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.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Toka Adel Mohammed Fahmy, physiotherapist
- Número de teléfono: +201064030561
- Correo electrónico: pttokaadel@gmail.com
Ubicaciones de estudio
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Zagazig, Egipto
- El-Qenayat Central Hospital
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Contacto:
- Toka Adel Mohammed Fahmy, physiotherapist
- Número de teléfono: +201064030561
- Correo electrónico: pttokaadel@gmail.com
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Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Comparador activo: 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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Comparador activo: 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.
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Comparador activo: 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
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¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Balance: ( Time up & go test )dual task
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Functional reach test.
Periodo de tiempo: 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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Modified fall efficacy scale
Periodo de tiempo: 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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Toronto clinical neuropathy score
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Gehad Ali Abd-Elhasseb, Assistant Professor, Cairo University
- Investigador principal: Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy, Cairo University
- Investigador principal: Eman Mohamed El-Sayed Deif, consultant internal medicine
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- balance exercise for elderly
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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