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Augmentation of Locomotor Adaptation Post-Stroke

26. juni 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

29

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • MUSC Center for Rehabilitation Research in Neurologic Conditions

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria: Chronic Stroke

  1. age 18-70
  2. at least six month post-stroke
  3. residual paresis in the lower extremity (Fugl-Meyer LE motor score <34)
  4. ability to sit unsupported for ≥ 30 sec
  5. ability to walk at least 10 ft.
  6. self-selected 10 meter gait speed < 0.8 m/s
  7. provision of informed consent.

Exclusion Criteria: Acute Stroke

  1. Unable to ambulate at least 150 feet prior to stroke, or experienced intermittent claudication while walking < 200 meters
  2. history of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
  3. History of COPD or oxygen dependence
  4. Preexisting neurological disorders, dementia or previous stroke
  5. History of major head trauma
  6. Legal blindness or severe visual impairment
  7. history of significant psychiatric illness
  8. Life expectancy <1 yr
  9. Severe arthritis or orthopedic problems that limit passive ROM
  10. post-stroke depression (PHQ-9 ≥10)
  11. History of DVT or pulmonary embolism within 6 months
  12. Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
  13. Severe hypertension with systolic >200 mmHg and diastolic >110 mmHg at rest
  14. presence of cerebellar stroke.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Eksperimentel: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Center of Mass Acceleration Peak
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Center of Mass Acceleration Impulse
Tidsramme: 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.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Self-selected walking speed
Tidsramme: 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
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Mark G Bowden, PhD, PTf, Ralph H. Johnson VA Medical Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Faktiske)

31. marts 2018

Studieafslutning (Faktiske)

31. marts 2018

Datoer for studieregistrering

Først indsendt

3. maj 2016

Først indsendt, der opfyldte QC-kriterier

7. september 2016

Først opslået (Skøn)

8. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med tDCS

3
Abonner