Trial Outcomes & Findings for Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke (NCT NCT01072032)

NCT ID: NCT01072032

Last Updated: 2016-06-30

Results Overview

Normalized jerk is a measure of movement smoothness, derived from jerk \[(meters)/(second cubed)\] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s\^2)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 27 participants
• Primary outcome timeframe: 3 weeks
• Results posted on: 2016-06-30

Participant Flow

Participant milestones

Measure	Low-Reward Low-Reward Anklebot training Group Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery	High-Reward High-Reward Anklebot training Group Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery
Overall Study STARTED	13	14
Overall Study COMPLETED	5	5
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke

Baseline characteristics by cohort

Measure	Low-Reward n=13 Participants Low-Reward Anklebot training Group Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery	High-Reward n=14 Participants High-Reward Anklebot training Group Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery	Total n=27 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
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 4.3 • n=5 Participants	59.2 years STANDARD_DEVIATION 5.4 • n=7 Participants	60.5 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	14 participants n=7 Participants	27 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks

Normalized jerk is a measure of movement smoothness, derived from jerk [(meters)/(second cubed)] divided by the peak velocity (meters/second), leaving values in units of 1/second squared (ie., 1/s^2)

Outcome measures

Measure	Low-Reward n=5 Participants Low-Reward Anklebot training Group Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.	High-Reward n=5 Participants High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
Motor Control	413.22 1/s^2 Standard Deviation 140.67	523.94 1/s^2 Standard Deviation 152.02

SECONDARY outcome

Timeframe: 3 weeks

Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).

Outcome measures

Measure	Low-Reward n=5 Participants Low-Reward Anklebot training Group Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.	High-Reward n=5 Participants High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
Functional Walking Measures	89.45 cm/s Standard Deviation 45.95	78.86 cm/s Standard Deviation 40.06

SECONDARY outcome

Timeframe: 3 weeks

EEG coherence reflects the degree to which brain regions communicate. It is derived from calculating the degree of association between regions in specified frequency bandwidths; it is like a correlation, except that the values range from 0-1 instead of -1 to 1, so technically there are no units as it is a coefficient. Higher coherence values indicate stronger associations between regions.

Outcome measures

Measure	Low-Reward n=5 Participants Low-Reward Anklebot training Group Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.	High-Reward n=5 Participants High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
EEG Spectral Coherence Estimates	.35 Coherence ratio Standard Deviation .08	.55 Coherence ratio Standard Deviation .067

Adverse Events

Low-Reward

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

High-Reward

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Low-Reward n=13 participants at risk Low-Reward Anklebot training Group Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery	High-Reward n=14 participants at risk High-Reward Anklebot training Group Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery
Nervous system disorders Fall at home	7.7% 1/13 • Number of events 1 • During the period of active enrollment in the study, covering initial intake screening, followed by 3 weeks of activity and post-testing: total 4-5 weeks.	7.1% 1/14 • Number of events 1 • During the period of active enrollment in the study, covering initial intake screening, followed by 3 weeks of activity and post-testing: total 4-5 weeks.
Gastrointestinal disorders Colitis	0.00% 0/13 • During the period of active enrollment in the study, covering initial intake screening, followed by 3 weeks of activity and post-testing: total 4-5 weeks.	7.1% 1/14 • Number of events 1 • During the period of active enrollment in the study, covering initial intake screening, followed by 3 weeks of activity and post-testing: total 4-5 weeks.
Musculoskeletal and connective tissue disorders Hip soreness	7.7% 1/13 • Number of events 1 • During the period of active enrollment in the study, covering initial intake screening, followed by 3 weeks of activity and post-testing: total 4-5 weeks.	0.00% 0/14 • During the period of active enrollment in the study, covering initial intake screening, followed by 3 weeks of activity and post-testing: total 4-5 weeks.

Additional Information

Dr. Ron Goodman

Baltimore Veterans Affairs

Phone: 410-605-7000

Email: ronald.goodman@va.gov

Results disclosure agreements

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