- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03570268
Preventing Falls and Participation Restrictions in Neurological Diseases
Educational and Exercise Intervention to Prevent Falls and Participation Restrictions in Subjects With Neurological Diseases
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Milan, Italia, 20148
- Fondazione Don Gnocchi ONLUS
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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:
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
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Participants in the experimental intervention group received an educational program and tailored home exercises.
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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.
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Participants allocated to the control group received stretching exercises.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change of Percentage of fallers
Tidsramme: Change from Baseline percentage of fallers at 6 months.
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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".
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Change from Baseline percentage of fallers at 6 months.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Change of Participation level
Tidsramme: Change from Baseline partecipation at 6 months.
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The patient (or, if unavailable, the spouse or an informed caregiver) was inquired on partecipation level.
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Change from Baseline partecipation at 6 months.
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Hjernesykdommer
- Sykdommer i sentralnervesystemet
- Sykdommer i immunsystemet
- Demyeliniserende autoimmune sykdommer, CNS
- Autoimmune sykdommer i nervesystemet
- Demyeliniserende sykdommer
- Autoimmune sykdommer
- Parkinsonlidelser
- Basal ganglia sykdommer
- Bevegelsesforstyrrelser
- Synukleinopatier
- Nevrodegenerative sykdommer
- Multippel sklerose
- Parkinsons sykdom
- Sykdommer i nervesystemet
Andre studie-ID-numre
- RF-2010-2318552
Legemiddel- og utstyrsinformasjon, studiedokumenter
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