- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07776535
Effects Of Otago Exercise Versus Multisensory Integration Training On Balance And Gait In Elderly With Diabetes (Balance - DM)
The goal of this clinical trial is to compare the effect of the Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus.
The main question it aims to answer is:
• Is there a significant difference between the effect of Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus? Researchers will compare Otago exercise to Multisensory integration training to know which one has the greatest benefit on balance &gait in the elderly with type2 diabetes.
Participants will be divided into 3 groups; each group takes a certain training program for 8 weeks:
- First group: Otago exercise group plus conventional treatment for neuropathy.
- Second group: Multisensory integration training group plus conventional treatment for neuropathy.
- Third group: control group takes only conventional treatment for neuropathy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Diabetes one of the most prevalent chronic non-communicable diseases. Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, affecting about 50% of diabetic patients.
DPN characterized by peripheral nerve dysfunction. It initially presents sensory symptoms like numbness and tingling, which may evolve into pain and heightened sensitivity. Subsequently, motor symptoms such as muscle weakness and coordination difficulties appear, potentially leading to muscle atrophy.
Due to all these changes affecting peripheral nerve function, the functions of the lower extremities will be disturbed, which facilitate normal posture and walking, resulting in a loss of somatosensation and proprioception. This decreased sensitivity in the feet leads to balance defects, particularly in elderly and diabetic individuals.
The Otago exercise program is effective in preventing falls in older adults by improving cognitive function, balance, strength, functional fitness, and recovery, while reducing costs. Furthermore, multisensory exercises enhance balance and mobility by targeting sensory systems, thus lowering fall risk compared to traditional methods focused on physical strength or motor skills.
Both interventions positively affect balance and mobility in older adults with type 2 diabetes, but direct comparisons of their effectiveness are limited. This study aims to fill that gap by evaluating two rehabilitation interventions, potentially aiding clinical decision-making by identifying the more effective option for enhancing postural stability and mobility.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Toka Adel Mohammed Fahmy, physiotherapist
- Numéro de téléphone: +201064030561
- E-mail: pttokaadel@gmail.com
Lieux d'étude
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Zagazig, Egypte
- El-Qenayat Central Hospital
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Contact:
- Toka Adel Mohammed Fahmy, physiotherapist
- Numéro de téléphone: +201064030561
- E-mail: pttokaadel@gmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Ninety elderly Patients of both genders.
- Their age will range from 65 to 75th.
- They will be diagnosed with type 2 diabetes for 5 years or more.
- Patients with mild & moderate neuropathy will be included. (Based on the Toronto scale: -mild (6-8); moderate (9-11)
- Berg balance between (21 to <50) patients with mild &moderate risk of fall .
- Time up & go dual task: patient takes longer than 10 sec.
- HBA1C for these patients was ≥ 6.5% .
- BMI will range from (18: 29,9 kg/m2).
- Able to walk independently, with or without assistive devices.
Exclusion Criteria:
- Any musculoskeletal disorder affecting the lower limb (fracture of the lower limb, tumors, any infection, ligament injuries, foot injuries).
- Any other neurological disorder influences gait such as (stroke, Parkinson's disease, cerebellar dysfunction, ataxia, vestibular disorders)
- Any other cardiovascular disease (arrhythmia, cardiac pacemakers).
- Unstable proliferative retinopathy and visual impairments without correction.
- Non-diabetic neuropathy (inflammatory, autoimmune disease, infections, tumors, vitamin B12 deficiency, hypothyroidism, alcoholism, injury or pressure on the nerve).
- The use of medications significantly impacting postural control (e.g., sedatives).
- Vestibular system and Cognitive disorders.
- Uncontrolled hypertension.
- Common peroneal nerve injury.
- Orthostatic hypotension.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Otago exercise group
Otago exercise plus conventional treatment for neuropathy.
for 3d/w for 8weeks.
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Exercise program consisted of ( flexibilty - strengthening - balance ) exercise for elderly. Time of each session (50:60 min). For 3d/w for 8weeks.
conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
|
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Comparateur actif: Multisensory integration training group
Multisensory integration training group with conventional treatment for neuropathy. for 3d/w for 8 weeks. |
conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
Multisensory integration training is a group of balance exercise depend on facilitating different sensory systems (visual-vestibular-propioception) Time for each session (50 min).
For 3d/w for 8weeks.
|
|
Comparateur actif: control group
Only conventional treatment for neuropathy For 3d/w for 8 weeks.
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conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Balance: ( Time up & go test )dual task
Délai: From enrollment to the end of treatment at 8 weeks
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From enrollment to the end of treatment at 8 weeks
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Balance: Berg Balance Scale
Délai: From enrollment to the end of the treatment at 8 weeks
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From enrollment to the end of the treatment at 8 weeks
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Gait speed (10m walk test)
Délai: From enrollment to the end of the treatment at 8 weeks
|
From enrollment to the end of the treatment at 8 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Functional reach test.
Délai: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
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Modified fall efficacy scale
Délai: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
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Toronto clinical neuropathy score
Délai: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gehad Ali Abd-Elhasseb, Assistant Professor, Cairo University
- Chercheur principal: Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy, Cairo University
- Chercheur principal: Eman Mohamed El-Sayed Deif, consultant internal medicine
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
Autres numéros d'identification d'étude
- balance exercise for elderly
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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