- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03194464
Fatiguing Arm Exercise Following Stroke
Neural Mechanisms Mediating Interlimb Transfer Following Stroke
Descripción general del estudio
Descripción detallada
The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand.
The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis:
- . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.
- . Behavioral effects using a motor task involving manipulation and dexterity.
- . Determine the persistence and consistency of neural and behavioral facilitation.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Gainesville, Florida, Estados Unidos, 32608
- North Florida/South Georgia Veterans Health System, Gainesville, FL
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
- Non-Veteran Participants are eligible
Exclusion Criteria:
- multiple strokes
- strokes in both hemispheres
- brainstem/medullary/cerebellar stroke
- seizure disorder
- metal implants in head or neck
- pacemaker or other implanted device
- inability to produce any measurable grip force
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Task-failure, Extended Session
Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period
|
participants perform repeated gripping with visual feedback to task failure
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Short Intracortical Inhibition (SICI)
Periodo de tiempo: baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
|
baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
SICI Ratio
Periodo de tiempo: Baseline, pre-exercise of 8 repeated sessions
|
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure.
SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation.
In health, SICI is ~0.5.
Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health.
Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
|
Baseline, pre-exercise of 8 repeated sessions
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Box and Blocks Test (BBT)
Periodo de tiempo: baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
|
baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
|
Box and Blocks Test (BBT)
Periodo de tiempo: baseline, pre-exercise of 8 repeated sessions
|
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute.
Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure.
Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve.
Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
|
baseline, pre-exercise of 8 repeated sessions
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Carolynn Patten, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL
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 (Actual)
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
Otros números de identificación del estudio
- N1759-P
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.
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. .
Ensayos clínicos sobre submaximal exercise (grip)
-
University of South FloridaFlorida High Tech Corridor Council; TRS, Inc.TerminadoAmputación de miembro superiorEstados Unidos
-
Teresa Moreno CasbasFondo de Investigacion SanitariaTerminado
-
Assistance Publique - Hôpitaux de ParisTerminadoFijación del cráneo después de una craneotomía para procedimientos neuroquirúrgicosFrancia
-
Rahul AggarwalNational Cancer Institute (NCI); U.S. Army Medical Research Acquisition ActivityReclutamientoCancer de prostata | Tumor sólido avanzado | Cáncer renal | Cáncer de uretra | Tumor Sólido, Adulto | Cáncer de próstata metastásico resistente a la castraciónEstados Unidos
-
Istituto Ortopedico RizzoliTerminado
-
Mayo ClinicDepartment of Health and Human ServicesTerminado