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
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring gait, ambulation, kinematics
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
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
NCT ID
NCT01094470
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
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
background
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Body Weight Support Training on Ground Level
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