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Body Weight Support Training on Ground Level (BWSGR)

Primary Purpose

Cerebrovascular Accident, Cerebrovascular Stroke, Vascular Accident, Brain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Body weight support system on ground level
Sponsored by
Universidade Federal de Sao Carlos
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebrovascular Accident focused on measuring gait, ambulation, kinematics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Mean walking speed
    Mean walking speed was evaluated before and after the training period of six weeks

    Secondary Outcome Measures

    Step length and step symmetry
    Step length and step symmetry were evaluated before and after the training period of six weeks

    Full Information

    First Posted
    March 25, 2010
    Last Updated
    March 26, 2010
    Sponsor
    Universidade Federal de Sao Carlos
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01094470
    Brief Title
    Body Weight Support Training on Ground Level
    Acronym
    BWSGR
    Official Title
    Ground-level Partial Body Weight Support Gait Training for Individuals With Chronic Stroke
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2007 (undefined)
    Primary Completion Date
    December 2007 (Actual)
    Study Completion Date
    April 2008 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Universidade Federal de Sao Carlos
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebrovascular Accident, Cerebrovascular Stroke, Vascular Accident, Brain
    Keywords
    gait, ambulation, kinematics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    12 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    Body weight support system on ground level
    Other Intervention Name(s)
    partial body weight support, body weight unloading, body weight alleviation
    Intervention Description
    Gait training with body weight support on ground level with sessions of 45 minutes, three times a week, on alternating day during six weeks, completing a total of 18 sessions.
    Primary Outcome Measure Information:
    Title
    Mean walking speed
    Description
    Mean walking speed was evaluated before and after the training period of six weeks
    Time Frame
    Six weeks
    Secondary Outcome Measure Information:
    Title
    Step length and step symmetry
    Description
    Step length and step symmetry were evaluated before and after the training period of six weeks
    Time Frame
    Six weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ana MF Barela, Doctor
    Organizational Affiliation
    Cruzeiro do Sul University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19951435
    Citation
    Sousa CO, Barela JA, Prado-Medeiros CL, Salvini TF, Barela AM. The use of body weight support on ground level: an alternative strategy for gait training of individuals with stroke. J Neuroeng Rehabil. 2009 Dec 1;6:43. doi: 10.1186/1743-0003-6-43.
    Results Reference
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    Body Weight Support Training on Ground Level

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