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The Middle East "Stepping Forward" Project (MESF) (MESF)

3 de noviembre de 2011 actualizado por: Fany Tusia, Assaf-Harofeh Medical Center

Improving Treatment of People With Movement Disorders in the Middle East

The overall objective is to improve the functional status of Middle East adolescents with disabilities due to cerebral palsy (CP) and disabilities in adults due to cerebro-vascular stroke (Hemiplegia) by a collaborative Jordanian-Israeli-Palestinian-Moroccan applied research project.

Descripción general del estudio

Estado

Desconocido

Condiciones

Intervención / Tratamiento

Descripción detallada

Specific objectives are:

To compare the efficacy of two rehabilitation technologies to facilitate neural reorganization, transfer and retention of treatments results to improve walking in real life situations The investigators suggest a new approach of treatment intervention that will induce unexpected changes of underfoot slopes during walking and will force the central nervous system (CNS) to react and solve problems.

The investigators also propose that the new approach will have a significantly superior motor function improvement that will be transferred to real environmental settings and be retained for long periods of time.

Research methods and materials

Subjects:

A total of 166 subjects will be studied in two groups of handicapped persons:

  1. 83 Teenagers with cerebral palsy: the CP group
  2. 83 Subjects with chronic hemiparesis: the HP group

Each group will be sub-divided into three secondary groups, having similar age distributions and level of motor function for the two different therapy approaches:

  • 21 Treadmill exercise training
  • 21 Training by randomized perturbations wearing the Random Shoe system
  • 21 Training with dummy shoes without perturbations

The time flow protocol:

Recruiting subjects according to inclusion/exclusion criteria

The subjects will be tested with the following measures (see arms)at

  • T0 before starting the interventions to form a base line
  • T1 after 12 weeks of intensive treatments 3 x week 45 min.
  • T2 6 months after T1, after the treatment was stopped, to check retainment of results of the treatments after a period of normal daily schedule of the subject

The treatments will start in a week from T0 The T1 will be performed in a week after the treatment was completed The T2 will be performed 6 months (take or leave 2 weeks) after T1, 6 months after treatment was stopped.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

120

Fase

  • Fase 2

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.

Estudio Contacto

  • Nombre: Simona Bar-Haim, PhD
  • Número de teléfono: +972 8 9778280
  • Correo electrónico: adi-star@013.net

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Israel
      • Zerifin, Israel, 70300
        • Reclutamiento
        • Assaf Harofeh Medical Center
        • Contacto:
          • Simona Bar-Haim, PhD
          • Número de teléfono: +972 8 9778280
          • Correo electrónico: adi-star@013.net
        • Contacto:
        • Sub-Investigador:
          • Mark Belokopytov, PhD

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

14 años a 69 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Inclusion criteria for CP group:

  1. Diagnosis of cerebral palsy
  2. Predominantly spastic type of CP with distribution of diplegia / tetraplegia
  3. Age: 14 - 20 yr
  4. GMFCS (gross motor function classification system) at levels II & III
  5. A cognitive level sufficient to comprehend and cooperate in treatment and testing
  6. No orthopedic surgery or other tone reduction intervention in last 6 months
  7. Not a candidate for orthopedic surgical or other tone reduction intervention.

Exclusion criteria for CP group:

  1. Candidates for orthopedic surgical or any other tone reduction procedures, e.g., botulin injections, baclofen pump interventions
  2. Cannot cooperate in treatment or understand instructions
  3. Uncontrolled convulsions if epileptic
  4. Adolescents with progressive degenerative conditions of CNS or/and muscle-skeletal system.

Inclusion Criteria:

Inclusion criteria for HP group:

  1. Stroke survivors in chronic stage (1 year or more following stroke
  2. Age: 40 - 65 yr
  3. Mild to moderate gait with ability to ambulate > 10m with or without assistive device
  4. Cognitive level sufficient to comprehend and cooperate in tests and training
  5. Mini-mental state examination (MMSE) score > 24 6: Receive medical clearance from their family physician.

Exclusion Criteria:

Exclusion criteria for HP group:

  1. Dementia (Mini-Mental Score < 24)
  2. Severe aphasia
  3. Heart failure
  4. Other medical conditions that preclude participation in low-intensity treadmill walking

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: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Re-Step

Mechatronic shoe with a sole made to change slopes in the swing phase of walking.

This unpredictable change will introduce a situation of necessary adaptation to keep balance
Dispositivo: Chaotic Perturbation
Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the random shoes and perform a set of exercises following specific verbal tasks, e.g., "Walk 5 strides forward," or, "Walk to the right side until I ask you to stop." During this stage of walking the device will impose perturbations in the range tolerated by the subject. The therapist will make a written report of each session.
Otros nombres:
  • Re-Step shoes
Experimental: Dummy shoes
The shoes are in the same shape and weight of the Re-Step without the perturbations.
Dispositivo: Dummy not active shoes
Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the dummy shoes and perform a set of exercises following specific verbal tasks, e.g., "Walk 5 strides forward," or, "Walk to the right side until I ask you to stop." During this stage of walking the device will not impose perturbations. The therapist will make a written report of each session.
Otros nombres:
  • Dummy Shoes
Comparador activo: treadmill
A treadmill with safety adaptation and all the usual characteristics of speed and slopes of fitness treadmills.
Dispositivo: Treadmill training
Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will exercise basic stretching and muscle strengthening, then walk on the treadmill. A physiotherapist according the subject's rate of improvement will determine the increase in treadmill velocity and slope. The therapist will make a written report after each session.
Otros nombres:
  • Rueda de andar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
10 meter walk test (10MWT)
10-meter walk test (Rossier & Wade, 2001) will assess normal walking speed. The participant walks a straight path distance of 10 meters at normal walking speed with time recorded. The test will be performed twice with the number of steps counted. The tester or an assistant remains near the participant to prevent a fall or injury if they appear unsteady.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
6 Minuets Walk Test (6MinWT)
The 6-minute walk test (Enright, 2003) will be used to assess walking endurance. Subjects are instructed to cover as much distance as possible while walking around a marked course for 6 minutes. A member of the research staff will closely monitor the subjects.
Mechanical Efficiency
Mechanical efficiency will be measured by the stair-climbing test (SCT) (Bar-Haim, et al. 2004; 2008). Metabolic cost is predicted from heart rate during the external work while stair-climbing and mechanical efficiency is calculated.
WHOQOL-BREF
The WHO's Quality of Life (WHOQoL-BREF) is an international cross-culturally comparable quality of life assessment instrument. It assesses the individual's perceptions in the context of their culture and value systems, and their personal goals, standards and concerns.
Berg Balance Scale (BBS)
The BBS is a 14-item scale that quantitatively assesses balance and risk for falls in older community-dwelling adults through direct observation of their performance.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Assaf-Harofeh Medical Center

Investigadores

  • Investigador principal: Eli Lahat, MD Proffesor, Assaf-Harofeh Medical Center

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

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 2010

Finalización primaria (Actual)

1 de abril de 2011

Finalización del estudio (Anticipado)

1 de abril de 2012

Fechas de registro del estudio

Enviado por primera vez

5 de septiembre de 2011

Primero enviado que cumplió con los criterios de control de calidad

3 de noviembre de 2011

Publicado por primera vez (Estimar)

6 de noviembre de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de noviembre de 2011

Última actualización enviada que cumplió con los criterios de control de calidad

3 de noviembre de 2011

Última verificación

1 de noviembre de 2011

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HT 5283 152/09
  • Yad Hanadiv 5106 (Otro número de subvención/financiamiento: Yad Hanadiv Foundation; CPIRF)

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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