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Evaluation of Gait Performance in Children With Neuromuscular Diagnoses

4. november 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

72

Kontakter og lokationer

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

Studiesteder

  • Schweiz
      • Affoltern am Albis, Schweiz, CH-8910
        • University Children's Hospital Zurich, Rehabilitation Center

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

6 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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
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.
Andet: Gait rehabilitation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
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
Foranstaltningsbeskrivelse
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.
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.
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
Foranstaltningsbeskrivelse
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.
The WeeFIM-Item Locomotion (Walking) is scored by the primary nurse.
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.
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.
Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.
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.
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.
Participants will be followed for the duration of the rehabilitation stay, an expected average of 12 weeks, with only one measurement at discharge.

Samarbejdspartnere og efterforskere

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

Sponsor

University Children's Hospital, Zurich

Efterforskere

  • Ledende efterforsker: Corinne Ammann-Reiffer, MPTSc, University Children's Hospital Zurich, Rehabilitation Center Affoltern

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

1. april 2014

Primær færdiggørelse (Faktiske)

31. januar 2016

Studieafslutning (Faktiske)

31. januar 2016

Datoer for studieregistrering

Først indsendt

1. september 2014

Først indsendt, der opfyldte QC-kriterier

8. september 2014

Først opslået (Skøn)

11. september 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • GaitPerformance_2014

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Gait rehabilitation

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner