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- Ensayo clínico NCT02115971
Jumping Exercises Approach in Individuals With Chronic Ankle Instability
The Effect of a 12-week Training Jumping Exercises Program in Individuals With Chronic Ankle Instability: Randomized Controlled Trial Pilot Study
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
There is a need for;
- more homogeneous sub- groups with chronic functional instability of the ankle.
- Studies are needed that older patients (up to 50 years) and also take into account women.
- 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
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
ZH
-
Zurich, ZH, Suiza, 8008
- Balgrist Univeresty Hospital
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
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
¿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)
|
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
Patrocinador
Investigadores
- Investigador principal: Jaap Swanneburg, PhD, Balgrist Univeresty Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
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.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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