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Evaluation of a Wearable Exoskeleton for Functional Arm Training

21. december 2018 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

28

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University School of Medicine

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Preeti Raghavan, MD, New York University Medical School

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. juni 2015

Primær færdiggørelse (Faktiske)

5. maj 2016

Studieafslutning (Faktiske)

5. maj 2016

Datoer for studieregistrering

Først indsendt

17. marts 2016

Først indsendt, der opfyldte QC-kriterier

28. marts 2016

Først opslået (Skøn)

1. april 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. december 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. december 2018

Sidst verificeret

1. december 2018

Mere information

Begreber relateret til denne undersøgelse

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 .

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