Ankle Robot to Reduce Foot Drop in Stroke
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/9/2019 |
| Start Date: | September 1, 2015 |
| End Date: | June 30, 2019 |
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic 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.
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.
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, 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.
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, 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.
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
We found this trial at
1
site
Baltimore, Maryland 21201
Phone: 410-605-7000
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