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Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (ROTS)

15. oktober 2020 opdateret af: University of Sao Paulo General Hospital
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks.

Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone.

We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment.

Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later.

The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone.

Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

9

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Brasilien
    • SP
      • São Paulo, SP, Brasilien, 05403900
        • Hospital das Clinicas

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
  • Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
  • Ability to provide written informed consent (patient ou legal representative)
  • Ability to comply with the schedule of interventions and evaluations in the protocol.

Exclusion Criteria:

  • Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 on the Modified Ashworth Spasticity Scale.
  • Upper limb plegia
  • Uncontrolled medical problems such as end-stage cancer or renal disease
  • Pregnancy
  • Seizures, except for a single seizure during the first week post stroke
  • Pacemakers
  • Other neurological disorders such as Parkinson's disease
  • Psychiatric illness including severe depression
  • Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
  • Hemineglect
  • Drugs that interfere on cortical excitability, except for antidepressants
  • Cerebellar lesions

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active tDCS + robotic therapy + physical therapy

Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes.

Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Enhed: Robotterapi
Robotterapi (MIT - Manus, Interactive Motion Technologies) vil blive administreret i 40 minutter til den paretiske overekstremitet.
Enhed: Active tDCS
Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Andet: Physical Therapy
Physical therapy will be administered for 40 minutes.
Aktiv komparator: sham tDCS + robotic therapy + physical therapy

Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes.

Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Enhed: Robotterapi
Robotterapi (MIT - Manus, Interactive Motion Technologies) vil blive administreret i 40 minutter til den paretiske overekstremitet.
Andet: Physical Therapy
Physical therapy will be administered for 40 minutes.
Enhed: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.
Eksperimentel: sham tDCS + physical therapy + occupational therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
Andet: Physical Therapy
Physical therapy will be administered for 40 minutes.
Enhed: Sham tDCS
In sham tDCS, no current will be delivered through the tDCS device.
Andet: Occupational Therapy
Occupational therapy will be administered for 40 minutes.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Upper Extremity Fugl Meyer Assessment
Tidsramme: 6 weeks from baseline
Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
6 weeks from baseline
Percentage of Sessions With Adverse Events
Tidsramme: Post treatment (6 weeks from baseline).
Post treatment (6 weeks from baseline).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Modified Rankin Scale
Tidsramme: 6 weeks from baseline
Scores range from 0 to 6. Higher scores indicate greater severity.
6 weeks from baseline
Change in National Institutes of Health Stroke Scale
Tidsramme: 6 weeks from baseline
Scores range from 0 to 42. Higher scores indicate greater severity.
6 weeks from baseline
Change in Stroke Impact Scale
Tidsramme: 6 weeks from baseline
Scores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life. The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
6 weeks from baseline
Number of Participants Who Presented Score on Modified Ashworth Scale >2
Tidsramme: 6 weeks
Scores range from 0 to 4, with 5 choices. A score of 1 indicates no resistance, and 4 indicates rigidity.
6 weeks
Change in Motor Activity Log
Tidsramme: 6 weeks from baseline
Each domain contains taks scored on 0 to 5 ordinal scale. Lower scores indicate greater severity.
6 weeks from baseline
Upper Extremity Fugl Meyer Assessment
Tidsramme: 6 months follow-up
Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
6 months follow-up
Number of Participants With Adverse Events
Tidsramme: 6 months follow-up
6 months follow-up
Change in Fatigue Severity Scale
Tidsramme: 6 weeks from baseline

Fatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale.

The total score range from 9 to 63 points. Higher scores indicate greater fatigue.
6 weeks from baseline
Change in Pittsburgh Sleep Quality Index
Tidsramme: 6 weeks from baseline
The global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
6 weeks from baseline

Samarbejdspartnere og efterforskere

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

Sponsor

University of Sao Paulo General Hospital

Samarbejdspartnere

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Efterforskere

  • Ledende efterforsker: Adriana B Conforto, MD Phd, University of Sao Paulo

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. juni 2015

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

20. februar 2015

Først indsendt, der opfyldte QC-kriterier

9. april 2015

Først opslået (Skøn)

15. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. oktober 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. oktober 2020

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 513.207

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