Motor Learning in Gait in Subjects With Diabetic Peripheral Neuropathy
調査の概要
詳細な説明
This study suggests that teaching a new strategy is beneficial to decrease the forefoot peak plantar pressure in individuals who are susceptible to plantar ulcerations. It has not, however, been studied whether these changes would be maintained long-term or if they had any effect on the ulceration rate. Additionally, no analysis of the amount of visual feedback necessary to elicit the desired motor pattern was discussed. It has been suggested that proprioception plays an integral role in the use of feedback to develop error-detection mechanisms by integrating visual feedback and kinesthetic variables. In the diabetic peripheral neuropathy subject population, proprioception and kinesthesia may be compromised. This may have effects on the ability of this population to maintain changes in inappropriate movement patterns. A significant portion of patients continue to develop plantar ulcers even with prescriptive footwear compliance, so gait training to change inappropriate patterns which result in the high plantar pressures may be critical to prevent ulceration.
Comparisons: Two groups of subjects will receive gait training, one group will receive feedback of performance while the other will only receive training, and one control group. Comparisons will include whether plantar pressures are decreased in the training groups, and if those changes are maintained long-term.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
California
-
West Los Angeles、California、アメリカ、90073
- VA Greater Los Angeles Healthcare System, West LA
-
-
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:
- Diagnosis of diabetes for at least one year.
- Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested (31;32)
- Age 50-80 years old
- Able to ambulate independently without assistive devices (e.g. walker or crutches) (8) for 30 feet.
- No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions
Exclusion Criteria:
- Other non-diabetic causes of neuropathy by history
- Symptomatic peripheral vascular disease
- Joint pain, swelling and/or limited of range of motion in the lower extremities that interfere with walking or exercise
- Visual problems not correctable with glasses or contact lens
Passive range of motion limitations are described as:
- Hip flexion < 1000;
- Hip extension < 200;
- Knee flexion < 1250;
- Knee extension < 00 (unable to obtain full extension);
- Ankle plantar flexion < 250;
- Ankle dorsiflexion < 150
- Other systemic or local diseases that could interfere with walking assessment
- Severe systemic diseases other than diabetes or its complications, especially those interfering with exercise tolerance
- Amputation in the lower extremities
- Terminal illness
- Severe obesity: BMI>30 kg/m2 (33)
- Severe foot deformities (e.g. flexion contracture of the toes, pes cavus, Charcot disease)
- Mini-mental status of <27 or diagnosis of dementia
- History of alcohol or drug abuse
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:防止
- 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 |
---|---|
他の:1
|
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 |
---|
Plantar Pressure
|
協力者と研究者
捜査官
- 主任研究者:Karen Perell, PhD RKT、VA Greater Los Angeles Healthcare System, West LA
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。