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Completed

NCT Number: NCT02483676

Ankle Robot to Reduce Foot Drop in Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21201, United States

About this study

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:

  • Independent gait function indexed by gait velocity, swing-phase DF (dorsiflexion), terminal stance push-off.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treadmill plus anklebot

Device

This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.

Other names: TMR

Treadmill only

Behavioral

This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period

Other names: TM

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2015
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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