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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
|
实验性的：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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
大体时间：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)
大体时间：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).
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Fasting Blood Glucose (FBG)
大体时间：Baseline and after 8 weeks of intervention.
|
Assessed via lab blood sample to monitor glycemic control. |
Baseline and after 8 weeks of intervention.
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Body Mass Index (BMI)
大体时间：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)
大体时间：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)
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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