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Improving Recovery After Stroke Via Electrical Stimulation of Proprioceptors

20. april 2017 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Faktiske)

1

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02129
        • Spaulding Rehabilitation Hospital Boston

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: 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.
Enhet: Current stimulator
This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Spaulding Rehabilitation Hospital

Samarbeidspartnere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2011

Primær fullføring (Faktiske)

1. juli 2013

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

10. september 2012

Først innsendt som oppfylte QC-kriteriene

17. september 2012

Først lagt ut (Anslag)

21. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2011-P-001592

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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