Body Weight Support Training on Ground Level (BWSGR)

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.

Study Overview

• Status: Completed
• Conditions: Vascular Accident, Brain; Cerebrovascular Accident; Cerebrovascular Stroke
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean walking speed	Mean walking speed was evaluated before and after the training period of six weeks	Six weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step length and step symmetry	Step length and step symmetry were evaluated before and after the training period of six weeks	Six weeks

Collaborators and Investigators

• Sponsor: Universidade Federal de Sao Carlos
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Ana MF Barela, Doctor, Cruzeiro do Sul University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: March 25, 2010
• First Submitted That Met QC Criteria: March 26, 2010
• First Posted (Estimate): March 29, 2010

Study Record Updates

• Last Update Posted (Estimate): March 29, 2010
• Last Update Submitted That Met QC Criteria: March 26, 2010
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Keywords: gait; ambulation; kinematics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Body Weight
• Other Study ID Numbers: BWS-BARELA