Trial Outcomes & Findings for Facilitating Implicit Learning to Improve Neurorehabilitation in Stroke (NCT NCT02017574)

Results Overview

Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

2 Years

Results posted on

2017-03-28

Participant Flow

Participant milestones

Participant milestones
Measure	Implicit Group Receives little feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments	Control Receives detailed feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Facilitating Implicit Learning to Improve Neurorehabilitation in Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implicit Group n=12 Participants Receives little feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments	Control n=12 Participants Receives detailed feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments	Total n=24 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	9 Participants n=93 Participants	8 Participants n=4 Participants	17 Participants n=27 Participants
Age, Categorical >=65 years	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Age, Continuous	60.8 years STANDARD_DEVIATION 11.1 • n=93 Participants	60.7 years STANDARD_DEVIATION 7.2 • n=4 Participants	60.7 years STANDARD_DEVIATION 9.2 • n=27 Participants
Sex: Female, Male Female	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	10 Participants n=4 Participants	18 Participants n=27 Participants
Region of Enrollment United States	12 Participants n=93 Participants	12 Participants n=4 Participants	24 Participants n=27 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.

Quality of motor behavior was indexed by the percentage of samples in which the participants were within the trained (i.e. optimal) trajectory. The trained trajectory was a 2cm wide channel in the shape of a half circle between two targets which were 25cm apart from each other. Therefore, the scale measure is a percentage which can range between 0 and 100%.

Outcome measures

Outcome measures
Measure	Implicit Group n=10 Participants Receives little feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments	Control n=10 Participants Receives detailed feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments
Quality of Motor Performance	.49 percentage of samples not 'on' task Standard Deviation .169	.67 percentage of samples not 'on' task Standard Deviation .17

SECONDARY outcome

Timeframe: 2 Years

Population: Of the 24 participants recruited , 4 were excluded from the analysis due to poor data quality.

Brain electrophysiology measure of attentional processes as indexed by high alpha power (10-13 Hz). The unit of measurement is a percentage as the amount of power (microvolts squared) in the high alpha band was divided by the total power in the spectrum (i.e. 1-50 Hz). This method is commonly employed to normalize the power of a particular frequency if the statistical design includes a between subjects factor.

Outcome measures

Outcome measures
Measure	Implicit Group n=10 Participants Receives little feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments	Control n=10 Participants Receives detailed feedback about task performance during learning Reaching Task: Learn a reaching task that requires coordination of the arm segments
EEG Derived High Alpha Power	.089 percentage of the total power Standard Error .007	.086 percentage of the total power Standard Error .008

Adverse Events

Implicit Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeremy Rietschel, PhD

Baltimore Veterans Affairs

Phone: 410-605-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place