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Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

20. april 2017 opdateret af: Yong-Tae Lee, Spaulding Rehabilitation Hospital
The overall objective of the study is to test whether the use of small electrical currents to stimulate proprioceptors of the upper limb has potential for improving robot-assisted upper-limb rehabilitation in stroke survivors.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Study participants will be instructed to perform upper-limb movements using a system designed for upper-limb rehabilitation (Armeo Spring by Hocoma AG). The system provides subjects with unloading of the stroke-affected arm thus facilitating the performance of upper-limb movements. The system will be used to track the movements of the stroke-affected arm. Simultaneously, a custom-designed system (a prototype developed by the investigators) will be used to deliver small electrical currents to the arm. We hypothesize that the currents delivered to the arm will improve the accuracy of the movements performed by study participants.

To assess if delivering small currents to the arm has an effect on the accuracy of the movements performed by the study participants, they will receive actual stimulation for some trials and sham stimulation for other trials. Because the investigators will deliver very small currents, study participants will be unable to perceive such currents and hence tell if they are performing the movements while receiving actual or sham stimulation. By comparing trials performed while subjects receive actual stimulation with trials performed while subjects received sham stimulation, the investigators will determine if the stimulation has an effect on the accuracy of the movements performed by the subjects.

It is worth noticing that the investigators collected primary outcome data to assess changes associated with the use of actual stimulation vs sham stimulation. Data during a follow-up session was also collected, but not for the purpose of collecting outcome measures.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02129
        • Spaulding Rehabilitation Hospital Boston

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:

  • unilateral and cortical, subcortical, or cerebellar stroke
  • 6 months post-stroke
  • Upper extremity impairments but able to move upper extremity against gravity 25% of the range
  • Ability to understand directions and follow simple instructions
  • Medically stable
  • Upper Extremity Fugl-Meyer between 28 and 55
  • At least four (4) months since last botox treatment
  • Mini-Mental State Examination (MMSE) ≥ 23

Exclusion Criteria:

  • Participation in other forms of therapy/ intervention for upper extremity motor recovery
  • Upper extremity or trunk fractures
  • Severe fixed contractures affecting the upper limbs
  • Severe perceptual deficits or visual field impairments
  • Severe cognitive deficits
  • Pregnant women
  • Presence of an implanted electrically operated medical device
  • Evidence of more than one clinical stroke
  • Serious medical or neurological illness
  • History of head trauma or cerebral infectious disease

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: Current stimulator
The investigators have developed a device to deliver very small currents to the arm. The device will be used while subjects perform upper-limb movements using a device for upper-limb rehabilitation. Subjects will perform multiple trials of movement. During half of the trials, they will receive actual stimulation. During the other half, they will receive sham stimulation.
Enhed: Current stimulator
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fugl-Meyer Assessment
Tidsramme: Changes in Fugl-Meyer Assessment score with vs without stimulation
Subjects are asked to perform upper-limb movements from which a therapist can assess the severity of movement abnormalities (e.g. flexion synergies)
Changes in Fugl-Meyer Assessment score with vs without stimulation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Jebsen-Taylor Hand Function Test
Tidsramme: Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Subjects are asked to perform a set of functional movements from which a therapist can assess subjects' functional limitations
Changes in Jebsen-Taylor Hand Function Test score with vs without stimulation
Motor Activity Log
Tidsramme: Change in Motor Activity Log score with vs without stimulation
Subjects are asked about the amount and quality of use of their stroke-affected arm during the performance of daily activities
Change in Motor Activity Log score with vs without stimulation
Modified Ashworth Scale
Tidsramme: Change in Modified Ashworth Scale score with vs without stimulation
A therapist examines subjects to assess the severity of spasticity
Change in Modified Ashworth Scale score with vs without stimulation
Box and Block test
Tidsramme: Change in Box and Block test score with vs without stimulation
Subjects are asked to move as many small wooden blocks as possible from one to box to another in a set amount of time
Change in Box and Block test score with vs without stimulation
Grip strength
Tidsramme: Change in grip strength with vs without stimulation
A hand dynamometer is used to measure grip strength
Change in grip strength with vs without stimulation

Samarbejdspartnere og efterforskere

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

Sponsor

Spaulding Rehabilitation Hospital

Samarbejdspartnere

Wyss Institute at Harvard University
Center for Integration of Medicine & Innovative Technology

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 (Faktiske)

1. august 2011

Primær færdiggørelse (Faktiske)

1. juli 2013

Studieafslutning (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først indsendt

10. september 2012

Først indsendt, der opfyldte QC-kriterier

17. september 2012

Først opslået (Skøn)

21. september 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. april 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. april 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2011-P-001592

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Overlevende af kronisk slagtilfælde

Kliniske forsøg med Current stimulator

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