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Jumping Exercises Approach in Individuals With Chronic Ankle Instability

19 de julio de 2016 actualizado por: Swanenburg

The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study

The aim of this pilot study is to analyze the effect of a 12-week specific jump training compared with conventional therapy in patients with chronic functional instability of the ankle. It is to be evaluated to what extent the symptoms in of chronic functional instability of the ankle can be influenced in everyday life.

Descripción general del estudio

Descripción detallada

There is a need for;

  1. more homogeneous sub- groups with chronic functional instability of the ankle.
  2. Studies are needed that older patients (up to 50 years) and also take into account women.
  3. In addition, studies should be performed in a clinical environment and also at the same time clinically adapted test can be used as a form measurement.

( Hiller et al. , 2011).

Tipo de estudio

Intervencionista

Inscripción (Actual)

10

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

    • ZH
      • Zurich, ZH, Suiza, 8008
        • Balgrist Univeresty Hospital

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 a 50 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Ankle injury more than 6 months ago
  • Chronic instability
  • Functional instability of the ankle
  • Experience with proprioceptive exercises

Exclusion Criteria:

  • Foot surgery
  • Fresh ankle injury
  • Acute foot pain with signs of inflammation
  • Mechanical / anatomical ankle instability
  • Athletes with regularly jumping exercise (eg volleyball, basketball)
  • Taking medications which affect balance and coordination
  • Diseases that affect the balance
  • Serious diseases such as tumors, infections, neuropathies, severe articular degeneration
  • Non-German-speaking patients

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
Experimental: Jumping exercise

Physical therapy with a focus on specific jumping exercise. The jumping exercise will be performed for 12 weeks (3x/week), with a break of day between workouts. The 40-minute workout is completed 2 times under supervision in the clinic's internal training group for outpatients. 1 time they train on their own at home, based on a defined training program. The training process is documented by the training protocol.

The incipient exercise intensity is taking personal performance into account. The exercise intensity is increased by a progressive scheme.

Total 120min exercise
Comparador activo: Strength exercise

Physical Therapy with a focus on stability and strength exercise. Strength exercise arm has also same duration of 12 weeks with comparable intensity. The program is according to a predetermined program. The 60-minute training is completed twice under supervision in the clinic's internal training group for outpatients.There is no contact with participants of other group.

Between the two exercise sessions there is a training free day. The training process is documented by the training protocol. The incipient exercise intensity is considering personal performance. The intensity is increased after workout usual principles. The exercises are described with clear image and load parameters. The training exercises are regularly monitored.

Total 120 min exercise

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Gait variables
Periodo de tiempo: Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)

Gait variables will be assessed with the OptoGait system OptoGait system is a floor-based photocell system for measuring spatiotemporal gait parameters.

All measurements will be executed within 1hour

Change from Baseline in Gait variables at week 3, week 7, and at the end of therapy (week 12)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Balance
Periodo de tiempo: Baseline, week 3, week 7, and at the end of therapy (week 12)

Time to Stability (Forceplate Accusway AMTI)

  • 1 leg jump test
  • step down test
Baseline, week 3, week 7, and at the end of therapy (week 12)
Health questionnaire
Periodo de tiempo: Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
EQ-5D is a standardised instrument for use as a measure of health outcome.
Baseline, week 3, week 7, and at the end of therapy (week 12), followup 12 months
Foot function questionnaire
Periodo de tiempo: Baseline, week 3, week 7, and at the end of therapy (week 12)
The Foot and Ankle Ability Measure (FAAM) is a self-report outcome instrument developed to assess physical function for individuals with foot and ankle related impairments.
Baseline, week 3, week 7, and at the end of therapy (week 12)
Personal calendar
Periodo de tiempo: 12 months
Participant could enter any new ankle sprain into this calendar. As soon as possible after new ankle sprain the participant had to fill in the date, its cause, and sprain-related injuries. The calendar pages contained questions about the circumstances surrounding the new ankle sprain, including how and where it happened, activity performed, possible injury symptoms, time to recover and whether medical assistance or physical therapy was needed. Participants are also requested to record direct medical costs (e.g. physiotherapy, visits to general practitioners and medical specialists, nursing care, and medication) and indirect cost (e.g. disability related loss) using the "personal calendar". At the end of 2 month, a calendar page was sent by each patient to the investigators
12 months

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Jaap Swanneburg, PhD, Balgrist Univeresty Hospital

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 2013

Finalización primaria (Actual)

1 de agosto de 2015

Finalización del estudio (Actual)

1 de agosto de 2015

Fechas de registro del estudio

Enviado por primera vez

3 de abril de 2014

Primero enviado que cumplió con los criterios de control de calidad

15 de abril de 2014

Publicado por primera vez (Estimar)

16 de abril de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

20 de julio de 2016

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

19 de julio de 2016

Última verificación

1 de julio de 2016

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • Balgrist 2009-124
  • KEK-ZH-Nr. 2009-124 (Otro identificador: Ethics commission of the Canton Zurich, Switzerland)

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

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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