- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02088255
Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers
7. marts 2016 opdateret af: Gabriela Lopes Gama, Universidade Cruzeiro do Sul
Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Individuals With Hemiparesis Due to Stroke
The purpose of this study is evaluate the effects of walking training with partial body weight support on static (floor) and dynamic (treadmill) surfaces in individuals with hemiparesis due to stroke.
For this purpose, two training protocols will be employed in three experimental groups: G1 will do the walking training with partial body weight support on static surfaces and G2 will do the walking training with partial body weight support on dynamic surfaces
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
28
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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São Paulo, Brasilien
- Cruzeiro do Sul University
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
40 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- One-sided hemiparesis, No heart disease (or medical clearance to participate in the study), No orthopedic impairments and / or neurological symptoms that may alter the the gait, no history of thrombophlebitis or deep vein thrombosis, Ability to understand and follow verbal commands, Can walk alone or with canes of approximately 10 m; Spasticity degree mild to moderate in the affected lower limb with levels of classification between 0 and 2 in the Ashworth spasticity scale modified
Exclusion Criteria:
- Heart frequency increase more than 75% of the maximum or have any other general instability during training that may lead risk for the health during the training,
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Static surface
The subjects will do the walking training with partial body weight support on static surface.
The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions
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During all session time the subject will walk on the floor with partial body weight support.
This protocol will be repeated in all sessions.
Andre navne:
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Aktiv komparator: dynamic surface
The subjects will do the walking training with partial body weight support on dynamic surface.
The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions
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During all session time the subject will walk on the treadmill with partial body weight support.
This protocol will be repeated in all sessions.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change from Baseline in the gait velocity
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Speed at which subjects walked measured by the 10 meters test
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Baseline, immediately after and six weeks after training cessation.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Distribution of body weight
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Body weight Distribution measured while subjects are in a static position on two force platforms.
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Baseline, immediately after and six weeks after training cessation.
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Functional independence
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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a score was assigned for each everyday activity, according to the amount of assistance required to perform it.
Measured by a clinical scale (Functional Independence Measure Scale.
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Baseline, immediately after and six weeks after training cessation.
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Lower limb recovery
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Measured by a clinical scale (Fulgy Meyer).
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Baseline, immediately after and six weeks after training cessation.
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Endurance
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Measured by the 6 minutes walking test
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Baseline, immediately after and six weeks after training cessation.
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Spacial and temporal variables
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Measured while subjects are walking at a comfortable speed
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Baseline, immediately after and six weeks after training cessation.
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Center of Pressure
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Behavior of the Center of Pressure in gait and gait initiation measured by the force plates during the gait and gait initiation.
Center of Pressure distance and seed displacement will be measured during the task.
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Baseline, immediately after and six weeks after training cessation.
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articular and segment angles
Tidsramme: Baseline, immediately after and six weeks after training cessation.
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Measured while subjects are walking at a comfortable speed
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Baseline, immediately after and six weeks after training cessation.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2014
Primær færdiggørelse (Faktiske)
1. juli 2015
Studieafslutning (Faktiske)
1. juli 2015
Datoer for studieregistrering
Først indsendt
10. marts 2014
Først indsendt, der opfyldte QC-kriterier
13. marts 2014
Først opslået (Skøn)
14. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
8. marts 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. marts 2016
Sidst verificeret
1. juli 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CE/UCS-016/2013
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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