Augmentation of Locomotor Adaptation Post-Stroke
2018年6月26日 更新者：Medical University of South Carolina
This project will evaluate two different methods of normalizing the center of mass acceleration (COMa) in individuals post-stroke, specifically focusing on rates and pattern of recovery to analyze walking-specific adaptations as precursors to motor learning.
In addition, the proposed project seeks to establish the optimal configuration of electrodes to activate neural circuits involved in post-stroke locomotion.
Once the better method of training COMa and optimal parameters of electrode placement for tDCS are identified, the investigators will evaluate the effects of tDCS on locomotor adaptations during single sessions and over a five-day training period.
調査の概要
詳細な説明
The project seeks to establish the optimal configuration of electrodes to change the excitability of neural circuits involved in post-stroke locomotion, identify effective strategies for training a specific locomotor adaptation, and improve adaptations via adjunctive non-invasive brain stimulation.
Tools to improve neural excitability may increase potential for locomotor skill learning, thereby improving rehabilitation outcomes.
Non-invasive brain stimulation with transcranial direct current stimulation (tDCS) has recently emerged as a simple to administer, low-cost, and low-risk option for stimulating brain tissue.
Cortical excitability is increased after application and preliminary results imply a relationship to increases in motor activity in those post-stroke.
However, inhibition of the contralesional hemisphere is also shown to improve paretic motor output through inhibition of excessive maladaptive strategies, and combining the two electrode configurations may provide additional benefit for locomotor tasks requiring interlimb coordination.
Furthermore, the effects of tDCS on walking function in conjunction with physical intervention strategies aimed at improving locomotor ability post-stroke are yet unstudied.
研究の種類
介入
入学 (実際)
29
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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South Carolina
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Charleston、South Carolina、アメリカ、29425
- MUSC Center for Rehabilitation Research in Neurologic Conditions
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria: Chronic Stroke
- age 18-70
- at least six month post-stroke
- residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
- ability to sit unsupported for ≥ 30 sec
- ability to walk at least 10 ft.
- self-selected 10 meter gait speed < 0.8 m/s
- provision of informed consent.
Exclusion Criteria: Acute Stroke
- Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters
- history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
- History of COPD or oxygen dependence
- Preexisting neurological disorders, dementia or previous stroke
- History of major head trauma
- Legal blindness or severe visual impairment
- history of significant psychiatric illness
- Life expectancy <1 yr
- Severe arthritis or orthopedic problems that limit passive ROM
- post-stroke depression (PHQ-9 ≥10)
- History of DVT or pulmonary embolism within 6 months
- Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
- Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest
- presence of cerebellar stroke.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Uphill COMa training
Walking on an inclined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
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Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain.
Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.
Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham "stimulation" will include zero current.
Evaluating immediate effects during 20 minutes walking on a treadmill.
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実験的：Downhill COMa training
Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
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Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain.
Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.
Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham "stimulation" will include zero current.
Evaluating immediate effects during 20 minutes walking on a treadmill.
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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 |
|---|---|---|
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Center of Mass Acceleration Peak
時間枠：Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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Peak full body center of mass acceleration during gait, expressed as m/sec^2, captured during 30 seconds of treadmill walking at a steady-state, self-selected walking speed.
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Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Center of Mass Acceleration Impulse
時間枠：Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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Positive integral of the full body center of mass acceleration during the gait cycle, expressed as an average over all strides captured during 30 seconds of data collection at a steady-state, self-selected walking speed (m/sec).
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Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Self-selected walking speed
時間枠：Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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Walking speed overground for 10 meters, average of 3 timed trials, expressed as m/sec.
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Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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Paretic step ratio
時間枠：Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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Percentage of the total stride completed by paretic step.
This is a unit-less measure.
Each stride is initiated by foot strike of the paretic leg, and the data are expressed as an average over all strides captured during 30 seconds of data collection at a steady-state, self-selected walking speed.
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Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Mark G Bowden, PhD, PTf、Ralph H. Johnson VA Medical Center
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Reis J, Schambra HM, Cohen LG, Buch ER, Fritsch B, Zarahn E, Celnik PA, Krakauer JW. Noninvasive cortical stimulation enhances motor skill acquisition over multiple days through an effect on consolidation. Proc Natl Acad Sci U S A. 2009 Feb 3;106(5):1590-5. doi: 10.1073/pnas.0805413106. Epub 2009 Jan 21.
- Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.
- Fregni F, Boggio PS, Mansur CG, Wagner T, Ferreira MJ, Lima MC, Rigonatti SP, Marcolin MA, Freedman SD, Nitsche MA, Pascual-Leone A. Transcranial direct current stimulation of the unaffected hemisphere in stroke patients. Neuroreport. 2005 Sep 28;16(14):1551-5. doi: 10.1097/01.wnr.0000177010.44602.5e.
- Reis J, Fritsch B. Modulation of motor performance and motor learning by transcranial direct current stimulation. Curr Opin Neurol. 2011 Dec;24(6):590-6. doi: 10.1097/WCO.0b013e32834c3db0.
- Paulus W. Transcranial direct current stimulation (tDCS). Suppl Clin Neurophysiol. 2003;56:249-54. doi: 10.1016/s1567-424x(09)70229-6.
- Devanne H, Lavoie BA, Capaday C. Input-output properties and gain changes in the human corticospinal pathway. Exp Brain Res. 1997 Apr;114(2):329-38. doi: 10.1007/pl00005641.
- Boggio PS, Nunes A, Rigonatti SP, Nitsche MA, Pascual-Leone A, Fregni F. Repeated sessions of noninvasive brain DC stimulation is associated with motor function improvement in stroke patients. Restor Neurol Neurosci. 2007;25(2):123-9.
- Hummel F, Cohen LG. Improvement of motor function with noninvasive cortical stimulation in a patient with chronic stroke. Neurorehabil Neural Repair. 2005 Mar;19(1):14-9. doi: 10.1177/1545968304272698.
- Jeffery DT, Norton JA, Roy FD, Gorassini MA. Effects of transcranial direct current stimulation on the excitability of the leg motor cortex. Exp Brain Res. 2007 Sep;182(2):281-7. doi: 10.1007/s00221-007-1093-y. Epub 2007 Aug 24.
- Bowden MG, Behrman AL, Woodbury M, Gregory CM, Velozo CA, Kautz SA. Advancing measurement of locomotor rehabilitation outcomes to optimize interventions and differentiate between recovery versus compensation. J Neurol Phys Ther. 2012 Mar;36(1):38-44. doi: 10.1097/NPT.0b013e3182472cf6.
- Bowden MG, Clark DJ, Kautz SA. Evaluation of abnormal synergy patterns poststroke: relationship of the Fugl-Meyer Assessment to hemiparetic locomotion. Neurorehabil Neural Repair. 2010 May;24(4):328-37. doi: 10.1177/1545968309343215. Epub 2009 Sep 30.
- Brandell BR. Functional roles of the calf and vastus muscles in locomotion. Am J Phys Med. 1977 Apr;56(2):59-74.
- Kim DY, Lim JY, Kang EK, You DS, Oh MK, Oh BM, Paik NJ. Effect of transcranial direct current stimulation on motor recovery in patients with subacute stroke. Am J Phys Med Rehabil. 2010 Nov;89(11):879-86. doi: 10.1097/PHM.0b013e3181f70aa7.
- Lay AN, Hass CJ, Gregor RJ. The effects of sloped surfaces on locomotion: a kinematic and kinetic analysis. J Biomech. 2006;39(9):1621-8. doi: 10.1016/j.jbiomech.2005.05.005. Epub 2005 Jun 28.
- Leroux A, Fung J, Barbeau H. Postural adaptation to walking on inclined surfaces: II. Strategies following spinal cord injury. Clin Neurophysiol. 2006 Jun;117(6):1273-82. doi: 10.1016/j.clinph.2006.02.012. Epub 2006 Apr 27.
- Leroux A, Fung J, Barbeau H. Postural adaptation to walking on inclined surfaces: I. Normal strategies. Gait Posture. 2002 Feb;15(1):64-74. doi: 10.1016/s0966-6362(01)00181-3.
- Shah B, Nguyen TT, Madhavan S. Polarity independent effects of cerebellar tDCS on short term ankle visuomotor learning. Brain Stimul. 2013 Nov;6(6):966-8. doi: 10.1016/j.brs.2013.04.008. Epub 2013 May 17.
- Peterson CL, Cheng J, Kautz SA, Neptune RR. Leg extension is an important predictor of paretic leg propulsion in hemiparetic walking. Gait Posture. 2010 Oct;32(4):451-6. doi: 10.1016/j.gaitpost.2010.06.014. Epub 2010 Jul 24.
- Roberts DR, Ramsey D, Johnson K, Kola J, Ricci R, Hicks C, Borckardt JJ, Bloomberg JJ, Epstein C, George MS. Cerebral cortex plasticity after 90 days of bed rest: data from TMS and fMRI. Aviat Space Environ Med. 2010 Jan;81(1):30-40. doi: 10.3357/asem.2532.2009.
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- Tanaka S, Hanakawa T, Honda M, Watanabe K. Enhancement of pinch force in the lower leg by anodal transcranial direct current stimulation. Exp Brain Res. 2009 Jul;196(3):459-65. doi: 10.1007/s00221-009-1863-9. Epub 2009 May 29.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年4月1日
一次修了 (実際)
2018年3月31日
研究の完了 (実際)
2018年3月31日
試験登録日
最初に提出
2016年5月3日
QC基準を満たした最初の提出物
2016年9月7日
最初の投稿 (見積もり)
2016年9月8日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月28日
QC基準を満たした最後の更新が送信されました
2018年6月26日
最終確認日
2018年6月1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。