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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

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.

Condition or disease Intervention/treatment Phase
Stroke Foot Drop Device: Treadmill plus anklebot Behavioral: Treadmill only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Actual Study Start Date : September 1, 2015
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Treadmill+anklebot
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
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

Active Comparator: Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
Behavioral: Treadmill only
This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Other Name: TM




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483676


Locations
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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
Investigators
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Principal Investigator: Steven J Kittner Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
  Study Documents (Full-Text)

Documents provided by VA Office of Research and Development:
Statistical Analysis Plan  [PDF] April 12, 2019
Informed Consent Form  [PDF] January 17, 2019
Study Protocol  [PDF] May 27, 2015

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02483676    
Other Study ID Numbers: N1699-R
First Posted: June 29, 2015    Key Record Dates
Results First Posted: May 20, 2020
Last Update Posted: May 20, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Rehabilitation
Robotics
Gait
Additional relevant MeSH terms:
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Stroke
Peroneal Neuropathies
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases