Trial Outcomes & Findings for Heart-Brain Retraining for Stroke Rehabilitation (NCT NCT02076776)
NCT ID: NCT02076776
Last Updated: 2018-08-31
Results Overview
This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)
Results posted on
2018-08-31
Participant Flow
One participant consented to the study, but had abnormal stress test results. This participant declined follow-up care and withdrew from the study before completing the baseline and randomization process.
Participant milestones
| Measure |
Repetitive Task Practice (RTP)
This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy.
|
Voluntary Cycling + RTP
This group involves one biking session and one RTP session three times per week for eight weeks.
Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Assisted Cycling + RTP
This group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
8
|
6
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heart-Brain Retraining for Stroke Rehabilitation
Baseline characteristics by cohort
| Measure |
Repetitive Task Practice (RTP)
n=6 Participants
This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy.
|
Voluntary Cycling + RTP
n=8 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Assisted Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
61.67 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
59.38 years
STANDARD_DEVIATION 15.57 • n=7 Participants
|
44.83 years
STANDARD_DEVIATION 11.72 • n=5 Participants
|
55.70 years
STANDARD_DEVIATION 13.94 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Wolf Motor Function Test
|
45.17 units on a scale
STANDARD_DEVIATION 17.38 • n=5 Participants
|
49.75 units on a scale
STANDARD_DEVIATION 20.25 • n=7 Participants
|
59.83 units on a scale
STANDARD_DEVIATION 9.06 • n=5 Participants
|
51.40 units on a scale
STANDARD_DEVIATION 16.97 • n=4 Participants
|
|
Fugl-Meyer Assessment
|
26.83 units on a scale
STANDARD_DEVIATION 7.83 • n=5 Participants
|
34.75 units on a scale
STANDARD_DEVIATION 13.58 • n=7 Participants
|
36.17 units on a scale
STANDARD_DEVIATION 7.41 • n=5 Participants
|
32.80 units on a scale
STANDARD_DEVIATION 10.72 • n=4 Participants
|
|
Stroke Impact Scale
|
31.67 units on a scale
STANDARD_DEVIATION 35.73 • n=5 Participants
|
34.38 units on a scale
STANDARD_DEVIATION 28.72 • n=7 Participants
|
50.83 units on a scale
STANDARD_DEVIATION 32.00 • n=5 Participants
|
38.50 units on a scale
STANDARD_DEVIATION 31.29 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)This consists of 2 strength tasks and 15 timed tasks of both the affected UE and the unaffected UE. Total Functional Ability Score is reported, scores range from 0-75, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Repetitive Task Practice (RTP)
n=5 Participants
This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy.
|
Voluntary Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Assisted Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
|---|---|---|---|
|
Wolf Motor Function Test (WMFT)
Baseline
|
45.17 units on a scale
Standard Deviation 17.38
|
49.75 units on a scale
Standard Deviation 20.25
|
59.83 units on a scale
Standard Deviation 9.06
|
|
Wolf Motor Function Test (WMFT)
EOT
|
49.80 units on a scale
Standard Deviation 18.94
|
48.83 units on a scale
Standard Deviation 18.10
|
68.67 units on a scale
Standard Deviation 6.31
|
|
Wolf Motor Function Test (WMFT)
EOT+4
|
50.80 units on a scale
Standard Deviation 21.35
|
50.33 units on a scale
Standard Deviation 19.35
|
69.50 units on a scale
Standard Deviation 5.61
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)This is a 33 item assessment of post-stroke UE impairment. Total score is reported, scores range from 0-66, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Repetitive Task Practice (RTP)
n=5 Participants
This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy.
|
Voluntary Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Assisted Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
|---|---|---|---|
|
The Fugl-Meyer Assessment (FMA)
Baseline
|
26.83 units on a scale
Standard Deviation 7.83
|
34.75 units on a scale
Standard Deviation 13.58
|
36.17 units on a scale
Standard Deviation 7.41
|
|
The Fugl-Meyer Assessment (FMA)
EOT
|
29.80 units on a scale
Standard Deviation 11.97
|
35.33 units on a scale
Standard Deviation 14.65
|
48.50 units on a scale
Standard Deviation 6.75
|
|
The Fugl-Meyer Assessment (FMA)
EOT+4
|
33.40 units on a scale
Standard Deviation 15.04
|
37.00 units on a scale
Standard Deviation 17.56
|
51.17 units on a scale
Standard Deviation 3.06
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, End of Treatment (8 weeks); End of Treatment + 4 week (12 weeks)This is a self-reported questionnaire evaluating quality of life. Normalized Hand Function is reported, scores range from 0-100, with higher scores indicating a better outcome.
Outcome measures
| Measure |
Repetitive Task Practice (RTP)
n=5 Participants
This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy.
|
Voluntary Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Assisted Cycling + RTP
n=6 Participants
This group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
|---|---|---|---|
|
The Stroke Impact Scale (SIS)
EOT
|
35.00 units on a scale
Standard Deviation 26.93
|
45.00 units on a scale
Standard Deviation 41.95
|
68.33 units on a scale
Standard Deviation 15.38
|
|
The Stroke Impact Scale (SIS)
EOT+4
|
34.00 units on a scale
Standard Deviation 22.75
|
51.67 units on a scale
Standard Deviation 37.24
|
66.67 units on a scale
Standard Deviation 22.73
|
|
The Stroke Impact Scale (SIS)
Baseline
|
31.67 units on a scale
Standard Deviation 35.73
|
34.38 units on a scale
Standard Deviation 28.72
|
50.83 units on a scale
Standard Deviation 32.00
|
Adverse Events
Repetitive Task Practice (RTP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Voluntary Cycling + RTP
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Assisted Cycling + RTP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Repetitive Task Practice (RTP)
n=6 participants at risk
This group focuses on RTP.
Repetitive Task Practice (RTP): This group will preform arm and hand therapy.
|
Voluntary Cycling + RTP
n=8 participants at risk
This group involves one biking session and one RTP session three times per week for eight weeks.
Voluntary cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
Assisted Cycling + RTP
n=6 participants at risk
This group involves one biking session and one RTP session three times per week for eight weeks.
Assisted cycling + RTP: This group will preform arm and hand therapy and cycle on a bike.
|
|---|---|---|---|
|
General disorders
Recurrent stroke
|
0.00%
0/6
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place