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
  Purpose

Reduced mobility is often a long-term problem facing those who have chronic leg weakness resulting from stroke. Recent innovations in stroke therapy have applied motor learning principles to improve motor skills through regular practice of activities using the weaker limb. Because the ankle provides critical torques for normal walking and mobility function, impairments at the affected ankle pose a major limitation to achieving optimal mobility recovery. To address this we have developed a novel ankle robot (Anklebot) to enhance physical therapy for improving walking and mobility after stroke. This computer controlled device provides assistance when users cannot complete a movement, but will not assist if the user is active.

Motor learning requires active involvement in task-related practice to mediate brain plasticity. While voluntary movement is important to remodel motor control circuits, the brain mechanisms of reward and motivation also can play an important role. Core brain networks involved in reward and motivation increase a person's involvement with their surroundings, to focus attention and to prompt one to approach reward and avoid punishment. This increased involvement and the elevated emotions associated with it have been shown to enhance performance, memory and learning.

The purpose of this study is to investigate responses of brain and motor behavior of stroke patients who use the Anklebot during a 3-week / 3-session/week motor learning based training. These responses are compared to a 3-week delayed entry period in which the participants will perform an at-home walking program of equal time. After the 3-week delayed entry walking program, subjects are divided into low and high reward-feedback groups. 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 researchers. The high-reward group receives cumulative scores and ongoing social support, are eligible for prizes during each session and at the study's completion. All subjects play the games as noninvasive electroencephalography and electromyography record brain and muscle activity. In addition to analyzing brain information before and after the Anklebot training, ankle motor control and walking functions are also assessed immediately before and after the first and last robotic training sessions.


Condition Intervention
Cerebral Stroke
Device: Anklebot (Ankle Robot)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Motor Control [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Functional Walking Measures [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Preferred, self-selected walking velocity measured in centimeters/second (i.e., cm/s).

  • EEG Spectral Coherence Estimates [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 27
Study Start Date: May 2010
Study Completion Date: September 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low-Reward
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.
Device: 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
Active Comparator: High-Reward
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
Device: 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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke greater than 3 months prior
  • Residual hemiparetic gait with observable asymmetry in the gait pattern.
  • Women or men aged 21 to 85 years
  • Completed all conventional physical therapy.
  • Adequate language and neurocognitive function to participate in training, testing, and to give informed consent.
  • Minimal ankle flexion in either direction (dorsi- or plantar-)

Exclusion Criteria:

  • MMSE score < 23 (9th grade education or more) or MMSE score < 17 (8th grade education or less)
  • CES-D score > 16
  • Clinical history of orthopedic, chronic pain or severe neuromuscular disorders restricting participation in a short term ankle movement training paradigm.
  • Severe or global receptive aphasia which confounds reliable testing and training.
  • Women of child-bearing potential, if there is any self-reported chance that they may be pregnant.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072032

Locations
United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
University of Maryland
Investigators
Principal Investigator: Ronald N Goodman, PhD VA Maryland Health Care System, Baltimore
  More Information

Additional Information:
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 
Study First Received: February 17, 2010
Results First Received: April 12, 2016
Last Updated: May 23, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by VA Office of Research and Development:
EEG
Robotics (ankle)
Motor-learning
Brain Plasticity

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 26, 2016