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Body Weight Support Training on Ground Level (BWSGR)

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ClinicalTrials.gov Identifier: NCT01094470
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : March 29, 2010
Information provided by:

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.

Condition or disease Intervention/treatment
Cerebrovascular Accident Cerebrovascular Stroke Vascular Accident, Brain Device: Body weight support system on ground level

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ground-level Partial Body Weight Support Gait Training for Individuals With Chronic Stroke
Study Start Date : August 2007
Primary Completion Date : December 2007
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Device: Body weight support system on ground level
    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.
    Other Names:
    • partial body weight support
    • body weight unloading
    • body weight alleviation

Outcome Measures

Primary Outcome Measures :
  1. Mean walking speed [ Time Frame: Six weeks ]
    Mean walking speed was evaluated before and after the training period of six weeks

Secondary Outcome Measures :
  1. Step length and step symmetry [ Time Frame: Six weeks ]
    Step length and step symmetry were evaluated before and after the training period of six weeks

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094470

Sponsors and Collaborators
Universidade Federal de Sao Carlos
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Ana MF Barela, Doctor Cruzeiro do Sul University
More Information

Responsible Party: Ana Maria Forti Barela, Cruzeiro do Sul University
ClinicalTrials.gov Identifier: NCT01094470     History of Changes
Other Study ID Numbers: BWS-BARELA
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: July 2006

Keywords provided by Universidade Federal de Sao Carlos:

Additional relevant MeSH terms:
Body Weight
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms