- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02855853
Study of the Impact of Implicit Motor Training in a Rehabilitation Programme in Frail Elderly Subjects (MAAMI)
Study of the Impact of Implicit Motor Training Using a Virtual Reality System and Serious Games on a Tablet Computer in a Rehabilitation Programme in Frail Elderly Subjects
Even though cognitive-motor performances are impaired in frail elderly subjects compared with healthy elderly subjects, exercising cognitive-motor processes in an implicit manner can improve the carrying out of real actions in everyday life.
No training programme using virtual reality and serious games oriented towards the perception/action system has been tested in frail elderly subjects.
The expected results are:
- In the short term, greater strengthening of motor and cognitive abilities in subjects trained with the virtual reality and serious games, thanks to stimulation through action and through the underlying processes.
- In the long term (+1 and +3 months at the end of the training period) better preservation of motor and cognitive abilities in subjects who took part in the virtual reality and serious games programme.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Dijon, Frankrig, 21079
- Rekruttering
- CHU Dijon Bourgogne
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Kontakt:
- Patrick MANCKOUNDIA
- Telefonnummer: 33 03 80 29 39 70
- E-mail: patrick.manckoundia@chu-dijon.fr
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
Patients :
- Who have provided oral consent
- Enrolled in a geriatric rehabilitation programme
- Qualified as cognitively frail, that is to say a MiniMental State Examination (MMSE) score between 15 and 28 and/or for motor abilities, a walking speed less than 0.65 m/s.
- Aged ≥ 65 years
- Able to understand simple instructions
Exclusion Criteria:
Patients:
- Not covered by national health insurance
- With an extremely low cognitive status (MMSE < 15)
- With severely impaired vision and audition (unable to discern any sensory information from the virtual reality system: music, sounds, images)
- Who are unstable when standing
- With an unsteady gait (risk of falling)
- Who cannot walk at least 10 metres
- With an acute non-stabilized cardiovascular disease
- With one or several non-consolidated fractures.
- Under guardianship
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Placebo komparator: styring
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Eksperimentel: serious game
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Improvement in performance at the Timed Up and Go (TUG) in the group taking part in the implicit motor training programme compared with a group having conventional motor training.
Tidsramme: Change from baseline at Day0 and after 6 weeks of training
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Change from baseline at Day0 and after 6 weeks of training
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MANCKOUNDIA ANR 2012
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