Cortical and Biomechanical Dynamics of Ankle Robotics Training in Stroke

NCT01072032 | Completed Results DMC

• 2 other identifiers: A7251-WHP-00043705
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Stroke

Keywords

EEG; Robotics (ankle); Motor-learning; Brain Plasticity

Outcome Measures

Primary Outcomes (1)

• Motor Control

  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)

  3 weeks

Secondary Outcomes (2)

• Functional Walking Measures

  3 weeks

• EEG Spectral Coherence Estimates

  3 weeks

Study Arms (2)

Low-Reward

EXPERIMENTAL

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)

High-Reward

ACTIVE COMPARATOR

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)

Interventions

Anklebot (Ankle Robot) DEVICE

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; Low-Reward

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-)

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Maryland: collaborator

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Goodman RN, Rietschel JC, Roy A, Jung BC, Diaz J, Macko RF, Forrester LW. Increased reward in ankle robotics training enhances motor control and cortical efficiency in stroke. J Rehabil Res Dev. 2014;51(2):213-27. doi: 10.1682/JRRD.2013.02.0050.

  PMID: 24933720 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Ron Goodman
• Organization: Baltimore Veterans Affairs

ronald.goodman@va.gov

410-605-7000

Study Officials

• Ronald N Goodman, PhD

  VA Maryland Health Care System, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 19, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 30, 2016
• Results First Posted: June 30, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)