Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ankle Robot to Reduce Foot Drop in Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02483676
Recruitment Status : Completed
First Posted : June 29, 2015
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE June 19, 2015
First Posted Date  ICMJE June 29, 2015
Results First Submitted Date  ICMJE April 23, 2020
Results First Posted Date  ICMJE May 20, 2020
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE September 1, 2015
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2020)
  • Gait Velocity During Self-selected Overground Walking [ Time Frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion ]
    Gait velocity during self-selected overground walking measured in cm/sec
  • Anterior-posterior Propulsion Forces of Paretic Side During Gait [ Time Frame: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months ]
    Newtons: anterior-posterior force generated during push-off phase of the gait cycle
  • Peak Dorsiflexion Angle During Swing Phase of Gait [ Time Frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion ]
    Degrees; extent of ankle dorsiflexion to enable foot clearance
  • Postural Sway Areas During Quiet Standing [ Time Frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months ]
    cm^2; extent of postural deviations to assess static postural control
  • Ratio of Asymmetric Loading in Quiet Standing [ Time Frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months ]
    Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
  • Peak Paretic Push Off Forces During Gait Initiation [ Time Frame: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months ]
    Newtons; magnitude of forward ground reaction forces
Original Primary Outcome Measures  ICMJE
 (submitted: June 24, 2015)
  • Gait velocity during self-selected overground walking [ Time Frame: change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
    cm/sec
  • Anterior-posterior propulsion forces of paretic side during gait [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
    Newtons; force generated during push-off phase of the gait cycle
  • Peak dorsiflexion angle during swing phase of gait [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
    degrees; extent of ankle dorsiflexion to enable foot clearance
  • Postural sway areas during quiet standing [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
    cm^2; extent of postural deviations to assess static postural control
  • Ratio of asymmetric loading in quiet standing [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
    ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
  • Peak paretic push off forces during gait initiation [ Time Frame: Change from baseline to: post 6 weeks training, 6 weeks after completion of training, and 6 months after completion of training ]
    Newtons; magnitude of forward ground reaction forces.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ankle Robot to Reduce Foot Drop in Stroke
Official Title  ICMJE Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Brief Summary Deficits in ankle control after stroke can lead to foot drop, resulting in inefficient, aberrant gait and an elevated falls risk. Using a novel ankle robot and newly invented adaptive control system, this study tests whether robotic-assisted treadmill training will improve gait and balance functions in chronic stroke survivors with foot drop impairment. It is hypothesized that, compared to treadmill training alone, integrating adaptive ankle robotics with treadmill training will reduce drop foot during independent overground walking, resulting in greater mobility, improved postural control, and reduced fall risk.
Detailed Description

This proposal investigates a novel ankle robot (anklebot) adaptive control approach integrated with treadmill training to reduce foot drop and improve mobility function in chronic hemiparetic stroke survivors. Currently, stroke survivors with foot drop are trained to live with a cane or other assistive device, and often ankle foot orthotics (AFOs) for safety. Neither mediates task-practice or neuromotor recovery.

The investigators have developed an adaptive anklebot controller that detects gait cycle sub-events for precise timing of graded robotics assistance to enable deficit severity-adjusted ankle motor learning in the context of walking. The investigators' pilot findings show that 6 weeks treadmill training with anklebot (TMR) timed to assist swing phase dorsiflexion only is more effective than treadmill alone (TM) to improve free-walking swing dorsiflexion at foot strike, floor-walking speed, and the benefits are retained at 6 weeks post-training. Notably, swing-phase TMR training improved paretic leg push-off, and reduced center-of-pressure sway on standing balance, indicating potential benefits to other elements of gait and balance, beyond those robotically targeted toward foot drop.

This randomized study investigates the hypothesis that 6 weeks TMR is more effective to improve durably gait biomechanics, static, and dynamic balance, and mobility function in chronic stroke survivors with dorsiflexion deficits, compared to TM alone. Aims are to determine the compare effectiveness of 6 weeks TMR vs. TM alone on:

  1. Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
  2. Balance function indexed by measures of postural sway (CoP), asymmetric loading in quiet standing, peak paretic A-P forces in non-paretic gait initiation, and standardized scales for balance and fall risk.
  3. Long-term mobility outcomes, assessed by repeated measures of all key gait and balance outcomes at 6 weeks and 3 months after formal training cessation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke
  • Foot Drop
Intervention  ICMJE
  • Device: Treadmill plus anklebot
    This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
    Other Name: TMR
  • Behavioral: Treadmill only
    This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
    Other Name: TM
Study Arms  ICMJE
  • Experimental: Treadmill+anklebot
    This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
    Intervention: Device: Treadmill plus anklebot
  • Active Comparator: Treadmill only
    This group will receive gait training on a treadmill, without use of the anklebot.
    Intervention: Behavioral: Treadmill only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 8, 2020)
45
Original Estimated Enrollment  ICMJE
 (submitted: June 24, 2015)
72
Actual Study Completion Date  ICMJE June 30, 2019
Actual Primary Completion Date April 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke > 2 months prior in men or women
  • Residual hemiparesis of the lower extremity that includes symptoms of foot drop
  • Capable of ambulating on a treadmill with handrail support
  • Already completed all conventional physical therapy
  • Adequate language and cognitive function to provide informed consent and participate in testing and training

Exclusion Criteria:

  • Cardiac history of:

    • Unstable angina
    • Recent (< 3 months) myocardial infarction
    • Congestive heart failure (NYHA category II or higher)
    • Hemodynamic valvular dysfunction
    • Hypertension that is a contraindication for a bout of treadmill training (>160/100 mmHg on two assessments)
  • Medical history of:

    • Recent hospitalization (< 3 months) for any serious condition leading to significant bed-rest or reduction in mobility function
    • Symptomatic peripheral arterial occlusive disease
    • Orthopedic or chronic pain conditions restricting exercise
    • Pulmonary failure requiring oxygen
    • Uncompensated renal failure
    • Active cancer
  • Neurological history and exam consistent with:

    • Dementia
    • Receptive or global aphasia that confounds testing and training, operationally defined as unable to follow 2-point commands
    • Non-stroke neurological disorder restricting exercise (e.g. Parkinson's Syndrome, myopathy)
    • Untreated major depression
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02483676
Other Study ID Numbers  ICMJE N1699-R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Steven J Kittner Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
PRS Account VA Office of Research and Development
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP