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Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke (AbotMot)

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ClinicalTrials.gov Identifier: NCT01072032
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : June 30, 2016
Last Update Posted : June 30, 2016
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cerebral Stroke
Intervention Device: Anklebot (Ankle Robot)
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low-Reward High-Reward
Hide Arm/Group Description

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 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

Period Title: Overall Study
Started 13 14
Completed 5 5
Not Completed 8 9
Arm/Group Title Low-Reward High-Reward Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  53.8%
5
  35.7%
12
  44.4%
>=65 years
6
  46.2%
9
  64.3%
15
  55.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 27 participants
62.3  (4.3) 59.2  (5.4) 60.5  (4.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
8
  61.5%
9
  64.3%
17
  63.0%
Male
5
  38.5%
5
  35.7%
10
  37.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants 14 participants 27 participants
13 14 27
1.Primary Outcome
Title Motor Control
Hide Description 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)
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Reward High-Reward
Hide Arm/Group Description:

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 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.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: 1/s^2
413.22  (140.67) 523.94  (152.02)
2.Secondary Outcome
Title Functional Walking Measures
Hide Description Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Reward High-Reward
Hide Arm/Group Description:
Low-Reward Anklebot training Group: 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 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.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: cm/s
89.45  (45.95) 78.86  (40.06)
3.Secondary Outcome
Title EEG Spectral Coherence Estimates
Hide Description 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.
Time Frame 3 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low-Reward High-Reward
Hide Arm/Group Description:
Low-Reward Anklebot training Group: 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 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.
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Coherence ratio
.35  (.08) .55  (.067)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Low-Reward High-Reward
Hide Arm/Group Description

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 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

All-Cause Mortality
Low-Reward High-Reward
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low-Reward High-Reward
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/13 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low-Reward High-Reward
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/13 (15.38%)      2/14 (14.29%)    
Gastrointestinal disorders     
Colitis * [1]  0/13 (0.00%)  0 1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders     
Hip soreness * [2]  1/13 (7.69%)  1 0/14 (0.00%)  0
Nervous system disorders     
Fall at home * [3]  1/13 (7.69%)  1 1/14 (7.14%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Not study related. Participant placed on medical hold until cleared by physician.
[2]
Participant complained of hip pain after early walking sessions. Withdrew from study due to other medical problems not study-related.
[3]
Two participants fell during course of normal home life. These were deemed not to be study-related by Data Safety Monitoring Board
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Ron Goodman
Organization: Baltimore Veterans Affairs
Phone: 410-605-7000
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01072032     History of Changes
Other Study ID Numbers: A7251-W
HP-00043705 ( Other Identifier: University of Maryland, Baltimore, IRB )
First Submitted: February 17, 2010
First Posted: February 19, 2010
Results First Submitted: April 12, 2016
Results First Posted: June 30, 2016
Last Update Posted: June 30, 2016