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A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

5. november 2020 oppdatert av: Tam Pham, University of Washington

Virtual-Environment Home Rehabilitation: a Randomized Controlled Trial

The overarching goal for this prospective randomized controlled trial (PRCT) is to determine whether a virtual-environment, home-rehabilitation program improves functional outcomes for individuals after a burn injury. Specifically, this study will test the efficacy of a technology-assisted rehabilitation program against current standard of home therapy.

Studieoversikt

Status

Ukjent

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a prospective, randomized controlled trial (PRCT) involving 50 adult burn survivors. This study tests the efficacy of a technology-assisted rehabilitation program against current standard of home therapy. There are two study groups for which subjects will be randomized: control and experimental.The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. The experimental group receives treatment as usual, in addition to training and use of the Jintronix platform for 3 months after hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

Studietype

Intervensjonell

Registrering (Forventet)

50

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
    • Washington
      • Seattle, Washington, Forente stater, 98104
        • Rekruttering
        • Harborview Medical Center
        • Ta kontakt med:
          • Gretchen J Carrougher, MN
          • Telefonnummer: 206-744-2866
          • E-post: carrough@uw.edu
        • Ta kontakt med:

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:

  • Age greater than or equal to 18 years old (no upper age limit)
  • Ability to provide written, informed consent for study participation
  • Ability to read and understand English
  • Anticipated discharge to home environment

  • Home environment includes access to:

    • television (larger than 20 inches in diameter with High Definition Multimedia Interface input (HDMI)
    • internet and email address
    • telephone (cell phone or landline)

Exclusion Criteria:

  • Age less than 18 years
  • Inability to provide written, informed consent for study participation
  • Inability to read or understand English
  • Delirium (as determined by the Delirium Observation Score test)
  • Near-fall event at time of screening
  • Pregnant women
  • Discharge to non-home environment (e.g., shelter, street, skilled nursing facility)

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: technology-assisted rehabilitation
The experimental group will receive treatment as usual, in addition to training with the Jintronix platform. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.
Atferdsmessig: Technology-assisted rehabilitation
The Jintronix software platform, coupled with the Microsoft Kinect for movement capture, contains individualized exercise modules to increase ROM, endurance and strength. Within this PRCT, online monitoring of activity and actigraphy measurements through a wearable device and completion of an online diary will provide enhanced monitoring of home activities.
Aktiv komparator: Usual care
The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.
Atferdsmessig: Usual care
The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Level of physical activity
Tidsramme: 3 months after study enrollment
level of activity among enrolled subjects by actigraphy
3 months after study enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Range of motion (ROM)
Tidsramme: Study enrollment, 3, 6 and 12 months after enrollment
ROM by subjects in each group
Study enrollment, 3, 6 and 12 months after enrollment
Patient-reported outcome measures (PROMIS): sleep
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Sleep and sleep disturbance Short Form (SF)8B PROMIS tool
Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): social participation
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Participation in social roles and activities PROMIS tool SF6A
Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): pain interference
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Pain interference PROMIS tool SF6A
Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): fatigue
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Fatigue PROMIS tool SF6A
Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): stiffness
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Stiffness impact Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-ME) V2.0
Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): mobility
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Mobility PROMIS tool
Study enrollment, 3, 6, 12 months after enrollment
Patient-reported outcome measures (PROMIS): upper extremity
Tidsramme: Study enrollment, 3, 6, 12 months after enrollment
Upper extremity PROMIS SF7A
Study enrollment, 3, 6, 12 months after enrollment
Return to work/school
Tidsramme: up to 1 year
Date when subject returns to work or school
up to 1 year
Patient reported level of activity difficulty
Tidsramme: Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment
Using 1-5 difficulty scale (1=no difficulty and 5=very difficult), subject is asked how difficult his/her activity has been for the past 2 days
Weekly beginning 1 week after study enrollment and concluding 3 months after study enrollment

Samarbeidspartnere og etterforskere

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

Sponsor

University of Washington

Etterforskere

  • Hovedetterforsker: Tam Pham, MD, University of Washington

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)

8. februar 2018

Primær fullføring (Forventet)

30. september 2021

Studiet fullført (Forventet)

30. september 2022

Datoer for studieregistrering

Først innsendt

1. mars 2018

Først innsendt som oppfylte QC-kriteriene

22. mars 2018

Først lagt ut (Faktiske)

23. mars 2018

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00003707

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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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