- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03402360
Virtual Reality Rehabilitation in Patients With Acquired Brain Injury
Effectiveness of Virtual Environment Rehabilitation in Patients With Acquired Brain Injury: Clinical Randomized Controlled Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
MI
-
Milan, MI, Italien, 20132
- Ircss Ospedale San Raffaele
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Acquired Brain Injury within 1 month before the recruitment;
- Score between 0 and 3 at the Motor Arm subscore of the Italian version of the National Institutes of Health Stroke Scale (it-NIHSS);
- Score between 9 and 15 at the Glasgow Coma Scale for the traumatic brain injury Acquired Brain Injury.
Exclusion Criteria:
- Denial of informed consent;
- Visual deficits that interfere with the virtual reality rehabilitation;
- Score under 18 at the Mini Mental State Examination;
- Severe orthopedic deficit;
- Patients with pace maker;
- Patients with contraindication to undergo magnetic resonance;
- Pregnant women.
Studieplan
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: Virtual Reality rehabilitation group
The Virtual Reality group will perform upper extremity motor rehabilitation and neurocognitive rehabilitation based on virtual reality training.
|
Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: virtual reality upper extremity motor rehabilitation 1 hour: virtual reality neurocognitive training |
Aktiv komparator: Control group
The Control group will perform the same motor and neurocognitive rehabilitation but with the virtual reality turned off.
|
Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks). 1 hour: conventional physiotherapy 1 hour: upper extremity motor rehabilitation 1 hour: neurocognitive training |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Fugl-Meyer Upper Extremity (FMUE)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Items are scored on a 3-point ordinal scale 0 = cannot perform; 1 = performs partially; 2 = performs fully. Maximum Score = 66 points |
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Action Research Arm Test (ARAT)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Change in Functional Independence Measures (FIM)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Change in Mini Mental State Examination (MMSE)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Change in Montreal Cognitive Assessment (MoCA)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Change in Beck Depression Inventory (BDI)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Change in 36-Item Short Form Survey (SF-36)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Andre resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Resting state functional MRI (fMRI)
Tidsramme: From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
From Baseline (T0) to 3 weeks of rehabilitation (T1)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VR-ABI
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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