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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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. |
|
実験的：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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Mini-Balance Evaluation Systems Test (Mini-BESTest)
時間枠：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)
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fasting Blood Glucose (FBG)
時間枠：Baseline and after 8 weeks of intervention.
|
Assessed via lab blood sample to monitor glycemic control. |
Baseline and after 8 weeks of intervention.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Body Mass Index (BMI)
時間枠：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)
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。