Enhancing Participation of Chronic Stroke Patients by Constraint Induced Movement Therapy (HOMECIMT) (HOMECIMT)
14 de diciembre de 2014 actualizado por: Universitätsklinikum Hamburg-Eppendorf
Enhancing Participation of Chronic Stroke Patients in Primary Care by Modified Constraint Induced Movement Therapy (HOMECIMT)
The aim of this study is to evaluate the efficacy of a modified approach of constraint induced movement therapy ("CIMT at home") for chronic stroke patients, compared to conventional physiotherapy and occupational therapy ("therapy as usual) with regard to the ability to participate in everyday activities.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The study is a parallel cluster randomized controlled trial with therapy practices as clusters.
After written consent from the patients, the therapists are randomly assigned to treat either the intervention or the control group.
Blinded external assessors evaluate the patients using standardized outcome measures before and after the intervention, and six months later.
The two coprimary endpoint assessments of arm and hand function as prerequisites for participation (defined as equal involvement in activities of daily living) are quality of arm and hand use and arm and hand function.
Assessments are made four weeks post-treatment and relativized to baseline performance.
Changes in primary outcomes are analyzed with mixed models, which consider the hierarchical structure of the data, adjusted to the baseline measurements and sex.
The primary analysis compares the two randomized groups, with respect to the adjusted averages for each of the two coprimary endpoints.
To keep an overall significance level of 5%, the two endpoints are tested at the significance level of 5% each in hierarchical order.
Tipo de estudio
Intervencionista
Inscripción (Actual)
156
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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Hamburg, Alemania, 20246
- Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
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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:
- age ≥ 18 years
- Stroke onset > 6 months prior to study enrollment
- upper extremity hemiparesis with impairment of hand and/or arm
- minimal function of the hand (at least 10º active wrist extension, at least 10º active of thumb abduction/extension, and at least 10º of extension two additional fingers)
- non-professional coach (e.g. family member)
- prescription of physical or occupational therapy
Exclusion Criteria:
- lack of knowledge of German
- serious impairment of verbal communication ability (e.g. severe aphasia)
- inability to consent (e.g. dementia)
- severe neuro-cognitive deficits (MMSE <23)
- terminal illness, life-threatening co-morbidity
- simultaneous participation in another treatment study targeting stroke recovery
- subjects may not have already received constraint induced movement therapy
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: mod. Constraint-Induced Movement Therapy
CIMT at home is applied in the patients' home over the course of four weeks including (i.e.
20 consecutive days) 2 hours of daily training together with an instructed non-professional coach (e.g.
family member) applying shaping techniques.
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Therapists of the intervention group are trained in "CIMT at home".
During an initial home visit the therapist determines together with the patient an individually tailored home training program focussing on everyday practice and instructs the non-professional coach.
For four weeks the patients will perform 2 hours of daily training at home together with an instructed non-professional coach (e.g.
family member) applying shaping techniques (i.e.
20 consecutive days).
Patients are supposed to wear a resting hand splint for the entire treatment period for 4 to 6 hours daily.
During the four weeks the therapist will provide 5 weekly visits at the patients' home to instruct and supervise the training.
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Otro: Therapy as usual
Patients in this arm will receive usual care dose-matched to the intervention group (250-300 minutes).
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Therapy as usual consists of the therapy, which is usually provided by the occupational or physical therapist.
Therapy will be applied at the patients home or at the therapists' practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Motor Activity Log - Quality Of Movement (MAL-QOM) and Wolf Motor Function Test - Performance Time (WMFT-PT)
Periodo de tiempo: 4 weeks (post-treatment) relative to baseline performance
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"Participation" defined as equal involvement in all aspects of society and daily living for people with disabilities is a composite outcome of the following two measures: The MAL-QOM is a self-administered measure of how well 30 daily activities are performed to assess the change in the quality of arm and hand use and the WMFT-PT, measured as the average time (in seconds) to complete 15 tasks, to evaluate the change in arm and hand function.
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4 weeks (post-treatment) relative to baseline performance
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Motor Activity Log - Quality Of Movement (MAL-QOM) and MAL- Amount Of Use (MAL-AOU)
Periodo de tiempo: 3 and 6 months relative to baseline performance
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to assess the change in the quality and amount of arm and hand use
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3 and 6 months relative to baseline performance
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Wolf Motor Function Test - Performance Time (WMFT-PT) and WMFT Functional Ability (WMFT-FA)
Periodo de tiempo: 6 months relative to baseline performance
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to assess the change in time and quality of movement
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6 months relative to baseline performance
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Nine-Hole Peg-Test
Periodo de tiempo: 4 weeks (post-treatment) and 6 months relative to baseline performance
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to assess finger dexterity
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4 weeks (post-treatment) and 6 months relative to baseline performance
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Stroke-Impact-Scale (SIS)
Periodo de tiempo: 4 weeks (post-treatment) and 6 months relative to baseline performance
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to assess the impact on health and quality of life.
A self-administered 59-item questionnaire, which assesses 8 domains of stroke (Strength, Hand Function, Activities of Daily Living / Instrumental Activities of Daily Living, Mobility, Communication, Emotion, Memory and Thinking, and Participation)
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4 weeks (post-treatment) and 6 months relative to baseline performance
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Barthel Index(BI)
Periodo de tiempo: 4 weeks (post-treatment) and 6 months relative to baseline performance
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to assess functional disability i.e. to which somebody can function independently and has mobility in their activities of daily living (ADL)
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4 weeks (post-treatment) and 6 months relative to baseline performance
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Instrumental Activities of Daily Living Scale (IADL)
Periodo de tiempo: 4 weeks (post-treatment) and 6 months relative to baseline performance
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to asses self-maintaining and instrumental activities of daily living
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4 weeks (post-treatment) and 6 months relative to baseline performance
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anne Barzel, MD, Department of Primary Medical Care, University Medical Center Hamburg-Eppendorf
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
- Barzel A, Ketels G, Stark A, Tetzlaff B, Daubmann A, Wegscheider K, van den Bussche H, Scherer M. Home-based constraint-induced movement therapy for patients with upper limb dysfunction after stroke (HOMECIMT): a cluster-randomised, controlled trial. Lancet Neurol. 2015 Sep;14(9):893-902. doi: 10.1016/S1474-4422(15)00147-7. Epub 2015 Jul 28.
- Barzel A, Ketels G, Tetzlaff B, Kruger H, Haevernick K, Daubmann A, Wegscheider K, Scherer M. Enhancing activities of daily living of chronic stroke patients in primary health care by modified constraint-induced movement therapy (HOMECIMT): study protocol for a cluster randomized controlled trial. Trials. 2013 Oct 14;14:334. doi: 10.1186/1745-6215-14-334.
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 octubre de 2011
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
26 de abril de 2011
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2011
Publicado por primera vez (Estimar)
28 de abril de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
16 de diciembre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
14 de diciembre de 2014
Última verificación
1 de diciembre de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- BMBF-01-GX-1003
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. .