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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01656876
The Effects of Mirror Therapy on Upper Extremity in Stroke Patients
3 de noviembre de 2015 actualizado por: Taipei Medical University Hospital
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
55% to 75% of people after stroke have a paretic arm that causes motor impairment.
Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost.
MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere.
However, the benefits in certain aspects of outcomes are under debate.
Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed.
In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability.
The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT.
Adding MG to MT might augment the cortical reorganization.
In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
60
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
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New Taipei City, Taiwán, 23561
- Shuang-Ho Hospital, Taipei Medical University
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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
20 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- The onset duration more than 3 months
- Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
- No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
- No serious visual and visual-perception impairments
- No concurrent participation in other drug or rehabilitation research
- No serious attention deficits
- No excessive spasticity in any of the joints of the affected UL exclusion criteria
Exclusion Criteria:
- Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation
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: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Mirror therapy
mirror box training with or without sham mesh glove stimulation
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This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Otros nombres:
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Experimental: Mirror therapy + Mesh glove stimulation
Mirror therapy combined with mesh glove stimulation
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This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session.
The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks.
MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Otros nombres:
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
Otros nombres:
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Comparador activo: Controlled intervention
conventional interventions
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Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Fugl-Meyer Assessment (FMA)
Periodo de tiempo: Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
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The upper-extremity subscale of the FMA contains 33 items to assess motor impairment.
Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).
The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
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Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
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Wolf Motor Function Test (WMFT)
Periodo de tiempo: Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
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Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
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Accelerometers
Periodo de tiempo: Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
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The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory.
Acceleration is sampled at 10 Hz and summed over a user- specified epoch.
The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.
A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
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Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
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revised Nottingham Sensory Assessment (rNSA)
Periodo de tiempo: Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
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The rNSA examines the sensory function of the affected arm and includes tactile sensation (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
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Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Kinematic analyses
Periodo de tiempo: Baseline, change from baseline in kinematic parameters at 4 weeks
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A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used.
The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
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Baseline, change from baseline in kinematic parameters at 4 weeks
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Motor Activity Log (MAL)
Periodo de tiempo: Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
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The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale.
Higher scores indicate superior amount and quality of use in affected upper extremity.
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Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
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Semmes-Weinstein monofilaments
Periodo de tiempo: Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
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The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
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Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
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Functional Independence Measure (FIM)
Periodo de tiempo: Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
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The FIM consists of 18 items grouped into 6 subscales.
Each item is rated from 1 to 7 (max.
score 126) based on the required level of assistance to perform the tasks.
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Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
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Stroke Impact Scale version 3.0 (SIS 3.0)
Periodo de tiempo: Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
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The SIS is a stroke-specific instrument of health related quality of life and contains 59 items measuring 8 domains.
Items are rated on a 5- point Likert scale with lower scores indicate greater difficulty in task completion during the past week.
Aggregate scores, ranges from 0 to 100, are generated for each domain.
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Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
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8-OHdG
Periodo de tiempo: Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
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Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage.About 10 mL to 15 mL urine samples of the patients will be collected in the centrifugal tubes before and after rehabilitation interventions.
The samples will be transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis.
A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), will be used to determine the urinary 8-OHdG levels.
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Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Keh-chung Lin, ScD, School of Occupational Therapy, College of Medicine, National Taiwan University
- Investigador principal: Tsan-hon Liou, PhD, Shuang-Ho Hospital, Taipei Medical University
- Investigador principal: Ching-yi Wu, ScD, Department of Occupational Therapy, College of Medicine, Chang Gung University
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
1 de septiembre de 2010
Finalización primaria (Actual)
1 de mayo de 2014
Finalización del estudio (Actual)
1 de mayo de 2014
Fechas de registro del estudio
Enviado por primera vez
27 de julio de 2012
Primero enviado que cumplió con los criterios de control de calidad
2 de agosto de 2012
Publicado por primera vez (Estimar)
3 de agosto de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
3 de noviembre de 2015
Última verificación
1 de noviembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRC-09-10-08
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. .
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