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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline

Results posted on

2025-07-29

Participant Flow

Participant milestones

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

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: 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

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

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

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

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

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

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: Baseline

Population: 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

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

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

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

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

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: 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

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: 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

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

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

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

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: Baseline

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

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

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

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

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: 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

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

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

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

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: Baseline

The Six-Minute Walk Test (6MWT) measures total distance traveled over a 6 minute period.

Outcome measures

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

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

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

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

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: 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 Paretic step length (cm) across two 2-minute walking trials

Outcome measures

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: 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

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

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

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: Baseline

Percentage of gait cycle spent in single limb support

Outcome measures

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

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: Baseline

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

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

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: 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.

Steps walked per minute during two 2-minute walking trials

Outcome measures

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

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: 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

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

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: Baseline

Mean peak degree of paretic knee flexion across two 2-minute walking trials

Outcome measures

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

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: Baseline

Mean peak degree of non-paretic knee flexion across two 2-minute walking trials

Outcome measures

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

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: 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

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

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: 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.

Non-Paretic peak degree of non-paretic dorsiflexion across two 2-minute walking trials

Outcome measures

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

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: 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

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

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: 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

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

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

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

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

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

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: Baseline

Population: 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

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: baseline

Population: individuals with chronic stroke with residual upper limb paresis

The Wolf Motor Function Test includes Grip strength measured by dynamometer

Outcome measures

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: 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

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

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: Baseline

Population: 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

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

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

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

Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths

Upper Extremity Repetitive Task Practice Only

Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths

Serious adverse events

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

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

Phone: 216-445-9815

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place