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Evaluation of a Wearable Exoskeleton for Functional Arm Training

21. desember 2018 oppdatert av: NYU Langone Health

Evaluation of a Wearable Exoskeleton for Functional Arm Training (CAREX)

The purpose of this study is to investigate how the cable-driven arm exoskeleton (CAREX) can assist task performance during 3D arm movement tasks under various experimental conditions in healthy individuals and patients with stroke. This study is designed to test motor learning with the robotic rehabilitative device CAREX under three conditions in healthy subjects and subjects with post-stroke hemiparesis.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

28

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • New York
      • New York, New York, Forente stater, 10016
        • New York University School of Medicine

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 til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria for stroke population:

  • Radiologically verified unilateral stroke at least 4 months previously.
  • Right-handed subjects with or without right hemiparesis (as robot is built for right arm alone).
  • Preserved passive range of motion at all upper limb joints.
  • Spasticity <3 on the modified Ashworth Scale (MAS).
  • Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.

Exclusion Criteria for stroke population.

  • History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
  • Previous neurological illness such as head trauma, prior stroke ( as we are recruiting subjects with first unilateral stroke), epilepsy, or demyelinating disease.
  • Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
  • Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
  • Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.

Inclusion Criteria for control population.

  • No previous stroke or any other previous neurological injury.
  • Right-handed subjects without any weakness or hemiparesis (as robot is built for right arm alone).
  • Preserved passive and active range of motion at all upper limb joints.
  • No increase in muscle tone in response to passive range of motion. A score of zero on Ashworth Scale (MAS).
  • Able to achieve full score on upper extremity Fugl-Meyer Scale (66/66)
  • Ability to follow study instructions and likely to complete the protocol; ability to comply with the protocol as assessed by the investigator; must be English speaking since the assessments are in English.

Exclusion Criteria for control population.

  • History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
  • Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
  • Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
  • Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Healthy Subjects
Seven healthy patients will serve as controls based on preliminary data in healthy volunteers using CAREX with gravity elimination alone versus gravity elimination plus path assistance.
CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
CAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path
Aktiv komparator: Chronic Post Stroke Right Side Hemiparesis
Radiologically verified unilateral stroke patients with at least 4 months previously.
CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
CAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Passive range of motion measured by goniometry
Tidsramme: 1 Day
1 Day
Active range of motion measured by goniometry
Tidsramme: 1 Day
1 Day
Upper extremity motor impairment measured by performance on the 33 tasks of the Fugl-Meyer Scale (FMS)
Tidsramme: 1 Day
1 Day
Spasticity measured by the Modified Ashworth Scale (MAS)
Tidsramme: 1 Day
1 Day

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Preeti Raghavan, MD, New York University Medical School

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. juni 2015

Primær fullføring (Faktiske)

5. mai 2016

Studiet fullført (Faktiske)

5. mai 2016

Datoer for studieregistrering

Først innsendt

17. mars 2016

Først innsendt som oppfylte QC-kriteriene

28. mars 2016

Først lagt ut (Anslag)

1. april 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. desember 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. desember 2018

Sist bekreftet

1. desember 2018

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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