- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04324788
Investigation of the Effect of Stair Activity on Lumbal Paravertebral Mechanical Properties in Amputes.
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
-
Istanbul, Tyrkia, 34000
- Yasar Tatar
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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. |
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. |
The patients will be asked to go up and down 9-step stair with the highest speed they can make.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Kelly-Martin R, Doughty L, Garkavi M, Wasserman JB. Reliability of modified adheremeter and digital pressure algometer in measuring normal abdominal tissue and C-section scars. J Bodyw Mov Ther. 2018 Oct;22(4):972-979. doi: 10.1016/j.jbmt.2018.02.017. Epub 2018 Feb 17.
- Devan H, Hendrick P, Ribeiro DC, Hale LA, Carman A. Asymmetrical movements of the lumbopelvic region: is this a potential mechanism for low back pain in people with lower limb amputation? Med Hypotheses. 2014 Jan;82(1):77-85. doi: 10.1016/j.mehy.2013.11.012. Epub 2013 Nov 16.
- Hendershot BD, Bazrgari B, Nussbaum MA. Persons with unilateral lower-limb amputation have altered and asymmetric trunk mechanical and neuromuscular behaviors estimated using multidirectional trunk perturbations. J Biomech. 2013 Jul 26;46(11):1907-12. doi: 10.1016/j.jbiomech.2013.04.018. Epub 2013 May 29.
- Highsmith MJ, Kahle JT, Kaluf B, Miro RM, Mengelkoch LJ, Klenow TD. PSYCHOMETRIC EVALUATION OF THE HILL ASSESSMENT INDEX (HAI) AND STAIR ASSESSMENT INDEX (SAI) IN HIGH-FUNCTIONING TRANSFEMORAL AMPUTEES. Technol Innov. 2016 Sep;18(2-3):193-201. doi: 10.21300/18.2-3.2016.193.
- Hu X, Lei D, Li L, Leng Y, Yu Q, Wei X, Lo WLA. Quantifying paraspinal muscle tone and stiffness in young adults with chronic low back pain: a reliability study. Sci Rep. 2018 Sep 25;8(1):14343. doi: 10.1038/s41598-018-32418-x.
- Michaud SB, Gard SA, Childress DS. A preliminary investigation of pelvic obliquity patterns during gait in persons with transtibial and transfemoral amputation. J Rehabil Res Dev. 2000 Jan-Feb;37(1):1-10.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 09.2019.969
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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. .
Kliniske studier på Group 1
-
Uludag UniversityFullført
-
Shengjing HospitalRekruttering
-
Ayşegül İşler DalgıçHorizonHar ikke rekruttert ennåStress, følelsesmessig | Helserisikoatferd | Helserelatert atferd | Sunn livsstil | Mangel på fysisk aktivitet | Sunn ernæring | Indeks for sunt kosthold | Ikke-smittsomme sykdommerTyrkia
-
Al-Azhar UniversityFullførtKlasse II feilslutningEgypt
-
RenJi HospitalHar ikke rekruttert ennåVæskerespons | Slagvolumvariasjon | SVV-FloTrac | Thorax elektrisk bioimpedansKina
-
RenJi HospitalHar ikke rekruttert ennåVæskerespons | Slagvolumvariasjon | SVV-FloTrac | Thorax elektrisk bioimpedansKina
-
AdventHealthAdventist UniversityFullførtSvimmelhetForente stater
-
University of MinnesotaArizona State UniversityFullført
-
University of MichiganReuben Phoenix Schostak Fontan Wellness Project FundRekrutteringSkrøpelighet | Fontan fysiologi | Enkeltventrikkel hjertesykdomForente stater
-
Jordi Gol i Gurina FoundationUkjentSubacromial Impingement SyndromeSpania