- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04637737
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke
Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.
40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Seoul, Corea, república de
- Reclutamiento
- Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine
-
Contacto:
- Deog Young Kim
- Número de teléfono: +82-2-2228-3714
- Correo electrónico: KIMDY@yuhs.ac
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- less than 6 months after onset of the stroke
- can stand and walk independently 10m
- K-MMSE score of at least 15
- have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
- over 20 years of age.
Exclusion Criteria:
- quadriplegia
- past history of stroke
- past history of Musculoskeletal disease or history of Neurological diseases
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: Grupo de control
|
The control group received the usual gait training.
|
|
Experimental: Grupo de entrenamiento
|
The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK). Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side. On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value. It is designed to induce the maximum weight shift through the archery game. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Step Length Asymmetric Ratio
Periodo de tiempo: before training(0week)
|
Step Length Asymmetric Ratio = paretic step length/non paretic step length
|
before training(0week)
|
|
Step Length Asymmetric Ratio
Periodo de tiempo: during training(2week)
|
Step Length Asymmetric Ratio = paretic step length/non paretic step length
|
during training(2week)
|
|
Step Length Asymmetric Ratio
Periodo de tiempo: after training(4week)
|
Step Length Asymmetric Ratio = paretic step length/non paretic step length
|
after training(4week)
|
|
Step Length Asymmetric Ratio
Periodo de tiempo: Follow up(8week)
|
Step Length Asymmetric Ratio = paretic step length/non paretic step length
|
Follow up(8week)
|
|
Step Length Asymmetric Index
Periodo de tiempo: before training(0week)
|
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
|
before training(0week)
|
|
Step Length Asymmetric Index
Periodo de tiempo: during training(2week)
|
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
|
during training(2week)
|
|
Step Length Asymmetric Index
Periodo de tiempo: after training(4week)
|
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
|
after training(4week)
|
|
Step Length Asymmetric Index
Periodo de tiempo: Follow up(8week)
|
Step Length Asymmetric Index = paretic step length-non paretic step length/0.5[paretic
step length +non paretic step length]
|
Follow up(8week)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 4-2014-0383
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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. .