Gait and Balance of Diabetes Type 2 Patients
Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy
Type 2 diabetes is one of the fastest growing public health problems in both developed and developing countries. It is estimated that the number of people with diabetes in the world will double in coming years, from 171 million in 2000 to 366 million in 2030.The role of physiotherapy in diabetic care is to reduce immobilisation effects, to maintain functional capacity and to minimise diabetes-related complications. The physiotherapist also has a role in providing advice about exercise and daily living activities. The fundamental principle of rehabilitation is to improve quality of life while diminishing the health care burden. By reducing the heightened risk of falling, the fall related injuries and the fear of falling one could improve quality of life in diabetic patients and reduce health care costs.
The goal of this study is to investigate the effectiveness of gait and balance training in pre frail subgroup diabetes patients. Our program is based on recommendations of Robertson et al.(2002) and Page et al.(2002) The investigators randomly assign patients in a control group (no treatment) or in a treatment group. The treatment program consists of two group sessions per week over 12 weeks. Patients were encouraged to perform specific home exercises. After this 12-week program, patients were asked to continue their exercises. The effect of the treatment will be evaluated after the treatment program and after a 6-month follow up.
調査の概要
研究の種類
入学 (実際)
段階
- フェーズ2
- フェーズ 3
連絡先と場所
研究場所
-
-
-
Geneva、スイス、1205
- University Hospital of Geneva
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Past or present patient from the University Hospital in Geneva
- Diagnosed with diabetes by the medical doctor (glycaemia > 7 mmol on two different tests on an empty stomach)
- Presence of a peripheral neuropathy (vibration perception ≤ 4)
Exclusion Criteria:
- Patients with a foot ulcer at the moment of intake
- Patients with orthopaedic or chirurgical problems influencing gait parameters
- Patients with a non diabetic neuropathy (Charcot, alcohol, Thyroid dysfunction)
- Patients with neurological problems influencing gait parameters
- Patients with incapacity to walk without a walking aid
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：A,1
Physiotherapy
|
Gait and Balance training based on recommendations of Robertson et al. and Page et al. (different balance control exercises; progression in consecutive stages: Sensimotor training, a static phase, a dynamic phase combined with functional tasks.
The treatment takes place twice a week over 12 weeks.
Patients were encouraged to perform specific home exercises.
他の名前：
|
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 |
時間枠 |
|---|---|
|
Gait parameter: comfortable speed
時間枠：Before treatment / After treatment / 6 month follow up
|
Before treatment / After treatment / 6 month follow up
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Other spatio temporal gait parameters and sagittal movement of lower limb
時間枠：Before Treatment/ After Treatment/ 6 month follow up
|
Before Treatment/ After Treatment/ 6 month follow up
|
|
Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)
時間枠：Before Treatment / After Treatment / 6 month follow up
|
Before Treatment / After Treatment / 6 month follow up
|
|
Fear of falling (Falls efficacy scale)
時間枠：Before Treatment / After Treatment / 6 month follow up
|
Before Treatment / After Treatment / 6 month follow up
|
協力者と研究者
協力者
捜査官
- 主任研究者：Lara E Allet, MPtSc、University Hospital and University Geneva
出版物と役立つリンク
一般刊行物
- Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, Staal JB, de Bruin ED. The gait and balance of patients with diabetes can be improved: a randomised controlled trial. Diabetologia. 2010 Mar;53(3):458-66. doi: 10.1007/s00125-009-1592-4. Epub 2009 Nov 17.
- Allet L, Armand S, Golay A, Monnin D, de Bie RA, de Bruin ED. Gait characteristics of diabetic patients: a systematic review. Diabetes Metab Res Rev. 2008 Mar-Apr;24(3):173-91. doi: 10.1002/dmrr.809.
- Turcot K, Allet L, Golay A, Hoffmeyer P, Armand S. Investigation of standing balance in diabetic patients with and without peripheral neuropathy using accelerometers. Clin Biomech (Bristol, Avon). 2009 Nov;24(9):716-21. doi: 10.1016/j.clinbiomech.2009.07.003. Epub 2009 Aug 14.
- Allet L, Armand S, de Bie RA, Golay A, Pataky Z, Aminian K, de Bruin ED. Clinical factors associated with gait alterations in diabetic patients. Diabet Med. 2009 Oct;26(10):1003-9. doi: 10.1111/j.1464-5491.2009.02811.x.
- Allet L, Armand S, de Bie RA, Pataky Z, Aminian K, Herrmann FR, de Bruin ED. Gait alterations of diabetic patients while walking on different surfaces. Gait Posture. 2009 Apr;29(3):488-93. doi: 10.1016/j.gaitpost.2008.11.012. Epub 2009 Jan 9. Erratum In: Gait Posture. 2009 Oct;30(3):394.
- Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, de Bruin ED. Reliability of diabetic patients' gait parameters in a challenging environment. Gait Posture. 2008 Nov;28(4):680-6. doi: 10.1016/j.gaitpost.2008.05.006. Epub 2008 Jun 25.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。