Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
3 de abril de 2016 actualizado por: Dr. Brenda Brouwer, Queen's University
Client Centred 'Tune-ups': do They Enhance Community Reintegration and Mobility in Stroke Survivors?
Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation.
There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function.
The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.
Descripción general del estudio
Descripción detallada
The extent to which impairment (physical capacity) and function influence community reintegration is unclear.
One of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level.
Interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months.
It has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration.
This study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration.
Stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals.
Assessors will be blind to whether the subject is receiving a tune up.
Evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.
Tipo de estudio
Intervencionista
Inscripción (Actual)
103
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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Ontario
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Kingston, Ontario, Canadá, K7L 3N6
- Queen's University School of Rehabilitation Therapy
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London, Ontario, Canadá, N6G 1H1
- School of Physical Therapy, University of Western Ontario
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- first major unilateral hemispheric stroke,
- english speaking,
- adequate verbal communication,
- discharged home or residential care
Exclusion Criteria:
- serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)
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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Sin intervención: Control
natural progression post-stroke
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Experimental: Intervention
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
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two weeks intensive physical rehabilitation
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subjective Index of Physical and Social Outcome (SIPSO)
Periodo de tiempo: baseline and 1 year
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The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation.
Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales).
The total score reflects reintegration.
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baseline and 1 year
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Subjective Index of Social Integration (Subscale of SIPSO)
Periodo de tiempo: baseline and one year
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see Subjective Index of Physical and Social Outcome (SIPSO) above
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baseline and one year
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Subjective Index of Physical Integration (Subscale of SIPSO)
Periodo de tiempo: baseline and one year
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see 'Subjective Index of Physical and Social Outcome (SIPSO) above
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baseline and one year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mobility Function
Periodo de tiempo: baseline and 1 year
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Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds)
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baseline and 1 year
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Physical Capacity
Periodo de tiempo: baseline and 12 months
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6 minute walk test (6MWT).
Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.
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baseline and 12 months
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Health-related Quality of Life - Physical
Periodo de tiempo: baseline and one year
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The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health).
The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best.
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baseline and one year
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Health-related Quality of Life - Mental
Periodo de tiempo: baseline and one year
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The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health).
The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest.
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baseline and one year
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brenda J Brouwer, PhD, Queen's University
- Investigador principal: Jayne Garland, Ph.D, Western University, Canada
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.
Publicaciones Generales
- Brouwer B, Bryant D, Garland SJ. Effectiveness of Client-Centered "Tune-Ups" on Community Reintegration, Mobility, and Quality of Life After Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1325-1332. doi: 10.1016/j.apmr.2017.12.034. Epub 2018 Apr 3.
- Cohen JW, Ivanova TD, Brouwer B, Miller KJ, Bryant D, Garland SJ. Do Performance Measures of Strength, Balance, and Mobility Predict Quality of Life and Community Reintegration After Stroke? Arch Phys Med Rehabil. 2018 Apr;99(4):713-719. doi: 10.1016/j.apmr.2017.12.007. Epub 2018 Jan 6.
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 diciembre de 2006
Finalización primaria (Actual)
1 de noviembre de 2011
Finalización del estudio (Actual)
1 de enero de 2012
Fechas de registro del estudio
Enviado por primera vez
16 de noviembre de 2006
Primero enviado que cumplió con los criterios de control de calidad
16 de noviembre de 2006
Publicado por primera vez (Estimar)
17 de noviembre de 2006
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
5 de mayo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
3 de abril de 2016
Última verificación
1 de abril de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HS SRA 5974
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. .