- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02237222
Evaluation of Gait Performance in Children With Neuromuscular Diagnoses
4. november 2020 oppdatert av: University Children's Hospital, Zurich
Evaluation of the Gait Performance Measures 'Functional Mobility Scale' and 'Gillette Functional Assessment Questionnaire' in Children With Neuromuscular Diagnoses
The aims of this project are to evaluate the psychometric properties of the German versions of the two performance questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette Functional Assessment Questionnaire - walking scale' (GFAQ) in children between 6-18 years with a neuromuscular diagnosis.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
The German versions of the two questionnaires 'Functional Mobility Scale' (FMS) and 'Gillette Functional Assessment Questionnaire - walking scale' (GFAQ) are evaluated in terms of construct validity, inter- and intra-rater reliability as well as responsiveness in children with a neuromuscular diagnosis, who absolve an inpatient stay in the rehabilitation center of the University Chilren's Hospital Zurich, Switzerland.
Studietype
Observasjonsmessig
Registrering (Faktiske)
72
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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-
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Affoltern am Albis, Sveits, CH-8910
- University Children's Hospital Zurich, Rehabilitation Center
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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
6 år til 18 år (Barn, Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Children with neuromuscular diagnoses, who are inpatients in the rehabilitation center of the University Children's Hospital Zurich in Affoltern am Albis.
Beskrivelse
Inclusion Criteria:
- Neuromuscular diagnosis
- Age: 6-18 years
- Rehabilitation goal = improvement of walking abilities
Exclusion Criteria:
- Children's whose parents are not German-speaking
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 |
Intervensjon / Behandling |
|---|---|
|
Gait rehabilitation
Multi-modal therapy program including physiotherapy with the aim of gait improvement, Lokomat or treadmill training, strength training, sports therapy. Frequency and intensity are individually assigned. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Mobility Scale (FMS)
Tidsramme: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
|
Gillette Functional Assessment Questionnaire - Walking Scale (GFAQ)
Tidsramme: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
The questionnaire is filled in independently by the parents, the primary nurse as well as the physiotherapist of each child.
|
Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Global Rating Scale (GRS)
Tidsramme: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
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A global rating on the perceived change of the child's functional mobility over the rehabilitation period and whether this change is perceived as meaningful or not; on a 5-point Likert scale, scored by the parents and the physiotherapist.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Independence Measure for Children (WeeFIM)
Tidsramme: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
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The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with measurements at admission and discharge.
|
|
10-Meter Walk Test (10MWT)
Tidsramme: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
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For the evaluation of the construct validity of the FMS and the GFAQ, the 10MWT comfortable speed as well as maximal speed will be performed shortly before discharge on a 14-meter long track with standardized instructions.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
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6-Minute walk test (6MinWT)
Tidsramme: Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
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For the evaluation of the construct validity of the FMS and the GFAQ, the 6MinWT is performed shortly before discharge on a 30-meter long track with standardized instructions.
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Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Corinne Ammann-Reiffer, MPTSc, University Children's Hospital Zurich, Rehabilitation Center Affoltern
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
1. april 2014
Primær fullføring (Faktiske)
31. januar 2016
Studiet fullført (Faktiske)
31. januar 2016
Datoer for studieregistrering
Først innsendt
1. september 2014
Først innsendt som oppfylte QC-kriteriene
8. september 2014
Først lagt ut (Anslag)
11. september 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
5. november 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. november 2020
Sist bekreftet
1. november 2020
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- GaitPerformance_2014
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