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Otago Exercise Program in Chemotherapy Induced Peripheral Neuropathy

15 de agosto de 2026 actualizado por: Merna Fawzy Fouad Reyad, Cairo University

Impact of Otago Exercise Program on Muscle Weakness in Patients With Chemotherapy Induced Peripheral Neuropathy

Forty-eight participants between the age of 35 to 55years patient treated with Taxane chemotherapy, will be randomly divided into two equal groups, each comprising 24 patients.

  • Group (A): Consists of twenty- four patients have chemo therapy Induced peripheral Neuropathy and will receive Otago exercise plus resistance exercise 3times per week for 8weeks
  • Group (B): Consists of twenty- four patients with Chemotherapy induced peripheral Neuropathy who will receive conventional physical therapy program including: resistance exercise for 8weeks , 3 times per week.

Descripción general del estudio

Descripción detallada

  1. Subject:

    Forty-eight participants between the age of 35 to 55years patient treated with Taxane chemotherapy, will be randomly divided into two equal groups, each comprising 24 patients.

    • forty-eight patient, will be assigned to two equal matched groups randomly:(twenty-four patient for each group)
    • Group (A): Consists of twenty- four patients have chemo therapy Induced peripheral Neuropathy and will receive Otago exercise plus resistance exercise 3times per week for 8weeks
    • Group (B): Consists of twenty- four patients with Chemotherapy induced peripheral Neuropathy who will receive conventional physical therapy program including: resistance exercise for 8weeks, 3 times per week.
  2. Equipments

(1)Therapeutic equipment and tools:

(1)(a)Otago Exercise Program: The session started with a moderate warm-up for joint mobility and flexibility, followed by strengthening exercises for the hips, knees and ankles. Balance activities, including walking and stance challenges, came next, and the session ended with a normal-paced walk and cool-down. All exercises were adapted to participants' ability levels.

  1. (b)- Therabands for resistance Elastic bands provide a safe and effective method for improving physical function and muscle strength. The findings highlight the importance of power-resistance training and improving quality of life. Elastic bands are emphasized as a low-cost, practical option for seniors to perform resistance training.
  2. Measurement procedure:

2-(a) Hand Held Dynamometer(HHD):

A Hand-Held Dynamometer (HHD) is a portable device used to measure muscle strength objectively. It measures the maximum force a muscle or muscle group can generate during an isometric contraction.It is commonly used in:

Physical therapy, Rehabilitation, Sports medicine and Clinical research.The examiner places the device against the patient's limb while the patient pushes as hard as possible against it. The device records the peak force produced by the muscle.Depending on the device, results may be displayed in:Newtons (N), Kilograms-force (kgf or kg) or Pounds-force (lbf or lb).

(2)(b)Modified Total Neuropathy Score (mTNS) is a clinical assessment tool used to evaluate the severity of peripheral neuropathy, particularly in patients with Chemotherapy-Induced Peripheral Neuropathy (CIPN). It is a modified version of the Total Neuropathy Score (TNS) that is simpler and more practical for clinical and research use because it does not require nerve conduction studies.The mTNS typically assesses: Sensory symptoms (e.g., numbness, tingling, pain),Motor symptoms (e.g., muscle weakness),Pin sensibility,Vibration sensibility,Muscle strength and deep tendon reflexes.Each item is scored from 0 (normal) to 4 (severe impairment).

Individual scores are added to obtain the total mTNS score.Higher scores indicate more severe peripheral neuropathy.

Tipo de estudio

Intervencionista

Inscripción (Actual)

48

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.

Ubicaciones de estudio

    • Egypt
      • Giza, Egypt, Egipto, 12613
        • 1 Gamma street ,Giza, Egypt -postal code:12613

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:

  • Adults aged 35-55 years. Patients undergoing taxane chemotherapy. Diagnosed with chemotherapy-induced peripheral neuropathy (CIPN). Able to understand and follow assessment and treatment instructions. Willing to provide written informed consent.

Exclusion Criteria:

  • Pre-existing neurological disorders (e.g., multiple sclerosis, stroke, or Parkinson's disease).

Symptomatic heart disease, including congestive heart failure, arrhythmia, or myocardial infarction within the previous 3 months.

Severe orthopedic conditions, fractures, or chronic debilitating diseases limiting participation in the exercise program.

Psychological, cognitive, or emotional disorders affecting participation. Uncooperative patients or those unable to follow the exercise protocol. Refusal or inability to provide informed consent

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Otago Exercise Plus Resistance Exercise
Participants will receive the Otago Exercise Program in addition to resistance exercises using elastic bands, three sessions per week for 8 weeks.
An individualized Otago Exercise Program including warm-up, lower limb strengthening, balance, walking, and flexibility exercises. The program is delivered three times per week for 8 weeks under the supervision of a physical therapist.
Comparador activo: Resistance exercises
Participants will receive a conventional physical therapy program including resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.
resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
Periodo de tiempo: Baseline and after 8 weeks
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
Baseline and after 8 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Modified Total Neuropathy Score (mTNS)
Periodo de tiempo: Baseline and after 8 weeks
Chemotherapy-induced peripheral neuropathy severity will be assessed using the Modified Total Neuropathy Score (mTNS).
Baseline and after 8 weeks

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Cairo University, Faculty of Physical Therapy

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 (Actual)

1 de enero de 2026

Finalización primaria (Actual)

1 de marzo de 2026

Finalización del estudio (Actual)

1 de abril de 2026

Fechas de registro del estudio

Enviado por primera vez

15 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

15 de agosto de 2026

Publicado por primera vez (Actual)

19 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

19 de agosto de 2026

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

15 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

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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