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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Toka Adel Mohammed Fahmy, physiotherapist
- 電話番号：+201064030561
- メール：pttokaadel@gmail.com
研究場所
-
-
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Zagazig、エジプト
- El-Qenayat Central Hospital
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コンタクト：
- Toka Adel Mohammed Fahmy, physiotherapist
- 電話番号：+201064030561
- メール：pttokaadel@gmail.com
-
-
参加基準
適格基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
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.
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
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
アクティブコンパレータ：Otago exercise group
Otago exercise plus conventional treatment for neuropathy.
for 3d/w for 8weeks.
|
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
|
|
アクティブコンパレータ：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.
|
|
アクティブコンパレータ：control group
Only 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
|
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
Balance: ( Time up & go test )dual task
時間枠：From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
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|
Balance: Berg Balance Scale
時間枠：From enrollment to the end of the treatment at 8 weeks
|
From enrollment to the end of the treatment at 8 weeks
|
|
Gait speed (10m walk test)
時間枠：From enrollment to the end of the treatment at 8 weeks
|
From enrollment to the end of the treatment at 8 weeks
|
二次結果の測定
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Functional reach test.
時間枠：From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
|
Modified fall efficacy scale
時間枠：From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
|
Toronto clinical neuropathy score
時間枠：From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
協力者と研究者
捜査官
捜査官
- 主任研究者：Gehad Ali Abd-Elhasseb, Assistant Professor、Cairo University
- 主任研究者：Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy、Cairo University
- 主任研究者：Eman Mohamed El-Sayed Deif, consultant internal medicine
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- balance exercise for elderly
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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