Body Weight Support Training on Ground Level (BWSGR)

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01094470
First received: March 25, 2010
Last updated: March 26, 2010
Last verified: July 2006
  Purpose

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 Intervention
Cerebrovascular Accident
Cerebrovascular Stroke
Vascular Accident, Brain
Device: Body weight support system on ground level

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ground-level Partial Body Weight Support Gait Training for Individuals With Chronic Stroke

Resource links provided by NLM:


Further study details as provided by Universidade Federal de Sao Carlos:

Primary Outcome Measures:
  • Mean walking speed [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Mean walking speed was evaluated before and after the training period of six weeks


Secondary Outcome Measures:
  • Step length and step symmetry [ Time Frame: Six weeks ] [ Designated as safety issue: No ]
    Step length and step symmetry were evaluated before and after the training period of six weeks


Enrollment: 12
Study Start Date: August 2007
Study Completion Date: April 2008
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Ana MF Barela, Doctor Cruzeiro do Sul University
  More Information

Publications:
Responsible Party: Ana Maria Forti Barela, Cruzeiro do Sul University
ClinicalTrials.gov Identifier: NCT01094470     History of Changes
Other Study ID Numbers: BWS-BARELA
Study First Received: March 25, 2010
Last Updated: March 26, 2010
Health Authority: Brazil: Institutional Review Board

Keywords provided by Universidade Federal de Sao Carlos:
gait
ambulation
kinematics

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

ClinicalTrials.gov processed this record on August 28, 2014