7
|
315.1 units on a scale
Standard Deviation 170.5
|
SECONDARY outcome
Timeframe: end of treatment +6 months (8 months from Baseline)The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
|
339.3 Meters
Standard Deviation 156.7
|
315.1 Meters
Standard Deviation 170.5
|
SECONDARY outcome
Timeframe: end of treatment +1 year (14 months from Baseline)The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
|
320.8 Meters
Standard Deviation 166.5
|
336.7 Meters
Standard Deviation 170.3
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean Paretic step length (cm) across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Step Length
|
40.4 Centimeters
Standard Deviation 14.1
|
45.6 Centimeters
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean Non-Paretic step length (cm) across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Step Length
|
40.1 Centimeters
Standard Deviation 15.5
|
44.2 Centimeters
Standard Deviation 14.9
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Mean Paretic step length (cm) across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Step Length
|
45.0 Centimeters
Standard Deviation 12.6
|
46.9 Centimeters
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean Non-Paretic step length (cm) across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Step Length
|
45.0 Centimeters
Standard Deviation 15.3
|
46.1 Centimeters
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: BaselinePercentage of gait cycle spent in single limb support
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Single Limb Percentage
|
29.1 Percent
Standard Deviation 4.79
|
30.1 Percent
Standard Deviation 2.64
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual upper limb paresis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean percentage of gait cycle spent in stance phase on the Non-Paretic lower extremity across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Single Limb Percentage
|
29.8 Percent
Standard Deviation 4.73
|
30.5 Percent
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: BaselineThe modified Rankin Scale is a global outcome on a scale of 0-6 used to assess the degree of disability in patients with stroke as follows: 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Modified Rankin Scale
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis
The modified Rankin Scale is a global outcome on a scale of 0-6 used to assess the degree of disability in patients with stroke as follows: 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Modified Rankin Scale
|
2 score on a scale
Interval 1.0 to 3.0
|
2 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Steps walked per minute during two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=25 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Walking Cadence
|
82.1 steps/min
Standard Deviation 17.2
|
86.1 steps/min
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Steps walked per minute during two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Walking Cadence
|
86.1 steps/min
Standard Deviation 17.3
|
85.8 steps/min
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Percentage of gait cycle spent in single limb support
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Single Limb Percentage
|
26.8 Percentage
Standard Deviation 3.88
|
28.6 Percentage
Standard Deviation 2.76
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Percentage of gait cycle spent in single limb support
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Single Limb Percentage
|
27.9 Percent
Standard Deviation 3.40
|
28.9 Percent
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: BaselineMean peak degree of paretic knee flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Knee Range of Motion
|
43.0 Degrees
Standard Deviation 16.9
|
54.1 Degrees
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of paretic knee flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Knee Range of Motion
|
44.0 Degrees
Standard Deviation 17.5
|
53.4 Degrees
Standard Deviation 12.5
|
SECONDARY outcome
Timeframe: BaselineMean peak degree of non-paretic knee flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Knee Range of Motion
|
53.6 Degrees
Standard Deviation 11.85
|
60.5 Degrees
Standard Deviation 9.12
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of non-paretic knee flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Knee Range of Motion
|
54.8 Degrees
Standard Deviation 10.9
|
62.4 Degrees
Standard Deviation 6.41
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Ankle Range of Motion
|
17.8 Degrees
Standard Deviation 5.38
|
19.5 Degrees
Standard Deviation 6.45
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of paretic ankle dorsiflexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Ankle Range of Motion
|
19.1 Degrees
Standard Deviation 5.46
|
19.1 Degrees
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Ankle Range of Motion
|
23.3 Degrees
Standard Deviation 8.74
|
23.7 Degrees
Standard Deviation 7.28
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of non-paretic ankle dorsiflexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Ankle Range of Motion
|
24.8 Degrees
Standard Deviation 8.48
|
23.2 Degrees
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of paretic hip flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Hip Range of Motion (Sagittal Plane)
|
33.2 Degrees
Standard Deviation 9.39
|
37.4 Degrees
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of paretic hip flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Paretic Hip Range of Motion (Sagittal Plane)
|
35.6 Degrees
Standard Deviation 10.0
|
39.5 Degrees
Standard Deviation 7.64
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Hip Range of Motion (Sagittal Plane)
|
36.9 Degrees
Standard Deviation 9.35
|
41.3 Degrees
Standard Deviation 6.14
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from Baseline)Population: individuals with chronic stroke and residual hemiparesis who opted to have biomechanical gait assessment completed. This was a secondary outcome and included a subset of the total sample.
Mean peak degree of non-paretic hip flexion across two 2-minute walking trials
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=25 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=20 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Non-Paretic Hip Range of Motion (Sagittal Plane)
|
39.9 Degrees
Standard Deviation 9.37
|
43.0 Degrees
Standard Deviation 5.89
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks from baseline)Population: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Functional Ability Score
|
3.4 score on a scale
Standard Deviation 1.3
|
3.2 score on a scale
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks from baseline)Population: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test includes Grip strength measured by dynamometer
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Grip Strength
|
14.2 kg
Standard Deviation 8.5
|
14.1 kg
Standard Deviation 9.0
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks from baseline)Population: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test includes the amount of weight the individual can lift onto a box using a wrist cuff weight ranging from 1-20 pounds. Higher indicates greater strength.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Weight to Box
|
10.6 pounds
Standard Deviation 7.0
|
10.8 pounds
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: end of treatment (8 weeks from baseline)Population: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test includes 15 timed tasks for the affected upper extremity. Times for timed tasks are transformed and reported as geometric mean (standard deviation). Lower times indicate better performance.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT)
|
8.2 time in seconds
Standard Deviation 3.3
|
10.0 time in seconds
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke with residual upper limb paresis
The WMFT Functional Ability Score quantifies movement quality. Scores range from 0-75, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Functional Ability Score
|
2.4 score on a scale
Standard Deviation 1.1
|
2.7 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: baselinePopulation: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test includes Grip strength measured by dynamometer
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Grip Strength
|
13.8 kg
Standard Deviation 7.9
|
13.8 kg
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: baselinePopulation: individuals with chronic stroke with residual upper limb paresis
The Wolf Motor Function Test includes the amount of weight the individual can lift onto a box using a wrist cuff weight ranging from 1-20 pounds. Higher indicates greater strength.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Wolf Motor Function Test (WMFT) Weight to Box
|
8.2 pounds
Standard Deviation 6.3
|
8.7 pounds
Standard Deviation 7.2
|
SECONDARY outcome
Timeframe: End of Treatment (8 weeks following baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
|
2.3 units on a scale
Standard Deviation 2.6
|
2.6 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: BaselinePopulation: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System includes pain rated rated on a 0-10 scale with higher scores indicative of greater pain.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
|
2.4 units on a scale
Standard Deviation 2.1
|
2.4 units on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: end of treatment + 6 months (8 months from baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
|
2.3 units on a scale
Standard Deviation 2.1
|
2.4 units on a scale
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: end of treatment + 12 months (14 months from baseline)Population: individuals with chronic stroke and residual upper limb paresis
The Patient-Reported Outcomes Measurement Information System includes pain rated on a 0-10 scale with higher scores indicative of greater pain.
Outcome measures
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 Participants
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 Participants
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS-29) Pain Intensity
|
2.7 units on a scale
Standard Deviation 2.8
|
2.7 units on a scale
Standard Deviation 2.3
|
Adverse Events
Aerobic Exercise & Repetitive Task Practice
Upper Extremity Repetitive Task Practice Only
Serious adverse events
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 participants at risk
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 participants at risk
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Reproductive system and breast disorders
Cancer Diagnosis
|
3.3%
1/30 • Number of events 1 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
0.00%
0/30 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/30 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
3.3%
1/30 • Number of events 1 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
|
Vascular disorders
Stroke
|
3.3%
1/30 • Number of events 1 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
3.3%
1/30 • Number of events 1 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
Other adverse events
| Measure |
Aerobic Exercise & Repetitive Task Practice
n=30 participants at risk
Participants will perform the following:
1. 45 minutes of cycling
2. 45 minutes of upper extremity repetitive arm exercises
Aerobic Exercise: Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than self-selected speed
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
Upper Extremity Repetitive Task Practice Only
n=30 participants at risk
Participants will perform the following:
1\. 90 minutes of upper extremity repetitive arm exercises
Upper Extremity Repetitive Task Practice: Repetitive arm exercises
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Injury
|
10.0%
3/30 • Number of events 3 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
0.00%
0/30 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
3.3%
1/30 • Number of events 3 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
26.7%
8/30 • Number of events 13 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
|
Musculoskeletal and connective tissue disorders
Leg Swelling
|
3.3%
1/30 • Number of events 1 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
0.00%
0/30 • Adverse experiences were collected up to 2 years from the start to the completion of the study.
|
Additional Information
Dr. Susan Linder, PT, DPT, PhD
The Cleveland Clinic Foundation
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place