Walking Training With Partial Body Weight Support on Static and Dynamic Surfaces in Stroke Survivers
7 mars 2016 uppdaterad av: 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
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
28
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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São Paulo, Brasilien
- Cruzeiro do Sul University
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / 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.
Andra namn:
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change from Baseline in the gait velocity
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Distribution of body weight
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Spacial and temporal variables
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2014
Primärt slutförande (Faktisk)
1 juli 2015
Avslutad studie (Faktisk)
1 juli 2015
Studieregistreringsdatum
Först inskickad
10 mars 2014
Först inskickad som uppfyllde QC-kriterierna
13 mars 2014
Första postat (Uppskatta)
14 mars 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
8 mars 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 mars 2016
Senast verifierad
1 juli 2015
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CE/UCS-016/2013
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .