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

This study has been completed.
Sponsor:
Collaborator:
University of Maryland
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01072032
First received: February 17, 2010
Last updated: May 23, 2016
Last verified: May 2016
Results First Received: April 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Cerebral Stroke
Intervention: Device: Anklebot (Ankle Robot)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Low-Reward   High-Reward
STARTED   13   14 
COMPLETED   5   5 
NOT COMPLETED   8   9 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
    Low-Reward   High-Reward   Total
Overall Participants Analyzed 
[Units: Participants]
 13   14   27 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   7   5   12 
>=65 years   6   9   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.3  (4.3)   59.2  (5.4)   60.5  (4.8) 
Gender 
[Units: Participants]
     
Female   8   9   17 
Male   5   5   10 
Region of Enrollment 
[Units: Participants]
     
United States   13   14   27 


  Outcome Measures
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1.  Primary:   Motor Control   [ Time Frame: 3 weeks ]

2.  Secondary:   Functional Walking Measures   [ Time Frame: 3 weeks ]

3.  Secondary:   EEG Spectral Coherence Estimates   [ Time Frame: 3 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: ronald.goodman@va.gov


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 )
Study First Received: February 17, 2010
Results First Received: April 12, 2016
Last Updated: May 23, 2016
Health Authority: United States: Federal Government