- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01640899
Insoles Effect on Pain and Daily Activities
The Effect of Shoe Insoles on Pain and Daily Activities and the Relation Between Satisfaction With Insoles and Use: A pre-and Post-intervention Survey
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Pain in weight-bearing joints limits individual's function and ability to perform daily activities, causes a negative effect on productivity and increased costs for social insurance. This pain is often the outcome of structural deformities or work-related foot pain often occurs in workers whose occupations include standing or walking for a long time.
One of the most common reasons for prescribing insoles is to enhance functioning by reducing nonspecific pain in the foot, leg or low back pain. Reduction of pain is expected to improve quality of life in daily activities such as work and recreational activities.
Persons actual use of the insoles, is a prerequisite for any effect it may have. It can be hypothesized that the use of the insoles is related to what the user thinks about their comfort, appearance, the amount of foot perspiration they induce, and other factors.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Orebro County
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Orebro, Orebro County, Sverige, 701 85
- Dept. of Prosthetics and Orthotics, Orebro University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Pain in lower extremities
- Aged 18 years or older
- Able to speak Swedish.
Exclusion Criteria:
- Pain due to a systemic or progressive disease
- Use of orthosis of other type than insoles
- Earlier foot surgery or current use of prosthesis.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: Single-arm study
This is a single-arm study.
Just one group (i.e. the patients)
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Shoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities.
The insoles give a mechanical support for the body by put it in a good alignment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Shoe insoles effect on pain level in lower extremities.
Tidsramme: Four-weeks follwo up period
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The participants answer the inetial questioniners before getting the insoles, then answr the same questionnier after four weeks of insoles use.
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Four-weeks follwo up period
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Shoe insoles effect on daily activities
Tidsramme: Four-weeks follow up period
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The participants answer Inetnational Physical Activty Questionnier (IPAQ)and Lower Extremity Functional Status (LEFS)before getting the insoles and after four weeks of use.
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Four-weeks follow up period
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Satisfaction with shoe insoles use
Tidsramme: After four weeks of use
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Client Satisfaction with Device(CSD)survey was anwered by the participants after four weeks of use.
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After four weeks of use
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Ahmed Amer, Master, Centre for Rehabilitation Reserach, Örebro
- Studieleder: Liselotte Norling-Hermansson, PhD, Dept. of Prosthetics and Orthotics, Örebro University Hospital, Örebro
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- CRR120709
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