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Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.

27. september 2021 opdateret af: Marmara University

Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Transtibial and Transfemoral Amputes.

With the onset of prosthesis use following lower extremity amputations,body shows biomechanical changes according to the amputation level and consequently develops adaptation mechanisms both on the healthy and ampute side. Adaptations in the lumbo-pelvic and lower lumbar regions cause asymmetries in the muscle tissue by causing changes in the morphological structure of the muscle, especially in the muscles of the waist, hip and knee and recruitment.

The aim of this study is to investigate the effect of stairing up and down activity on the mechanical properties of lumbal paravertebral muscles in TFA and TTA and its relation with lower lumbar region pain.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

28

Kontakter og lokationer

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

Studiesteder

  • Kalkun
      • Istanbul, Kalkun, 34000
        • Yasar Tatar

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 55 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Unilateral transfemoral and transtibial amputate patients

Beskrivelse

Inclusion Criteria:

  • to be TTA and TFA
  • No complaints of chronic low back pain before amputation
  • Using prosthesis for at least 6 months
  • Being able to climb up and down stairs
  • No history of falls that will cause injury or pain in the past 6 months
  • Having good prosthesis comfort
  • BMI<28.5
  • Who can have cognitive functions to understand Arabic language

Exclusion Criteria:

  • To be amputated due to congenital and tumor
  • Who can not have cognitive functions to understand Arabic language
  • Having orthopedic or neurological disorders that may cause chronic pain or functional impairment in the lumbar region
  • Ankylosing spondolitis and rheumatoid arthritis patients

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group 1

Transtibial amputation

The patients will be asked to go up and down 9-step stair with the highest speed they can make.
Andet: Group 1
The patients will be asked to go up and down 9-step stair with the highest speed they can make.
Group 2

Transfemoral amputation

The patients will be asked to go up and down 9-step stair with the highest speed they can make.
Andet: Group 2
The patients will be asked to go up and down 9-step stair with the highest speed they can make.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the mechanical properties of the muscle-1
Tidsramme: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Viscoelastic stiffness [N/m] will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the mechanical properties of the muscle-2
Tidsramme: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Oscillation frequency (Hz) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the mechanical properties of the muscle-3
Tidsramme: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Mechanical stiffness (N/m) will be measured in MyotonPro 3 (MYO, Tallin, Estonia
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the back pain
Tidsramme: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Pain will be evaluated by using Visual analog scale ranging 0 (no pain)- 10 (worst pain)
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
Evaluation of the pressure-pain threshold
Tidsramme: Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity
The pressure-pain threshold (lbs) will be measured in algometer commander (JTECH MEDICAL, MM036_K, 2016)
Change from Baseline mechanical properties at following staring up and down activity, at 10 minutes after the staring up and down activity

Samarbejdspartnere og efterforskere

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

Sponsor

Marmara University

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 (Faktiske)

1. februar 2020

Primær færdiggørelse (Faktiske)

15. april 2020

Studieafslutning (Faktiske)

20. december 2020

Datoer for studieregistrering

Først indsendt

24. marts 2020

Først indsendt, der opfyldte QC-kriterier

25. marts 2020

Først opslået (Faktiske)

27. marts 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. oktober 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. september 2021

Sidst verificeret

1. september 2021

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 09.2019.969

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Kliniske forsøg med Stair up and Down, Amputation

Kliniske forsøg med Group 1

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