Ankle Robot to Reduce Foot-drop in Stroke

Recruiting

Phase N/A Results N/A

Update History

29 Sep '17
The Summary of Purpose was updated.
New
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.
Old
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.
The description was updated.
New
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 investigator's 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.
Old
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 investigator's 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.
The eligibility criteria were updated.
New
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 & 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 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
Old
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 & 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 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
29 Apr '17
Trial was updated to "N/A."
28 Apr '17
The Summary of Purpose was updated.
New
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.
Old
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.
The description was updated.
New
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 investigator's 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.
Old
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 (AFO's) 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 assist to enable deficit severity adjusted ankle motor learning in the context of walking. The investigator's 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 durably improve 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 6 months after formal training cessation.
The gender criteria for eligibility was updated to "All."
The minimum age criteria for eligibility was updated to "18 Years."
The eligibility criteria were updated.
New
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 & 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 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
Old
Inclusion Criteria: - Ischemic or hemorrhagic stroke >6 months prior in men or women ages 40-85 years. - Residual hemiparetic (HP) gait with DF deficit (*see specific criteria, below), minimum intact proprioception 4 mm at paretic proximal inter-phalangeal joint (to minimize major sensory deficit as a covariate in ankle ML). - Capable of ambulating on TM with handrail support for 3 minutes at 0.09 m/s (0.2 MPH) in order to participate in TM, as previously described. - Already completed all conventional physical therapy, and not receiving paretic leg botulinum toxin. - Adequate language & cognitive function to provide informed consent and participate in testing and training. Exclusion Criteria: - Self-selected (10-m) walking velocity >0.8 m/s; excludes community ambulator category (functional ceiling). - Fixed or painful contractures or spasticity defined as 2 pts, Modified Ashworth Scale; marked increase in tone, but still moveable across range of motion at paretic ankle, while on usual medications. - Cardiac history of: - unstable angina - recent (< 3 months) myocardial infarction - congestive heart failure (NYHA category II or higher) - hemodynamic valvular dysfunction. - Medical History: - recent hospitalization (<2 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 - poorly controlled hypertension (>160/100) or diabetes with fasting glucose>160 mg/dl or HbA1C>10% - medical history or exam of known or suspected deep venous thrombosis <3 months. - 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.
4 Dec '15
The description was updated.
New
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 (AFO's) 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 assist to enable deficit severity adjusted ankle motor learning in the context of walking. The investigator's 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 durably improve 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 6 months after formal training cessation.
Old
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 (AFO's) 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 assist to enable deficit severity adjusted ankle motor learning in the context of walking. The investigator's 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 durably improve 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 6 months after formal training cessation.
The eligibility criteria were updated.
New
Inclusion Criteria: - Ischemic or hemorrhagic stroke >6 months prior in men or women ages 40-85 years. - Residual hemiparetic (HP) gait with DF deficit (*see specific criteria, below), minimum intact proprioception 4 mm at paretic proximal inter-phalangeal joint (to minimize major sensory deficit as a covariate in ankle ML). - Capable of ambulating on TM with handrail support for 3 minutes at 0.09 m/s (0.2 MPH) in order to participate in TM, as previously described. - Already completed all conventional physical therapy, and not receiving paretic leg botulinum toxin. - Adequate language & cognitive function to provide informed consent and participate in testing and training. Exclusion Criteria: - Self-selected (10-m) walking velocity >0.8 m/s; excludes community ambulator category (functional ceiling). - Fixed or painful contractures or spasticity defined as 2 pts, Modified Ashworth Scale; marked increase in tone, but still moveable across range of motion at paretic ankle, while on usual medications. - Cardiac history of: - unstable angina - recent (< 3 months) myocardial infarction - congestive heart failure (NYHA category II or higher) - hemodynamic valvular dysfunction. - Medical History: - recent hospitalization (<2 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 - poorly controlled hypertension (>160/100) or diabetes with fasting glucose>160 mg/dl or HbA1C>10% - medical history or exam of known or suspected deep venous thrombosis <3 months. - 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.
Old
Inclusion Criteria: - Ischemic or hemorrhagic stroke >6 months prior in men or women ages 40-85 years. - Residual hemiparetic (HP) gait with DF deficit (*see specific criteria, below), minimum intact proprioception 4 mm at paretic proximal inter-phalangeal joint (to minimize major sensory deficit as a covariate in ankle ML). - Capable of ambulating on TM with handrail support for 3 minutes at 0.09 m/s (0.2 MPH) in order to participate in TM, as previously described. - Already completed all conventional physical therapy, and not receiving paretic leg botulinum toxin. - Adequate language & cognitive function to provide informed consent and participate in testing and training. Exclusion Criteria: - Self-selected (10-m) walking velocity >0.8 m/s; excludes community ambulator category (functional ceiling). - Fixed or painful contractures or spasticity defined as 2 pts, Modified Ashworth Scale; marked increase in tone, but still moveable across range of motion at paretic ankle, while on usual medications. - Cardiac history of: - unstable angina - recent (< 3 months) myocardial infarction - congestive heart failure (NYHA category II or higher) - hemodynamic valvular dysfunction. - Medical History: - recent hospitalization (<2 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 - poorly controlled hypertension (>160/100) or diabetes with fasting glucose>160 mg/dl or HbA1C>10% - medical history or exam of known or suspected deep venous thrombosis <3 months. - 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.
A location was updated in Baltimore.
New
The overall status was updated to "Recruiting" at Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD.