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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
Ramy czasowe: 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)
Ramy czasowe: 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).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Fasting Blood Glucose (FBG)
Ramy czasowe: Baseline and after 8 weeks of intervention.
|
Assessed via lab blood sample to monitor glycemic control. |
Baseline and after 8 weeks of intervention.
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Body Mass Index (BMI)
Ramy czasowe: 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)
Ramy czasowe: 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)
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- P.T.REC/012/006643
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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