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Preventing Falls and Participation Restrictions in Neurological Diseases

15. juni 2018 opdateret af: Fondazione Don Carlo Gnocchi Onlus

Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases

A randomized open clinical trial to assess the added value of a comprehensive rehabilitation program on fall prevention and improve participation and activities of daily living. Baseline assessment, 6-month experimental intervention (experimental group) vs. usual rehabilitation programs and assessment at end of treatment and six months after treatment will be performed.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

90 patients will be randomly patients will be stratified by disease type and randomized separately.

The trial will be organized in Baseline assessment (clinical characteristics; fall predictors, chosen among the variables found to predict falls in the observational study), experimental intervention (experimental group) vs. usual rehabilitation programs (control group) and assessment at end of treatment and six months after treatment.

The aim of the treatment will be the prevention of falls.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

90

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Italien
      • Milan, Italien, 20148
        • Fondazione Don Gnocchi ONLUS

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

Patients with stroke, Parkinson's disease and Multiple Sclerosis residing in the centers' catchment areas, requiring rehabilitation, and releasing a written informed consent.

Exclusion Criteria:

1. Cognitive impairment (Minimental State Examination score <21); 2. Major depression; 3. Severe joint/bone disorder interfering with mobility, 4. Aphasia if interfering with understanding the aims of the study and self-administered tests; 5. relapses in the previous three months (MS); 6. Stroke occurred in least four weeks before study entry.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group: Education group
Participants in the experimental intervention group (education group) received an educational program and tailored home exercises. This intervention consist of multiple, interacting components supported by a handbook and audio-video material designed to teach people the skills, techniques, and strategies for preventing falls, and increase social participation and engagement in inactivity of daily living. . After the educational session, two one hour sessions were spent to teach safe balance exercises that were developed in preceding studies, the patient was invited to perform at home for 2 months.
Andet: Experimental Group: Education
Participants in the experimental intervention group received an educational program and tailored home exercises.
Aktiv komparator: Control Group: Usual care
Participants allocated to the control group received ongoing usual treatments. In addition, two one hour lessons were spent to teach stretching exercises that the patient was invited to perform at home for 2 months.
Andet: Control Group: Usual care
Participants allocated to the control group received stretching exercises.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of Percentage of fallers
Tidsramme: Change from Baseline percentage of fallers at 6 months.
Each patient was given a fall diary and was followed for six months with telephone contacts for six months. The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on targeted rehabilitation programs received during the follow up, the use of walking aid and any incurred falls, with date, circumstances, underlying cause and related injuries. A fall was defined as an unexpected event where the person inadvertently came to rest on the ground or other lower level subjects with >1 falls in the 6 months follow up were categorized as "faller".
Change from Baseline percentage of fallers at 6 months.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change of Participation level
Tidsramme: Change from Baseline partecipation at 6 months.
The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.
Change from Baseline partecipation at 6 months.

Samarbejdspartnere og efterforskere

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

Sponsor

Fondazione Don Carlo Gnocchi Onlus

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 (Faktiske)

1. januar 2015

Primær færdiggørelse (Faktiske)

30. december 2016

Studieafslutning (Faktiske)

15. januar 2017

Datoer for studieregistrering

Først indsendt

25. maj 2018

Først indsendt, der opfyldte QC-kriterier

15. juni 2018

Først opslået (Faktiske)

26. juni 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juni 2018

Sidst verificeret

1. april 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RF-2010-2318552

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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 Experimental Group: Education

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner