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Balance Recovery and Training on Fall Prevention in Stroke

13. september 2005 oppdatert av: National Taiwan University Hospital

The specific aims of this research are delineated as the following: Aim 1: To investigate the neuromuscular and biomechanical mechanisms of the emerging processes of proactive and reactive balance control during sitting and standing in patients with stroke at different stages of the recovery course. Aim 2: To determine the relationships between brain lesion sites and the recovery patterns of reactive and proactive balance control mechanisms in patients with stroke. Aim 3: To determine the relationships between the impairments in reactive and proactive balance control mechanisms and functional outcome as well as fall incidence in patients following stroke. Aim 4: To investigate the efficacy of different training regimens in improving reactive and proactive balance control strategies and in preventing falls in stroke patients with different brain lesion sites. Principally, three hypotheses are to be tested: Hypothesis 1:The emerging processes and recovery patternes of proactive and reactive balance control may be different among stroke patients with different brain lesion locations. Hypothesis 2:There are positive correlations between the level of impairments in reactive and proactive balance control mechanisms and functional outcome as well as fall incidence in patients following stroke. Hypothesis 3:Training regimens that could best facilitate the emergence or improvement in reactive and proactive balance control strategies are different.

Studieoversikt

Status

Ukjent

Forhold

Slag

Intervensjon / Behandling

Atferdsmessig: Balanse og trening

Detaljert beskrivelse

Stroke is one of the leading causes of chronic disability in the world. Falls are one of the primary complications after stroke. The incidence of falls ranges from 25% to 75% among stroke patients residing in different settings, with greater incidence of falls occurring after discharge home. Postural instability has been suggested as one of the main causes leading to falls in this population. The recovery of the ability to maintain balance during activities of daily living, therefore, is essential for functional independence and safety of these patients. In the following paragraphs, the knowledge gaps taht we are proposing to bridge in this study and the revelant literature that leads us to identify these gaps are discussed.

Studietype

Intervensjonell

Registrering

100

Fase

Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Taiwan
- - Taipei, Taiwan, 100
    - Rekruttering
    - School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
    - Ta kontakt med:
      
      Pei-Fang Tang, PhD
      
      Telefonnummer: 7557 +886-2-23123456
      
      E-post: pftang@ntu.edu.tw

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

45 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Healthy adults

between 45 and 75 years old
having no neuromuscular or musculoskeletal disorders that would jeopardize their balance control abilities
being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Stroke patients

between 45 and 75 years old
hemiplegic or hemiparetic as a result of a single cerebral vascular accident with brain lesions primarily involving one of the following areas: the primary motor cortex, supplementary motor/premotor areas, parietal cortex, or basal ganglia
medically stable with no ongoing complications
within 30 days post stroke able to independently sit without using any assistive device for at least 3 minutes if being tested on the 14th and 30th days post-stroke and able to stand and take a fast step independently in standing without using any assistive device for at least 3 minutes when tested on the 60th, 90th, 180th, 360th, 540th, and 720th days post stroke onset
able to communicate with the experimenters
having no hemianopsia or any obvious cognitive problems as evaluated with the Mini-Mental State examination
being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital

Exclusion Criteria:

having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal disorders, or disorders from systematic diseases other than stroke

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Utdanning/Rådgivning/Opplæring
Tildeling: Ikke-randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Ingen (Open Label)

Hva måler studien?

Primære resultatmål

Resultatmål
For å undersøke balansegjenoppretting (proaktive posturale justeringer og reaktiv postural reaksjon) etter utbruddet av hvert hjerneslag.

Sekundære resultatmål

Resultatmål
For å undersøke forekomsten av fall før og etter trening

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

National Taiwan University Hospital

Samarbeidspartnere

National Health Research Institutes, Taiwan

Etterforskere

Hovedetterforsker: Pei-Fang Tang, PhD, National Taiwan Unversity Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2002

Studiet fullført

1. desember 2007

Datoer for studieregistrering

Først innsendt

12. september 2005

Først innsendt som oppfylte QC-kriteriene

13. september 2005

Først lagt ut (Anslag)

14. september 2005

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)