Potential for Recovery of Voluntary Finger Extension After Stroke (PROVES)
Stroke patients with absent voluntary finger extension (VFE) 6-months after stroke are not expected to recover hand function. However, experience from the Queen Square Upper Limb neurorehabilitation service contradicts this view. In this study, we will identify the characteristics of those chronic stroke patients who regain previously absent VFE.
Hundred chronic stroke patients will be recruited with absent/negligible VFE in an external pilot and feasibility study. Transcranial magnetic stimulation will be used to determine the functional integrity of descending white matter pathways. Corticospinal tract integrity to finger extensor muscles will be based on whether motor-evoked potentials are present (MEP+) or absent (MEP-). Reticulospinal tract activity will be assessed by measuring ipsilateral MEP amplitudes and the Start-React response.
All patients will then receive 3-months of neuromuscular electrical stimulation plus home exercise, designed to strengthen wrist/finger extensors, reduce spasticity and increase corticospinal excitability. The primary outcome measure will be restoration of VFE.
It is predicted that VFE will be restored in MEP+ but not MEP- patients. MEP- patients will have higher reticulospinal tract activity associated with spasticity. Restoration of VFE will allow patients to engage in evidence-based upper limb training to improve function e.g. constraint induced movement therapy or repetitive task training.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Professor Nick Ward, MD
- Número de teléfono: +44 20 3448 3486
- Correo electrónico: n.ward@ucl.ac.uk
Copia de seguridad de contactos de estudio
- Nombre: Lisa Tedesco Triccas, PhD
- Correo electrónico: l.triccas@ucl.ac.uk
Ubicaciones de estudio
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London, Reino Unido, WC1N 3BJ
- University College London- Department of Clinical and Movement Neurosciences
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
- Diagnosed with a Stroke >6 months previously
- Medical Research Council (MRC) grade 0 or 1 in long finger extensors.
Exclusion Criteria
- Presence of spasticity in any wrist/finger flexors (including lumbricals) >2 on Modified Ashworth Scale
- Unable to get hand flat on table top
- Botulinum toxin to long finger or wrist flexors < 24 weeks prior to pre-treatment assessment (i.e. effects should have worn off).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Neuromuscular electrical stimulation (NMES) and home exercise programme
Three month intervention programme of Neuromuscular electrical stimulation (NMES) and home exercise programme
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-Neuromuscular and Electrical Stimulation (NMES): All participants will undergo a NMES treatment programme designed to strengthen wrist and finger extensors. Participants and their carers will receive training in NMES set up from the research physiotherapist. Surface electrodes are placed over the motor points of extensor carpi radialis and extensor digitorum communis to produce wrist and finger extension simultaneously. Home exercise: We aim for all patients to perform the Graded Repetitive Arm Supplementary Program (GRASP) level 1 (for severely affected upper limbs) for a minimum of 60 minutes/day, 5 days/week. Patients will be provided with an exercise book containing written and pictorial instructions for each exercise, and the kits contained inexpensive equipment to complete the exercises. Exercises included strengthening of the arm and hand, range of motion, and gross and fine motor skills. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Voluntary Finger Extension (VFE)
Periodo de tiempo: Day 1 and Day 90
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Can participants achieve at least 10° of thumb abduction/extension, and at least 10° of extension in a minimum of 2 additional digits (movements need to be repeatable 3 times in 1 minute).
The extent of VFE will be measured using an electronic goniometer.
Extent of finger extension is calculated for each finger as a composite of extension at metacarpophalangeal, proximal and distal interphalangeal joints.
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Day 1 and Day 90
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Upper Extremity Fugl-Meyer Assessment
Periodo de tiempo: Day 1 and Day 90
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Measurement of upper limb motor recovery after stroke
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Day 1 and Day 90
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Hand Dynamometry
Periodo de tiempo: Day 1 and Day 90
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Measurement of grip strength
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Day 1 and Day 90
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Fugl-Meyer Assessment - Sensory function
Periodo de tiempo: Day 1 and Day 90
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As of part of the Fugl-Meyer Assessment, this measure is used to evaluate somatosensory function of the upper limbs.
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Day 1 and Day 90
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Modified Tardieu Scale (MTS)
Periodo de tiempo: Day 1 and Day 90
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MTS is a clinical tool used to assess spasticity.
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Day 1 and Day 90
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KINARM- Passive Stretch Task
Periodo de tiempo: Day 1 and Day 90
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The KINARM Passive Stretch Task is a quantitative assessment performed with the KINARM robotic assessment system in which the participant's limb is passively displaced by the robot while they are instructed to remain relaxed.
The device applies controlled position- or torque-driven perturbations to one or more joints (typically elbow and/or shoulder) across predefined velocities and ranges of motion.
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Day 1 and Day 90
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Box and Block Test (BBT)
Periodo de tiempo: Day 1 and Day 90
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BBT is a standard assessment to measure manual dexterity and gross motor coordination of the hands.
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Day 1 and Day 90
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Stroke Impact Scale (SIS)
Periodo de tiempo: Day 1 and Day 90
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SIS is a self-reported questionnaire designed to measure the multidimensional impact of stroke on a person's life.
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Day 1 and Day 90
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Neurophysiological- Corticospinal Tract Integrity
Periodo de tiempo: Day 1 and Day 90
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Corticospinal tract integrity is measured using Transcranial Magnetic Stimulation (TMS) to evaluate the functional status of motor pathways in the brain and spinal cord - identified as Motor Evoked Potential Positive (MEP+) or Negative (MEP-).
Resting and Active Motor Threshold will also be measured in addition with the Compound Muscle Action Potential.
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Day 1 and Day 90
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Neurophysiological- Reticulospinal Tract Integrity
Periodo de tiempo: Day 1 and Day 90
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This will be assessed using the Start React Protocol and measurement of ipsilateral Motor Evoked Potentials (iMEPs).
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Day 1 and Day 90
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Neurophysiological- Somatosensory Evoked Potentials
Periodo de tiempo: Day 1 and Day 90
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Median nerve somatosensory evoked potentials will be measured using Electroencephalography (EEG).
The measures will mainly involve recording cortical responses to peripheral nerve stimulation.
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Day 1 and Day 90
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nick Ward, MD, University College, London
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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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
Otros números de identificación del estudio
- 367119
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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