- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07576153
Effects of Unilateral Versus Bilateral Task Specific Training With Visual Feedback in Post Stroke Patients
Effects of Unilateral Versus Bilateral Task Specific Training With Visual Feedback on Lower Limb on Balance, Gait and Sensation in Post Stroke Patients
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lahore, Pakistán, 54000
- Department of Physical Therapy, Sahet Medical complex Lahore
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age 40-65 years
- Both gender male and female
- Pre diagnose with the Stroke
- Patient with a subacute phase (>3months post stroke)
- Ability to understand and follow the instructions (8)
- Berg Balance Scale (BBS) score between 21-40
- 10 meter walk test (0.4-0.8m/s)
Exclusion Criteria:
- Severe cognitive Impairment
- Visual and vestibular Impairment
- Other orthopedic or neurological disorder
- unilateral neglect
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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Experimental: bilateral task specific training with visual feedback
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The group will received bilateral task specific training along with visual feedback on lower limb.
Bilateral training is used in rehabilitation to promote functional recovery of impaired limbs by engaging both affected and non-affected sides.
Task specific training include weight shifting, sit to stand, stepping forward / lateral and bilateral walking over uneven surfaces.
Visual feedback will be given by mirrors and visual targets place on the floor.
Visual feedback helping patients to improve balance and body awareness, particularly for individuals with sensory or motor impairments following a stroke.
Bilateral task specific training with visual feedback will perform for five days per week for six weeks.
The participants in this group underwent 40 minutes of bilateral lower limb training.
Pre and post intervention values will be recorded to assess the effectiveness
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Experimental: unilateral task specific training with visual feedback
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This group received unilateral task specific training with visual feedback on affected limb.
Task specific training include weight shifting, seated marching, stepping forward / lateral, and walk on uneven surface.
Unilateral task specific training with visual feedback will perform for five days per week for six weeks.
The participants in this group underwent 40 minutes of unilateral lower limb training.
Pre and post intervention values will be recorded to assess the effectiveness.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Berg Balance Scale
Periodo de tiempo: 6 weeks
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Berg balance (BBG) is a widely used clinical test to assess a person's static and dynamic balance abilities. It consist of 14 performance based tasks each scored on a 5 point scale from 0 to 4 for a maximum total score of 56. It used for individuals with balance impairments such as post stroke patients. In scoring criteria 4 score perform task independently and safely, 3 score perform with supervision or slight assistance, 2 score perform with moderate assistance or deviation, 1score perform with major assistance and 0 score unable to perform The scoring range 41-56 low risk balance impairment, 21-40 moderate risk balance impairment and 0-20 high risk balance impairment Test retest (ICC =0.96; 95% CI, 0.93-0.98) and inter-rater (ICC=0.93; 95% CI, 0.87=0.97) reliability was excellent |
6 weeks
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Meter Walk Test (TMWT)
Periodo de tiempo: 6 weeks
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10 meter walk test is use to assess the gait and gait speed over a short distance.
It is an important predictor of functional independence, fall risk and community mobility.
It is perform by the patient to walk a total 14 meter at a comfortable speed, only the middle 10 meter are timed to eliminate acceleration and deceleration bias.
First 2 meter acceleration, middle 10 meter time walking and last 2 meter deceleration.
Repeat the test twice.
The Scoring of 10 meter walk test have predicted values, gait speed < 0.4 m/ s functional status (household ambulation), 0.4 - 0.8 m/s limited community ambulation, > 0.8 m/s community ambulation and > 1.2 m/s safe for crossing the street
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6 weeks
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Fugl- Meyer Assessment - Lower Extremity
Periodo de tiempo: 06 weeks
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Fugl Meyer Assessment Lower Extremity is widely used outcome tool to measure in rehabilitation, particularly for stroke patients. To measure the sensation, it include light touch sensation and proprioception. The scoring criteria each item is on a 3 point scale; 0 unable to perform the task, 1 impaired and 2 normal. The total score ranges from 0 to 10. Light touch 2 sites and 2 points total score 4. Proprioception 3 joints 2 points total score 6 |
06 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Zain Ul Abbas, Ms, Riphah International University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC/RCR & AHS/25/0223
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.
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