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Body Weight Support Training on Ground Level (BWSGR)

26. marts 2010 opdateret af: Universidade Federal de Sao Carlos

Ground-level Partial Body Weight Support Gait Training for Individuals With Chronic Stroke

The purpose of this study was to investigate the effects of gait training on ground level with partial body weight support (BWS)in individuals with stroke during overground walking with no BWS.

Studieoversigt

Detaljeret beskrivelse

Individuals were mechanically supported on a BWS system as they walked on ground level. All individuals started the training with 30% of body weight unloading and after three weeks, this percentage was reduced to 20% for the remainder of the six-week training period. The criterion used to reduce the percentage of BWS was the individual's ability to maintain alignment of the trunk and to transfer the weight to and from the paretic limb during gait. Individuals' body mass was measured weekly to ensure the appropriate percentage of body weight unloading.

During the training sessions, a physical therapist encouraged the individuals to walk as fast as possible, and feedback was provided in order to improve gait performance, such as vertical alignment of the trunk, symmetric limb weight distribution, and proper movement of the lower limbs. Heart rate and blood pressure were observed at beginning and end of each session, and when the patients reported any symptoms of discomfort during the session. Rest periods were allowed during the training sessions according to individual need.

All individuals were submitted to gait training sessions of 45 minutes, three times a week, on alternating day during six weeks, completing a total of 18 sessions. None of them were given any other type of physical intervention or conventional gait training, stretching, muscle strengthening or endurance exercise while participating in this study.

In order to verify the effects of the described gait training, individuals were assessed before and after gait training program, walking freely at self-selected comfortable speed along a 10 m walkway six times. They were videotaped by four digital cameras (AG-DVC7P, Panasonic) at 60 Hz, which were positioned bilaterally in order to allow simultaneous kinematics measurement of paretic and nonparetic limbs in either direction of motion (from left to right and vice-versa). During the evaluation, individuals were not allowed to use any assistive device, and they walked with the physical therapists' assistance to keep balance, when necessary.

Passive reflective markers were placed on the nonparetic and paretic sides of the body at the following anatomical locations: head of the fifth metatarsal, lateral malleolus, lateral epicondyle of the femur, greater trochanter, and acromion, in order to define the foot, shank, thigh, and trunk segments, respectively. The digitalization and the reconstruction of all markers were performed using Ariel Performance Analysis System - APAS (Ariel Dynamics, Inc.) software, and filtering and posterior analyses were performed using Matlab software (MathWorks, Inc. - Version 6.5). Reconstruction of the real coordinates was performed using the direct linear transformation (DLT) procedure.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Ikke anvendelig

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Elapsed time since stroke longer than one year
  • Ability to walk approximately 10 m with or without assistance
  • Spasticity classified as below level 3 by the Modified Ashworth Scale

Exclusion Criteria:

  • Presence of clinical signs of heart failure (New York Heart Association), arrhythmia, or angina pectoris
  • Absence of spasticity
  • Presence of orthopedic or other neurological diseases that compromised gait
  • Presence of severe cognitive or communication impairments

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean walking speed
Tidsramme: Six weeks
Mean walking speed was evaluated before and after the training period of six weeks
Six weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Step length and step symmetry
Tidsramme: Six weeks
Step length and step symmetry were evaluated before and after the training period of six weeks
Six weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Ana MF Barela, Doctor, Cruzeiro do Sul University

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. august 2007

Primær færdiggørelse (Faktiske)

1. december 2007

Studieafslutning (Faktiske)

1. april 2008

Datoer for studieregistrering

Først indsendt

25. marts 2010

Først indsendt, der opfyldte QC-kriterier

26. marts 2010

Først opslået (Skøn)

29. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

29. marts 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. marts 2010

Sidst verificeret

1. juli 2006

Mere information

Begreber relateret til denne undersøgelse

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 .

Kliniske forsøg med Vaskulær ulykke, hjerne

Kliniske forsøg med Body weight support system on ground level

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