Effect of Otago vs. Sensorimotor Training on Balance and Fall Risk in People With Diabetes
OTAGO VERSUS SENSORIMOTOR TRAINING ON DYNAMIC POSTURAL STABILITY AND RISK OF FALL IN DIABETIC PATIENTS.
The purpose of this study is to compare the effects of the Otago Exercise Program versus Sensorimotor Training on dynamic postural stability and risk of fall in patients with type 2 diabetes mellitus.
Participants will be randomly assigned into two equal intervention groups. One group will receive the Otago Exercise Program, while the other group will receive Sensorimotor Training. Both groups will participate in their respective exercise protocols for 8 weeks. Dynamic postural stability and the risk of falling will be assessed before and after the intervention period using standardized physical therapy evaluation tools.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Diagnosed with type 2 diabetes mellitus for at least 5 years.
- Body Mass Index (BMI) ranging from 18.0 to 27.4 kg/m2.
- Age between 45 and 55 years.
- Clinically and medically stable.
- Able to ambulate independently without assistive devices.
- Mild to moderate balance impairment based on the Mini-BESTest score.
- Glycated Hemoglobin (HbA1c) level of 6.5% or higher.
Exclusion Criteria:
- Severe diabetic complications (e.g., advanced neuropathy with complete loss of protective sensation, active foot ulcers, or lower limb amputations).
- Neurological disorders affecting balance other than diabetic neuropathy (e.g., stroke, Parkinson's disease, or multiple sclerosis).
- Musculoskeletal conditions severely affecting lower limb function (e.g., severe osteoarthritis, recent lower limb fractures, or major orthopedic surgery).
- Severe visual impairment not corrected by glasses or corrective lenses.
- Vestibular disorders causing balance impairment or acute dizziness.
- Significant liver or renal impairment.
- Uncontrolled cardiovascular conditions that limit exercise participation or present safety risks during physical activity.
- Cognitive impairment preventing the ability to understand or follow exercise instructions.
- Non-compliance or intervention dropouts (e.g., patients missing more than two weeks of sessions or voluntarily withdrawing from the study).
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Otago Exercise Group
Patients in this group will undergo the Otago Exercise Program, including balance and strength training exercises, 3 times per week for 8 weeks. |
The Otago Exercise Program consists of individually tailored progressive muscle-strengthening exercises (targeting lower limbs) and balance retraining exercises. Participants will perform the exercises 3 times per week for a total duration of 8 weeks. Each session lasts approximately 30 to 45 minutes under the direct supervision of a physical therapist. |
|
Экспериментальный: Sensorimotor Training Group
Patients in this group will undergo Sensorimotor Training focusing on progressive proprioceptive and dynamic balance exercises, 3 times per week for 8 weeks. |
Sensorimotor Training involves progressive dynamic balance and proprioceptive exercises performed on various surfaces (such as stable floor, foam pads, and balance boards) with sensory progression (eyes open/closed). Participants will perform the exercises 3 times per week for a total duration of 8 weeks. Each session lasts approximately 30 to 45 minutes under the direct supervision of a physical therapist. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
Временное ограничение: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
|
A 14-item clinical scale used to assess dynamic postural balance, functional mobility, and balance control across four domains (anticipatory, reactive postural control, sensory orientation, and dynamic gait). Total scores range from 0 to 28, where higher scores indicate better balance and lower fall risk. |
Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
|
|
Falls Efficacy Scale-International (FES-I)
Временное ограничение: Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
|
A 16-item questionnaire used to assess concern about falling during basic and complex daily activities. Scores range from 16 to 64, where higher scores reflect higher concern/fear of falling. |
Baseline (Pre-intervention) and after 8 weeks of intervention (Post-intervention).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Fasting Blood Glucose (FBG)
Временное ограничение: Baseline and after 8 weeks of intervention.
|
Assessed via lab blood sample to monitor glycemic control. |
Baseline and after 8 weeks of intervention.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Body Mass Index (BMI)
Временное ограничение: Baseline (Pre-intervention)
|
Calculated as weight in kilograms divided by height in meters squared (kg/m^2) using a standardized weight and height scale, according to the World Health Organization (WHO) criteria. |
Baseline (Pre-intervention)
|
|
Glycated Hemoglobin (HbA1c)
Временное ограничение: Baseline (Pre-intervention)
|
Assessed via laboratory venous blood sample analysis to measure average glycemic control over the preceding 2 to 3 months and confirm type 2 diabetes baseline status. |
Baseline (Pre-intervention)
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- P.T.REC/012/006643
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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