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A Prospective Study to Evaluate Use of the Tibion Bionic Leg in Sub-Acute Post-stroke Patients (Acute Effects)

5. juli 2012 opdateret af: Tibion Bionics, Inc.

A Prospective, Experimental ABA Study to Evaluate Use of the Tibion Bionic Leg in Subacute Post-stroke Patients Undergoing Physical Therapy

The objective of this clinical study is to examine acute changes in stability, force allocation, work, and mobility from using a wearable, portable, battery-operated robotic orthosis (the Tibion Bionic Leg) in subacute post-stroke persons undergoing lower extremity physical therapy.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Samples text.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

10

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19102
        • Magee Rehabilitation Hospital

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

40 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Single stroke with residual unilateral lower-extremity weakness
  • Subacute post-stroke period (>3 and <12 months)
  • Eligible to participate to lower extremity physical therapy
  • Age 40 years or greater
  • Able to ambulate at least 10 meters
  • Able to ambulate without a leg brace
  • Ambulation speed less than 0.8 meters/second
  • Minimum to moderate assist for transfer or ambulation by physical therapist evaluation
  • Subject must understand the nature of the study and provide written informed consent prior to enrollment.
  • Subject must be willing and able to attend all study sessions

Exclusion Criteria:

  • Medically unstable
  • Age younger than 40 years
  • Acute post-stroke (< 3 months)
  • Chronic post-stroke (> 12 months)
  • Status-post multiple strokes
  • Status-post traumatic brain injury
  • Ambulation speed greater than 0.8 meters/second
  • Currently using a Knee-Ankle-Foot Orthosis (KAFO)
  • Not eligible for lower extremity physical therapy
  • Concomitant degenerative neurological conditions
  • Not able to ambulate at least 10 meters without assistance
  • Greater than moderate assist during transfer or ambulation by physical therapist evaluation
  • Unable to ambulate without a leg brace
  • Unable to follow instructions, complete follow-up, or provide informed consent.
  • Currently enrolled in another investigational device or drug trial

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Tibion Arm
Arm of the study in which enrolled subacute post-stroke subjects undergo lower extremity physical therapy using the Tibion Bionic Leg.
Enhed: Tibion Bionic Leg
The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ambulation Speed
Tidsramme: Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.
Walking speed (comfortable and fastest possible), in meters per second, as measured by the 10 Meter Walk Test (10 MWT).
Baseline (prior to training); at conclusion of training regimen, an average of 2 weeks.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurements of Gait
Tidsramme: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.

The secondary endpoints are obtained from the GAITRite analysis system:

  • Measurements of gait, such as the length and time of step, cycle, and stride, Heel to Heel base support, single/double limb support time, and stance and swing phase timing.
Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Measurements of Stride
Tidsramme: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.

Other secondary endpoints are obtained from the GAITRite analysis system:

  • Measurements of Stride such as distance, ambulation time, velocity, normalized velocity, cadence, step time, step length, cycle time.
Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.
Measurements of Force, Stance, and Stability
Tidsramme: Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.

Other secondary endpoints are obtained from Balance Master system:

  • Limb parameters, including force in transfers from sitting to standing, standing to sitting, weight-bearing squats, and limits of stability.
Baseline (prior to training); prior to the first training session; prior to the second training session; at the conclusion of training regimen completed an average of 2 weeks.

Samarbejdspartnere og efterforskere

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

Sponsor

Tibion Bionics, Inc.

Efterforskere

  • Ledende efterforsker: Barbara Browne, MD, Magee Rehabilitation Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. marts 2012

Primær færdiggørelse (Forventet)

1. august 2012

Studieafslutning (Forventet)

1. august 2012

Datoer for studieregistrering

Først indsendt

6. marts 2012

Først indsendt, der opfyldte QC-kriterier

16. marts 2012

Først opslået (Skøn)

20. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CP001

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 Tibion Bionic Leg

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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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