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Wheelchair Mobility Assessment of Individuals With Spinal Cord Injury

21. juli 2014 opdateret af: Mark S. Nash, Ph.D., FACSM, University of Miami

Wheelchair Propulsion Function and Physical Capacity in Persons With Spinal Cord Injury

The specific aims of this study are: 1) to assess the test-retest reliability of a modification of an existing wheelchair propulsion assessment and 2) validate the modification against traditional measures of physical strength, power, and endurance in a group of persons with spinal cord injury (SCI).

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

The ability to independently self-propel and transfer oneself is a crucial component of daily life for individuals with a spinal cord injury. This ability is related in part to an individual's strength, power, and endurance, but it is unknown which of these measures is most important to achieve a high level of wheelchair function. Identification of which physical performance parameters are best related to wheeled mobility performance is essential in developing interventions to improve said performance. Currently, clinic-friendly assessments of a person's wheeled mobility ability do not exist. We have developed a modified, clinic-friendly version of validated wheelchair mobility assessment that can be completed in most clinics. Before it can be implemented by clinicians its reliability must be established. Crossvalidating it against standard measures of physical performance will allow for the identification of the most appropriate exercise interventions to improve independent wheeled mobility.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

62

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33136
        • The Miami Project to Cure Paralysis

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 og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Community sample

Beskrivelse

Inclusion Criteria:

  • Spinal Cord Injury
  • American Spinal Injury Association Impairment Scale (AIS) A-D
  • Self-reported ability to self-propel themselves in a manual wheelchair
  • Age 18 or older

Exclusion Criteria:

  • surgery within 6 months
  • pressure ulcer within 3 months
  • upper limb pain that limits completion of exercise
  • recurrent acute infection or illness requiring hospitalization or IV antibiotics
  • pregnancy
  • previous myocardial infarction or cardiac surgery

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Ability Score
Tidsramme: within a 14 day period
The ability score is the sum of the number of items successfully completed in the wheelchair propulsion assessment. There are 8 items in the assessement, which will be completed in the following order: 1) Figure of 8 Shape, 2) Doorstep Crossing, 3) Platform Ascent, 4) 15 meter sprint, 5) Ramp Ascent (5% grade), 6) Ramp Ascent (8% grade), 7) 150 meter propulsion, and 8) Timed Level Transfer.
within a 14 day period

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Muscular strength
Tidsramme: 1 day
Upper extremity dynamic strength testing will be performed on a Helms equalizer 1000 multi-station exerciser using the following maneuvers: overhead press, horizontal row, vertical butterfly, biceps curl, latissimus pull down (either to the chest or neck), and dips. The 1-repetition maximum (1-RM) will be calculated using the Mayhew regression equation.
1 day
Anaerobic power
Tidsramme: 1 day
Participants will propel a table-mounted Monark 894e ergometer for 30 seconds at maximal speed against constant force. The constant resistance for each subject will be set at 1.5% and 3.5% of their body mass, for tetraplegia and paraplegia respectively. Data for three variables will be obtained: a) peak power, defined as the highest average mechanical power measured during any 5-second period, b) mean power, the average power sustained during the 30-second test period, and c) rate of fatigue, defined as the degree of power drop-off during the test.
1 day
Cardiovascular endurance
Tidsramme: 1 day
Endurance will be measured using a calibrated upper arm ergometer. An initial exercise workload of 0 Watts at 60 revolutions per minute (RPM) for three minutes will be followed by three minute stages increasing in 20 Watt increments. Responses to exercise will be continuously monitored via open-circuit spirometry and 12-lead electrocardiography. Peak Work will be defined as volitional fatigue, inability to maintain targeted workload, or the point at which increasing workload fails to further increase VO2.
1 day

Samarbejdspartnere og efterforskere

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

Sponsor

University of Miami

Efterforskere

  • Ledende efterforsker: Mark S Nash, PhD, University of Miami Miller School of Medicine, The Miami Project to Cure Paralysis

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 2008

Primær færdiggørelse (Faktiske)

1. februar 2012

Studieafslutning (Faktiske)

1. februar 2012

Datoer for studieregistrering

Først indsendt

16. september 2010

Først indsendt, der opfyldte QC-kriterier

16. september 2010

Først opslået (Skøn)

17. september 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

22. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juli 2014

Sidst verificeret

1. juli 2014

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TMP-MN-007

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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Sponsorer og samarbejdspartnere

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Betingelser

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Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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