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Otago Exercise Program in Chemotherapy Induced Peripheral Neuropathy

15 août 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

  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.

Type d'étude

Interventionnel

Inscription (Réel)

48

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Modified Total Neuropathy Score (mTNS)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Les enquêteurs

  • Chercheur principal: Cairo University, Faculty of Physical Therapy

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2026

Achèvement primaire (Réel)

1 mars 2026

Achèvement de l'étude (Réel)

1 avril 2026

Dates d'inscription aux études

Première soumission

15 août 2026

Première soumission répondant aux critères de contrôle qualité

15 août 2026

Première publication (Réel)

19 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

19 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 août 2026

Dernière vérification

1 août 2026

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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