Augmentation of Locomotor Adaptation Post-Stroke
26 juin 2018 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
29
Phase
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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South Carolina
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Charleston, South Carolina, États-Unis, 29425
- MUSC Center for Rehabilitation Research in Neurologic Conditions
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 85 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: Downhill COMa training
Walking on a declined treadmill, thus manipulating the permissive environment to elicit COMa adaptation, while receiving either tDCS or sham tDCS.
|
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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Center of Mass Acceleration Peak
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Center of Mass Acceleration Impulse
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Self-selected walking speed
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Mark G Bowden, PhD, PTf, Ralph H. Johnson VA Medical Center
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- Schlaug G, Renga V, Nair D. Transcranial direct current stimulation in stroke recovery. Arch Neurol. 2008 Dec;65(12):1571-6. doi: 10.1001/archneur.65.12.1571.
- 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.
- Tanaka S, Takeda K, Otaka Y, Kita K, Osu R, Honda M, Sadato N, Hanakawa T, Watanabe K. Single session of transcranial direct current stimulation transiently increases knee extensor force in patients with hemiparetic stroke. Neurorehabil Neural Repair. 2011 Jul-Aug;25(6):565-9. doi: 10.1177/1545968311402091. Epub 2011 Mar 24.
- Turns LJ, Neptune RR, Kautz SA. Relationships between muscle activity and anteroposterior ground reaction forces in hemiparetic walking. Arch Phys Med Rehabil. 2007 Sep;88(9):1127-35. doi: 10.1016/j.apmr.2007.05.027.
- Werner C, Lindquist AR, Bardeleben A, Hesse S. The influence of treadmill inclination on the gait of ambulatory hemiparetic subjects. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):76-80. doi: 10.1177/1545968306289958.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2013
Achèvement primaire (Réel)
31 mars 2018
Achèvement de l'étude (Réel)
31 mars 2018
Dates d'inscription aux études
Première soumission
3 mai 2016
Première soumission répondant aux critères de contrôle qualité
7 septembre 2016
Première publication (Estimation)
8 septembre 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
28 juin 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 juin 2018
Dernière vérification
1 juin 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 16060
Plan pour les données individuelles des participants (IPD)
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