Rectus Femoris Thickness Measurement in Unilateral Transtibial Amputated Prosthesis Users
6. februar 2020 oppdatert av: Kardelen Gencer Atalay, Marmara University
Relation Between Ultrasonographic Rectus Femoris Thickness Measurement and Functionality in Unilateral Transtibial Amputated Prosthesis Users
Knee extension strengthening is one of the cornerstones of rehabilitation in prosthesis users with transtibial amputation.
It is recommended in terms of increasing functional mobility, preventing the risk of fall and knee osteoarthritis.
Therefore, there is a need for objective measurements to evaluate changes in functional strength and walking through the rehabilitation process.
Muscle thickness measured by ultrasound was found to be valid and highly correlated with magnetic resonance imaging and dual-energy X-ray absorptiometry measurements and shown to reflect the strength and functional outcomes in various diseases.
The first aim of this study is to reveal the rectus femoris muscle thickness alteration in prosthesis users with transtibial amputation compared to able-bodied controls and establish its correlation with functional strength and walking tests.
The second aim is to determine intra- and inter-rater reliability and construct validity of the rectus femoris muscle thickness measured by ultrasound in prosthesis users with transtibial amputation.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Bilateral rectus femoris muscle thickness was measured by two independent examiners using an ultrasound.
Bilateral knee extension strength was measured via handheld dynamometer (Jamar, Bolingbrook, IL, USA).
Functional strength and walking were assessed by Step-up-over (SUO) and Walk-across (WA) tests of NeuroCom Balance Master® device (NeuroCom International, Clackamas, OR, USA).
Studietype
Observasjonsmessig
Registrering (Faktiske)
28
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Istanbul, Tyrkia, 34899
- Marmara University
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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
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Prosthesis users with transtibial amputation and their age-, sex- and dominancy-matched (1:1) able-bodied controls to provide an amputation-independent reference were included.
Beskrivelse
Inclusion Criteria:
- Unilateral transtibial amputation on the right side
- Using the prosthesis for more than 1 year
- Able to use the prosthesis without pain and discomfort
- Able to walk without a walking aid
Exclusion Criteria:
- Presence of concomitant health issues (diabetes mellitus, peripheral artery disease, and other vascular diseases etc.)
- Ongoing pathology with the contralateral or residual limb (pressure sore or ulcer etc.)
- Taking medication that is known to affect balance
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Prosthesis users
Prosthesis users with transtibial amputation
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Able-bodied Controls
Prosthesis users' age-, sex- and dominancy-matched healthy controls
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Ultrasonographic cross-sectional area of rectus femoris measurement
Tidsramme: through study completion, an average of 6 months
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Images were obtained at the bulkiest area of muscle at mid-thigh (midway between the anterior superior iliac spine and the upper pole of the patella) while the participant lay in the supine position with lower limbs are extended and relaxed.
The probe was held axially with a light touch in order not to cause any difference in the muscle volume.
The rectus femoris cross-sectional area of both limbs (CSA-RF) (mm2) was calculated.
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through study completion, an average of 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Knee extension strength measurement via handheld dynamometer
Tidsramme: through study completion, an average of 6 months
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The dynamometer was located 5 cm above the intermalleolar line to measure bilateral knee extension strength.
All participants were tested while lying supine position with a support behind the knees to achieve approximately 30° of flexion.
For the amputated-limb, the prosthesis was used in place.
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through study completion, an average of 6 months
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Step-up-over Test
Tidsramme: through study completion, an average of 6 months
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All participants were asked to stand still behind the box placed on the pressure platform and to move immediately after seeing the sign on the computer screen.
The movement was defined as three phases: first stepping onto the box with one limb, second carrying the body over the box, and third landing with the other limb on the opposite side of the box.
The average lift-up index (%), movement time (s), and the impact index for both limbs calculated after three repetitions.
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through study completion, an average of 6 months
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Walk-across Test
Tidsramme: through study completion, an average of 6 months
|
All participants were asked to stand still and to walk as fast as possible along with the pressure platform after seeing the sign on the computer screen.
The average step width (cm), step length (cm), and speed (cm/s) were calculated after three repetitions.
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through study completion, an average of 6 months
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Samarbeidspartnere og etterforskere
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Sponsor
Etterforskere
- Hovedetterforsker: Kardelen Gencer Atalay, Marmara University
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)
1. oktober 2018
Primær fullføring (Faktiske)
1. april 2019
Studiet fullført (Faktiske)
1. mai 2019
Datoer for studieregistrering
Først innsendt
6. februar 2020
Først innsendt som oppfylte QC-kriteriene
6. februar 2020
Først lagt ut (Faktiske)
10. februar 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09.2018.025
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