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Effect of Adding Augmented Cues /Hand Stroke Patient (AUGMENTED CUES)

13 de junio de 2026 actualizado por: Mostafa Abdullah Abdelazim Ahmed, Cairo University

Effect of Adding Augmented Cues to Physical Therapy Intervention on Hand Function Post Stroke Patients

This study aims to investigate the effect of adding augmented cues to conventional physical therapy intervention on hand function in patients with post-stroke hemiparesis. Fifty patients with subacute ischemic stroke will be randomly assigned to either a study group receiving augmented cue-based training in addition to conventional physical therapy or a control group receiving conventional physical therapy alone. Hand function will be assessed before and after the intervention period using the Nine-Hole Peg Test (NHPT), hand grip strength measured by a dynamometer, and pressure pain threshold measured by a pressure algometer. The findings of this study may provide evidence regarding the effectiveness of augmented cue-based rehabilitation strategies in improving hand function after stroke.

Descripción general del estudio

Descripción detallada

Stroke is one of the leading causes of long-term disability worldwide and frequently results in impaired hand function, reduced dexterity, decreased grip strength, and limitations in activities of daily living. Conventional physical therapy is commonly used to improve upper extremity function; however, recovery of hand performance remains challenging for many stroke survivors.

Augmented cues provide additional sensory information through visual, auditory, or sensorimotor feedback that may enhance motor learning and neuroplasticity. Incorporating augmented cues into rehabilitation programs may improve patient engagement, increase repetition of task-specific movements, and facilitate functional recovery.

The purpose of this randomized controlled trial is to examine the effectiveness of adding augmented cue-based training to conventional physical therapy intervention in improving hand function among patients with subacute ischemic stroke.

A total of 50 participants meeting the eligibility criteria will be recruited and randomly assigned into two equal groups:

Study Group: Participants will receive augmented cue-based training combined with conventional physical therapy.

Control Group: Participants will receive conventional physical therapy only.

The intervention will be conducted over an eight-week treatment period. Outcome measures will be collected before and after treatment and will include:

  1. Nine-Hole Peg Test (NHPT) to assess manual dexterity.
  2. Hand grip strength measured using a hand dynamometer.
  3. Pressure pain threshold measured using a pressure algometer.

The primary objective is to determine whether the addition of augmented cues results in greater improvement in hand function compared with conventional physical therapy alone. The results may contribute to the development of more effective rehabilitation strategies for individuals recovering from stroke.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

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.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: mariam mohamed elsayed, phd
  • Número de teléfono: 002010950505529
  • Correo electrónico: mariamelanany5@gmail.com

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

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • - Male and female patients.
  • Age between 40 and 60 years.
  • First-ever subacute ischemic stroke.
  • Time since stroke between 6 weeks and 6 months.
  • Unilateral upper limb involvement.
  • Able to understand and follow verbal instructions.
  • Medically stable and able to participate in the rehabilitation program.
  • Willing to provide informed consent.

Exclusion Criteria:

  • - Hemorrhagic stroke.
  • Bilateral stroke involvement.
  • Severe cognitive impairment or severe aphasia interfering with participation.
  • Severe visual or auditory deficits affecting training.
  • Severe upper limb spasticity that prevents hand training.
  • Other neurological disorders affecting upper limb function.
  • Severe musculoskeletal disorders of the upper limb.
  • Participation in another rehabilitation trial during the study period.
  • Unstable cardiovascular or medical conditions.

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: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: control group
Participants will receive a conventional physical therapy program for hand rehabilitation after stroke. Treatment will be administered three times per week for eight weeks (24 sessions), with each session lasting 60 minutes and including range of motion exercises, strengthening exercises, stretching, and task-oriented hand training.
Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke. The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training. Treatment will be provided three times per week for eight weeks (24 sessions).
Experimental: musical gloves
articipants will receive the same conventional physical therapy program provided to the control group in addition to MusicGlove training. Treatment will be administered three times per week for eight weeks (24 sessions). MusicGlove will provide augmented visual, auditory, and performance feedback during task-specific hand training.
Participants will receive a conventional physical therapy program for upper limb and hand rehabilitation after stroke. The program includes stretching exercises, range of motion exercises, strengthening exercises, and task-oriented hand training. Treatment will be provided three times per week for eight weeks (24 sessions).
MusicGlove is a sensor-based rehabilitation device that provides augmented visual, auditory, and performance feedback during task-specific hand exercises. Participants perform repetitive thumb-to-finger opposition and grasping movements synchronized with computer-based musical activities. Training will be provided in addition to conventional physical therapy three times per week for eight weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Nine-Hole peg Test (NHPT)
Periodo de tiempo: Baseline and after 8 weeks of treatment
Manual dexterity assessed using the Nine-Hole Peg Test. The time required to place and remove nine pegs will be recorded in seconds. Lower scores indicate better hand dexterity.
Baseline and after 8 weeks of treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
hand grip strength
Periodo de tiempo: Baseline and after 8 weeks of treatment
Hand grip strength will be assessed using a calibrated hand dynamometer. Participants will perform maximal voluntary grip contractions, and the average value of three trials will be recorded in kilograms. Higher values indicate greater hand strength.
Baseline and after 8 weeks of treatment
pressure pain threshold
Periodo de tiempo: Baseline and after 8 weeks of treatment
Pressure pain threshold of the Extensor Carpi Radialis Brevis muscle will be measured using a digital pressure algometer. Pressure will be applied at a standardized rate until the participant first perceives pain. Higher values indicate lower pain sensitivity.
Baseline and after 8 weeks of treatment

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Silla de estudio: Moshera H Darwish, PHD, Professor of Physical Therapy for Neurology and Neurosurgery Faculty of Physical Therapy Cairo University
  • Director de estudio: mariam m elsayed, phd, Lecturer in department of physical Therapy for Neurology and Neurosurgery Faculty of physical therapy Cairo University
  • Director de estudio: Essam M Abdulwahab, PHD, Professor of Neurology Faculty of Medicine Al-Azhar university

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 (Estimado)

1 de agosto de 2026

Finalización primaria (Estimado)

1 de agosto de 2027

Finalización del estudio (Estimado)

1 de agosto de 2027

Fechas de registro del estudio

Enviado por primera vez

13 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de junio de 2026

Publicado por primera vez (Actual)

17 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

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

13 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will be available from the corresponding author upon reasonable request.

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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