- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07715578
Effect of Balance Exercises on Performance in Amputee Football Players (AF-BALANCE)
Evaluation of the Effect of Balance Exercises on the Performance of Amputee Football Players
This randomized controlled study evaluated the effects of an 8-week balance and trunk stabilization exercise program on balance and functional performance in male amputee football players. Twenty athletes aged 18 to 45 years were randomly assigned to an intervention group or a control group.
The intervention group completed trunk stabilization, proprioceptive balance, and sport-specific plyometric exercises twice weekly in addition to routine football training. The control group continued routine football training only. Balance and functional mobility were assessed before and after the 8-week period using the Berg Balance Scale, the L-Test of Functional Mobility, and the Figure-of-8 Walk Test.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Sakarya, Turquía (Türkiye)
- Amputee Football Training Facility
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Male amputee football players aged 18 to 45 years.
- Unilateral lower-limb amputation.
- Classification as A1 according to the amputee football classification system.
- Active participation in amputee football for at least 6 months.
- Ability and willingness to participate in the study.
- Provision of written informed consent.
Exclusion Criteria:
- Bilateral lower-limb amputation.
- Insufficient experience in using crutches or a prosthesis.
- Any acute injury or serious neurological, cardiovascular, or other medical condition that could prevent completion of the L-Test of Functional Mobility, Figure-of-8 Walk Test, or exercise program.
- An active injury or rehabilitation condition preventing participation in football training.
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 |
|---|---|
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Sin intervención: Grupo de control
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Experimental: Grupo de ejercicios de equilibrio
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An 8-week exercise program performed twice weekly in addition to routine football training.
The program included trunk stabilization, proprioceptive balance exercises, and sport-specific plyometric jumping and agility exercises.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in L-Test of Functional Mobility Completion Time
Periodo de tiempo: Baseline and 8 weeks
|
Functional mobility, speed, agility, and dynamic balance were assessed using the L-Test of Functional Mobility.
Participants completed three trials, and the mean completion time was recorded in seconds.
Lower completion times indicate better functional performance.
Change was calculated by comparing the assessment performed at baseline with the assessment performed after the 8-week intervention.
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Baseline and 8 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Figure-of-8 Walk Test Completion Time
Periodo de tiempo: Baseline and 8 weeks
|
Dynamic balance, agility, postural control, and directional change ability were assessed using the Figure-of-8 Walk Test.
Participants completed three trials, and the mean completion time was recorded in seconds.
Lower completion times indicate better performance.
Change was assessed from baseline to the end of the 8-week intervention.
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Baseline and 8 weeks
|
|
Change in Figure-of-8 Walk Test Step Count
Periodo de tiempo: Baseline and 8 weeks
|
Movement efficiency during the Figure-of-8 Walk Test was assessed by recording the number of steps required to complete the test.
Participants completed three trials, and the mean step count was calculated.
A lower number of steps indicates greater movement efficiency.
Change was assessed from baseline to the end of the 8-week intervention.
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Baseline and 8 weeks
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Change in Berg Balance Scale Total Score
Periodo de tiempo: Baseline and 8 weeks
|
Static and functional balance were assessed using the Berg Balance Scale.
The scale contains 14 items scored from 0 to 4, providing a total score ranging from 0 to 56.
Higher scores indicate better balance and lower fall risk.
Change was assessed from baseline to the end of the 8-week intervention.
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Baseline and 8 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- NISAMAKTAY
Plan de datos de participantes individuales (IPD)
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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.
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