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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02483676
Ankle Robot to Reduce Foot Drop in Stroke
Adaptive Ankle Robot Control System to Reduce Foot-drop in Chronic Stroke
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Treadmill+anklebot
This group will receive gait training on a treadmill while wearing the anklebot with the adaptive control system.
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This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
Otros nombres:
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Comparador activo: Treadmill only
This group will receive gait training on a treadmill, without use of the anklebot.
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This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Gait Velocity During Self-selected Overground Walking
Periodo de tiempo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Gait velocity during self-selected overground walking measured in cm/sec
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Anterior-posterior Propulsion Forces of Paretic Side During Gait
Periodo de tiempo: Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Newtons: anterior-posterior force generated during push-off phase of the gait cycle
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Change from baseline to: Post 6-weeks training, 6 weeks after completion, and 3 (or 6) months
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Peak Dorsiflexion Angle During Swing Phase of Gait
Periodo de tiempo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Degrees; extent of ankle dorsiflexion to enable foot clearance
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months after completion
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Postural Sway Areas During Quiet Standing
Periodo de tiempo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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cm^2; extent of postural deviations to assess static postural control
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Asymmetric Loading in Quiet Standing
Periodo de tiempo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Ratio of Newtons of force per each leg (paretic/nonparetic) while standing quietly
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Peak Paretic Push Off Forces During Gait Initiation
Periodo de tiempo: Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Newtons; magnitude of forward ground reaction forces
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Change from baseline to: Post 6-week training, 6 weeks after completion, and 3 (or 6) months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Steven J Kittner, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Trastornos cerebrovasculares
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades Neuromusculares
- Mononeuropatías
- Enfermedades del Sistema Nervioso Periférico
- Carrera
- Neuropatías peroneas
Otros números de identificación del estudio
- N1699-R
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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