Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke
5 de febrero de 2017 actualizado por: Chang Gung Memorial Hospital
Effects of Home-based Mirror Therapy Combined With Task-oriented Training for Patients With Stroke: a Randomized Controlled Trial
The specific aims of this study will be:
- To compare the immediate and retention treatment effects of the patients receiving home-based mirror therapy combined with task-oriented training (MTOT) with a hospital-based MTOT group and a hospital conventional rehabilitation group on different aspects of outcomes.
- To examine the feasibility, satisfaction, and safety of this novel home-based MTOT program.
- To investigate the factors that may affect the efficacy of home-based stroke rehabilitation.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this 3-year study project, we will design a single-blind randomized controlled trial (1) to compare the treatment effects of home-based MTOT with a hospital-based MTOT group and a hospital conventional rehabilitation group, (2) to investigate the feasibility, satisfaction, and safety of this home-based program, and (3) to identify the factors that might influence treatment outcomes.
An estimated total of 90 patients with stroke will be recruited in this study.
All participants will be randomly assigned to receive home-based MTOT or hospital-based rehabilitation for a 4-week training period (a total of 12 sessions).
Before the first treatment session, a client-centered questionnaire will be administered to each patient for identifying individual needs and goals.
Feasibility evaluation and caregiver's wellbeing will be also assessed.
Outcome measures will be conducted at baseline, immediately after treatment, and 3 months follow-up.
Tipo de estudio
Intervencionista
Inscripción (Actual)
3
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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Kaohsiung, Taiwán
- Kaohsiung Chang Gung Memorial Hospital
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Taipei, Taiwán
- Taipei Chang Gung Memorial Hospital
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Taoyuan, Taiwán
- Taoyuan Chang Gung Memorial Hospital
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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 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- diagnosed as having a unilateral stroke
- at least 3 months after stroke onset
- from 20 to 80 years of age
- having completed acute rehabilitation care or discharged home
- a baseline score of the Fugl-Meyer Assessment (FMA) of 20 to 60
- able to follow the therapy instructions (cognition status will be measured by the Montreal Cognitive Assessment)
- capable of participating in therapy and assessment sessions.
Exclusion Criteria:
- neglect
- global or receptive aphasia
- major medical problems
- comorbidities that influenced UE usage or caused severe pain
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 paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: home-based MTOT
Home-based mirror therapy combined with task-oriented training (MTOT)
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The home-based MTOT group will receive 30 minutes of MT followed by 30 minutes of TOT per session.
The intervention will take place in the participant's home environment.
During the mirror practices, the patient will seat close to a table which the mirror box will be placed at the mid-sagittal plane.
During MT, the participant will be encouraged to actively move their paretic arm and hand concurrently with the mirror reflection of the movement of the nonparetic arm and hand as possible as they can.
If necessary, the therapist will assist the participant in moving the paretic hand to synchronize the movement with the nonparetic hand.
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Comparador activo: hospital-based therapy
hospital-based individualized occupational therapy
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The control group will receive a dose-matched, individualized occupational therapy at a hospital.
The participants will receive customary rehabilitation programs as usual performed at hospitals for 1 hour per session.
The treatment protocol will include: (a) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques, (b) fine motor or dexterity training, (c) arm exercises or gross motor training, (d) muscle strengthening of the affected upper limb, and (e) activities of daily living training or functional task practice.
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Experimental: hospital-based MTOT
hospital-based mirror therapy combined with task-oriented training (MTOT)
|
The hospital-based MTOT group will also receive 30 minutes of MT followed by 30 minutes of TOT per session at a hospital.
The intervention will take place in the occupational therapy clinic.
The treatment modalities in the hospital will be selected and provided for this group.
Most of the treatment principles and components are the same as aforementioned in the home-based MTOT.
However, the major differences between home-based and hospital-based MTOT are the treatment contexts, environments and functional modalities used.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change scores of Fugl-Meyer Assessment (FMA)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Modified Rankin Scale (mRS)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Change scores of Box and Block Test (BBT)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of grip and pinch power
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Revised Nottingham Sensory Assessment (RNSA)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Barthel Index (BI)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Activity monitors (ActiGraph)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Stroke Impact Scale (SIS) Version 3.0
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Motor Activities Log (MAL)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
Periodo de tiempo: baseline, 4 weeks, 3 months
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baseline, 4 weeks, 3 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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World Health Organization Quality of Life (WHOQOL)-BREF
Periodo de tiempo: baseline, 4 weeks
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for caregiver evaluation
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baseline, 4 weeks
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satisfaction questionnaire
Periodo de tiempo: baseline, 4 weeks
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baseline, 4 weeks
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patient-reported fatigue and pain ratings
Periodo de tiempo: baseline, 4 weeks
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baseline, 4 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 marzo de 2016
Finalización primaria (Actual)
1 de noviembre de 2016
Finalización del estudio (Actual)
1 de noviembre de 2016
Fechas de registro del estudio
Enviado por primera vez
29 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2015
Publicado por primera vez (Estimar)
4 de mayo de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de febrero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
5 de febrero de 2017
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 103-7164A3
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