Augmentation of Locomotor Adaptation Post-Stroke
26. Juni 2018 aktualisiert von: 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.
Studienübersicht
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
29
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
South Carolina
-
Charleston, South Carolina, Vereinigte Staaten, 29425
- MUSC Center for Rehabilitation Research in Neurologic Conditions
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 85 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Uphill COMa training
Walking on an inclined 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.
|
|
Experimental: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Center of Mass Acceleration Peak
Zeitfenster: Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
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.
|
Pre (same as initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Center of Mass Acceleration Impulse
Zeitfenster: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
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).
|
Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Self-selected walking speed
Zeitfenster: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
Walking speed overground for 10 meters, average of 3 timed trials, expressed as m/sec.
|
Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
|
Paretic step ratio
Zeitfenster: Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
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.
|
Pre (directly prior to initial session) and post (immediately following final session) conducted within 5-10 days apart according to subject availability.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Mark G Bowden, PhD, PTf, Ralph H. Johnson VA Medical Center
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. April 2013
Primärer Abschluss (Tatsächlich)
31. März 2018
Studienabschluss (Tatsächlich)
31. März 2018
Studienanmeldedaten
Zuerst eingereicht
3. Mai 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
7. September 2016
Zuerst gepostet (Schätzen)
8. September 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
28. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
26. Juni 2018
Zuletzt verifiziert
1. Juni 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 16060
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .