- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07773922
Otago Exercise Program in Chemotherapy Induced Peripheral Neuropathy
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
Statut
Intervention / Traitement
Description détaillée
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.
- 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.
- (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.
- 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
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Egypt
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Giza, Egypt, Egypte, 12613
- 1 Gamma street ,Giza, Egypt -postal code:12613
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
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
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.
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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.
|
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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.
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resistance exercises with elastic bands, strengthening exercises, and lower limb exercises, three sessions per week for 8 weeks.
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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
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Muscle strength of the lower limb muscles will be assessed using a Hand-Held Dynamometer (HHD).
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Baseline and after 8 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Modified Total Neuropathy Score (mTNS)
Délai: Baseline and after 8 weeks
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Chemotherapy-induced peripheral neuropathy severity will be assessed using the Modified Total Neuropathy Score (mTNS).
|
Baseline and after 8 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Cairo University, Faculty of Physical Therapy
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies du système nerveux
- Maladies musculaires
- Manifestations neuromusculaires
- Processus pathologiques
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Faiblesse musculaire
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Thérapeutique
- Modalités de physiothérapie
- Soins aux patients
- Thérapie d'exercice
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Conditionnement physique, humain
- Exercice
- Formation en résistance
Autres numéros d'identification d'étude
- OTAGO-CIPN-P.T.REC/012/006339
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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