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Ankle Robotics for Error Augmentation After Stroke

31 de agosto de 2026 actualizado por: Kelly Westlake, University of Maryland, Baltimore

The goal of this pilot clinical trial is to test whether training with a portable ankle robot improves ankle push-off and walking speed in adults with chronic stroke who have ankle weakness. The study will also evaluate whether the device is safe and practical to use during walking rehabilitation.

The main questions it aims to answer are:

Does training with the portable ankle robot improve paretic ankle propulsion during walking? Does training with the portable ankle robot improve walking speed at self-selected and fast walking speeds?

Participants will:

Complete 30 training sessions of treadmill and overground walking while wearing the portable ankle robot, 3 to 4 times per week over 8 to 9 weeks Complete walking and movement assessments before training, after 15 sessions, and after 30 sessions Walk at self-selected and fast speeds while researchers measure ankle propulsion, gait symmetry, and walking speed

Descripción general del estudio

Estado

Inscripción por invitación

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a single-arm pilot study evaluating robotic error augmentation of paretic ankle propulsion during gait training in adults with chronic stroke. Ten participants with chronic (>6 months) stroke and residual ankle weakness will complete 30 training sessions using the AMBLE portable ankle exoskeleton. Assessments are conducted at baseline, after 15 sessions, and after 30 sessions. The hypothesis is that 30 sessions of robot-assisted treadmill gait training enhances paretic ankle plantarflexion propulsive torque and gait symmetry.

Approximately half of stroke survivors are left with chronic mobility disability, typically involving ankle weakness that impairs walking and increases fall risk. Current care relies on ankle-foot orthoses, functional electrical stimulation, canes, and walkers, none of which address the underlying deficit in ankle motor control. Weakness of the paretic plantarflexors limits push-off during late stance, reducing forward propulsion and contributing to reduced walking speed and gait asymmetry.

The investigators previously developed the AMBLE, a lightweight portable ankle exoskeleton that uses impedance-based control with real-time gait event detection to deliver torque synchronized to specific phases of the gait cycle. Prior work by this group using laboratory-based and portable ankle robotics targeted dorsiflexion, demonstrating reduced foot drop and improved overground walking in both early and chronic stroke, and the present study extends an ongoing investigation of the device (NCT04594837). Paretic plantarflexion propulsion has not previously been targeted with the AMBLE. Recent engineering modifications enable graded resistance during the push-off phase of gait, permitting investigation of whether error augmentation applied to paretic ankle propulsion can enhance forward propulsion during walking.

Training sessions consists of two 10-minute bouts of treadmill walking at progressively increasing speed and one 10-minute bout of overground walking as able, with the robot donned on the paretic leg. Plantarflexion resistance is delivered through the ankle robot and calibrated individually, increased as tolerated up to the level just below the point at which hip circumduction or instability emerges. Resistance is applied after attainment of steady-state walking speed and intermittently removed at predetermined intervals to sample voluntary paretic ankle power. Treadmill speed is then progressed toward a target of 70-85% heart rate reserve and RPE 15-18, recorded every 3-5 minutes. Seated rest of 2-3 minutes is provided between bouts.

Visual feedback of ankle propulsion power is delivered through a tablet-based application on a faded schedule: continuously during weeks 1-2, for 1 minute every 5 minutes during weeks 3-4, for 1 minute at the end of each 10-minute bout during weeks 5-6, and as terminal summary feedback during seated rest in weeks 7-9.

Assessments include the 10-meter walk test at self-selected and fastest comfortable speeds; overground gait biomechanics using an instrumented walkway for spatiotemporal parameters and gait symmetry and two force plates for propulsive torque during push-off; and paretic and non-paretic ankle power normalized to body mass with kinetic symmetry, collected during unassisted walking with the device in evaluation mode. The Fugl-Meyer Assessment for the Lower Extremity is administered at baseline. Baseline and post-training measures will be compared using paired t-tests or nonparametric equivalents. Findings will provide preliminary effect estimates to inform the design of a larger trial.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

10

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Allied Health Research Building
      • Baltimore, Maryland, Estados Unidos, 21042
        • Allied Health Research Building

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Chronic stroke, more than 6 months post-stroke
  • Clinical evidence of hemiparetic gait
  • Ankle dorsiflexion and plantarflexion strength on the affected side graded 1/5 (trace contraction) to 4/5 (reduced strength) on manual muscle testing
  • Able to independently complete the 10-Meter Walk Test at a walking speed less than 1.0 m/s, with or without an assistive device

Exclusion Criteria:

  • Self-reported unstable angina, myocardial infarction within the past 3 months, congestive heart failure (NYHA Class II), or hemodynamically significant valvular disease
  • Self-reported hypertension that is a contraindication to routine physical therapy (greater than 160/100 mmHg on two assessments)
  • Self-reported hospitalization within the past 3 months for severe medical illness
  • Self-reported symptomatic peripheral arterial occlusive disease
  • Self-reported orthopedic conditions or chronic pain that significantly alter gait function
  • Self-reported pulmonary or renal failure
  • Self-reported active cancer
  • Self-reported history of a non-stroke neuromuscular disorder restricting gait
  • Aphasia or cognitive functioning that confounds participation, defined as unable to follow two-step commands or by judgment of the evaluating therapist
  • Self-reported history of cerebellar stroke or observable cerebellar signs
  • Self-reported botulinum toxin prescribed for the lower extremities within the previous 3 months

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: AMBLE Robotic Gait Training
Participants with chronic stroke will receive a 30-session gait training program using the AMBLE portable robotic ankle exoskeleton. Training will include treadmill and overground walking with individualized robotic resistance to improve ankle plantarflexion during push-off. Robotic assistance will be adjusted throughout the intervention based on participant performance and tolerance to promote active motor recovery and improve walking function.
The AMBLE is a portable robotic ankle exoskeleton designed to provide individualized assistance and/or resistance during gait training. The device uses adaptive impedance-based control and real-time gait detection to provide dorsiflexion assistance during swing and plantarflexion assistance or resistance during push-off based on participant performance. It is used during treadmill and overground walking to promote recovery of ankle motor control and walking function.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Peak ankle plantarflexion propulsive torque during walking
Periodo de tiempo: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 sessions), and 10 weeks after intervention initiation (following approximately 30 sessions)
Peak ankle plantarflexion propulsive torque will be measured using force plates during overground walking to quantify propulsion generated by the paretic limb during the push-off phase of gait.
Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 sessions), and 10 weeks after intervention initiation (following approximately 30 sessions)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Self-selected walking speed
Periodo de tiempo: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Self-selected walking speed will be assessed using the 10-Meter Walk Test and reported in meters per second.
Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Fast walking speed
Periodo de tiempo: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Maximum comfortable walking speed will be assessed using the 10-Meter Walk Test and reported in meters per second.
Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Step Length Symmetry Ratio During Overground Walking Measured by Instrumented Walkway
Periodo de tiempo: Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)
Step length symmetry ratio computed as paretic step length divided by non-paretic step length from spatiotemporal data collected during overground walking on a GAITRite instrumented walkway. A ratio of 1.0 indicates perfect symmetry between limbs; values below 1.0 indicate shorter paretic steps and values above 1.0 indicate longer paretic steps. Values are averaged across [N] walkway passes at self-selected walking speed at each assessment timepoint. Unit of Measure: ratio
Baseline (prior to intervention), 5 weeks after intervention initiation (following approximately 15 training sessions), and 10 weeks after intervention initiation (following approximately 30 training sessions)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Kelly Westlake, PhD, PT, University of Maryland, Baltimore

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de junio de 2025

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

17 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de agosto de 2026

Publicado por primera vez (Actual)

4 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • HP-00108406

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .