- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00983450
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-Brain-Stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
The Influences of Watching a Movie Clip of Normal Walking on Measurable Walking Parameters Among Post-brain-stroke Patients as Opposed to the Influences of a Control Movie Clip Showing Backwards Walking
The study will include 20 subjects who will be randomly divided to two groups: a ten person group being the study group and a ten person group acting as a control group (each group will include a similar number of females and males as the other group). In addition, the physiotherapy treatments at the rehabilitation center, the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends). The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles. Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention. Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
The person performing the examinations will be blinded as to the division of the subjects to the study group and the control group. After performing the previously noted examinations needed to participate in the research, the subjects found fit will be examined before the beginning of the intervention, at its end and then three months after its conclusion. The examinations will include smart step and walking parameters.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Očekávaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Jerusalem, Izrael
- Hadassah University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
- A FAC (Functional Ambulation Category) score test result of 2 or 3, in order to ensure basic mobility, even if still requiring supervision.
- A NIHSS (National Institutes of Health Stroke Scale) score of 3 to 18.
Patients suffering from the following will not be part of the study:
- Significant neglect (a BIT score under 129 in the conventional tests).
- Hemianopsy as determined upon a clinical examination by a rehabilitation physician.
- Clarity of vision problem, determined upon an SC based examination.
- Significant cognitive decline (a Mini mental test score of under 24).
- Aphasia which prevents understanding the signing a Helsinki form.
Exclusion Criteria:
- Patients participating in concurrent researches will not participate
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: study group
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
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the study group will gain an intervention consisting of 12 therapy sessions, administered for 12 consecutive days (apart of weekends).
The intervention will include 6 minutes of watching a movie clip alternately showing a healthy man and a healthy woman at their sixties, walking while being filmed from various angles.
Immediately after watching, the subject will perform 6 minutes of walking, under the experimenters supervision, but without his or hers intervention.
Immediately following the walking, the whole procedure will be repeated (watching a clip and walking).
|
Experimentální: CONTROL
People after a first ischemic or hemorrhagic stroke, up to 60 days following the event.
|
The control group will undergo 12 treatments of the same nature, but will watch the movie clip shown backwards, so that the people filmed will seem to walk backwards (it was established that watching a reversed action does not activate the MNS system activated by a regular execution of the activity [Celnik et al., 2008]), followed by 6 minutes of walking under the experimenters supervision, then watching the movie again and walking again.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
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Smart step examination- Average weight on the hind foot and fore foot. Cycle - time (in seconds) from one initial contact to the other (on the same foot). Stance and swing average percentage of one walking cycle, Cadence
Časové okno: before the beginning of the intervention, at its end and then three months after its conclusion.
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before the beginning of the intervention, at its end and then three months after its conclusion.
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Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
2. Two min. walking test. 3. Ten meter walking test. 4. An ABC questioner to determine the personal confidence in regards to walking.
Časové okno: before the beginning of the intervention, at its end and then three months after its conclusion.
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before the beginning of the intervention, at its end and then three months after its conclusion.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Zeev meiner, M.D, Hadassah Medical Organization
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Kardiovaskulární choroby
- Cévní onemocnění
- Cerebrovaskulární poruchy
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Mrtvice
- Fyziologické účinky léků
- Neurotransmiterové látky
- Molekulární mechanismy farmakologického působení
- Hormony
- Hormony, hormonální náhražky a antagonisté hormonů
- Adrenokortikotropní hormon
- Melanocyty stimulující hormony
- beta-endorfin
Další identifikační čísla studie
- 0303-09-HMO
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