Trial Outcomes & Findings for Learning in Stroke (NCT NCT05511467)
NCT ID: NCT05511467
Last Updated: 2025-10-20
Results Overview
Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction. Precision of force adjustment is based on the recorded muscle force monitored during task performance and defined as the actual force exerted by the participant relative to the target force (measurement unit: precision in %), with positive values indicating over- and negative values indicating undershoot. Learning rate from before to after learning will be defined as the difference in precision between before as compared to after one single learning session. Precision error was calculated as the percentage deviation of the actual grip force from the target force, averaged across trials before and after the learning task. A reduction in force error indexes a behavioral advantage of force adjustment over time and is thus interpreted as learning.
COMPLETED
40 participants
Pre Learning Session and Post Learning Session (approximately 90 minutes)
2025-10-20
Participant Flow
Recruitment period 09/01/2022 - 03/30/2024
Participant milestones
| Measure |
stroke group
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
control group
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
15
|
|
Overall Study
COMPLETED
|
24
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Learning in Stroke
Baseline characteristics by cohort
| Measure |
stroke group
n=25 Participants
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
control group
n=15 Participants
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
60 years
n=107 Participants
|
59.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Pre Learning Session and Post Learning Session (approximately 90 minutes)Population: One stroke group participant was excluded because of poor data quality (excessive movement inside the MRI). One control group participant excluded due to incidental findings.
Isometric whole-hand grip force is captured continuously with grip-force transducers (at 1000Hz) and adjusted relative to the individual maximum voluntary contraction. Precision of force adjustment is based on the recorded muscle force monitored during task performance and defined as the actual force exerted by the participant relative to the target force (measurement unit: precision in %), with positive values indicating over- and negative values indicating undershoot. Learning rate from before to after learning will be defined as the difference in precision between before as compared to after one single learning session. Precision error was calculated as the percentage deviation of the actual grip force from the target force, averaged across trials before and after the learning task. A reduction in force error indexes a behavioral advantage of force adjustment over time and is thus interpreted as learning.
Outcome measures
| Measure |
stroke group
n=24 Participants
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
control group
n=14 Participants
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
|---|---|---|
|
Learning Rate as Indexed by Change in the Precision of Visuomotor Grip Force Adjustment (i.e., Reduction of Precision Error in Force Adjustment)
|
-1.48 Percentage deviation from target force
Interval -72.6 to 45.9
|
0.303 Percentage deviation from target force
Interval -16.9 to 12.4
|
PRIMARY outcome
Timeframe: Pre Learning Session and Post Learning Session (approximately 90 minutes)Population: One stroke group participant was excluded because of poor data quality (excessive movement inside the MRI). One control group participant excluded due to incidental findings.
Learning-related BOLD-signal-derived brain activation relative to motor performance.
Outcome measures
| Measure |
stroke group
n=24 Participants
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
control group
n=14 Participants
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
|---|---|---|
|
Change in Blood-oxygen-level-dependent (BOLD) Signal Derived Multi-voxel Brain Activation
|
2.6 percentage of BOLD signal change
Interval 1.1 to 4.2
|
3.25 percentage of BOLD signal change
Interval 1.8 to 4.75
|
Adverse Events
stroke group
control group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
stroke group
n=25 participants at risk
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
control group
n=15 participants at risk
Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'.
|
|---|---|---|
|
Nervous system disorders
Incidental finding during MRI
|
0.00%
0/25 • Adverse event data was collected for the duration of the experimental procedures (approximately 4 individual visits within 2 consecutive weeks).
Adverse events were defined as unexpected events during experimental procedures, specifically including magnetic resonance imaging (MRI), related or unrelated to experimental procedures.
|
6.7%
1/15 • Number of events 1 • Adverse event data was collected for the duration of the experimental procedures (approximately 4 individual visits within 2 consecutive weeks).
Adverse events were defined as unexpected events during experimental procedures, specifically including magnetic resonance imaging (MRI), related or unrelated to experimental procedures.
|
Additional Information
Principal Investigator
Medical University of South Carolina
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place