Back to resultsEffects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)
Primary Purpose
Hemiparesis, Stroke
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
gait training on ground level using BWS
gait training on ground level using BWS associated to FES
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring kinematic, hemiparesis, gait, Body weight support, Functional electrical stimulation
Eligibility Criteria
Inclusion Criteria:
- Elapsed time since stroke longer than 6 months
- Spasticity classified under level 3 according to the Modified Ashworth Scale
- The ability to walk classified at levels 2, 3 or 4 according to the Functional Ambulation Category
Exclusion Criteria:
- Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
- Severe lung disease
- Orthopedic disorders
- Cognitive deficits
Sites / Locations
- Universidade Federal de Sao Carlos
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hemiparetic gait
Arm Description
gait training on ground level
Outcomes
Primary Outcome Measures
kinematic evaluation
Participants were assessed walking freely at a comfortable self-selected speed before and after each training phase. The analyzed variables were: mean walking speed of locomotion; step length; stride length, speed and duration; initial and final double support duration; single-limb support duration; swing period; range of motion (ROM), maximum and minimum angles of foot, leg, thigh, and trunk segments of both paretic and nonparetic limbs.
Secondary Outcome Measures
Full Information
NCT ID
NCT01106755
First Posted
April 19, 2010
Last Updated
April 19, 2010
Sponsor
Universidade Federal de Sao Carlos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT01106755
Brief Title
Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)
Official Title
Ground-level Gait Training Combining Body Weight Support and Functional Electrical Stimulation in People Following Chronic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Universidade Federal de Sao Carlos
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to investigate the effects of gait training on ground level, combining BWS and FES in people following chronic stroke.
Detailed Description
The body weight support system (BWS) associated to a treadmill as well as to a functional electrical stimulation (FES) of the common peroneal nerve, has been proposed as a strategy for gait training in people following stroke. Moreover, it has also considered that the ground level is the most common locomotion surface, and that there is little information about the effects of gait training, on this kind of surface, in people with hemiparesis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis, Stroke
Keywords
kinematic, hemiparesis, gait, Body weight support, Functional electrical stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hemiparetic gait
Arm Type
Experimental
Arm Description
gait training on ground level
Intervention Type
Device
Intervention Name(s)
gait training on ground level using BWS
Intervention Description
An A1-B-A2 system was applied in which A1 and A2 corresponded to gait training on ground level using Body Weight Support (BWS). Each training phase was performed during 45 minutes, three times a week, for six weeks.
Intervention Type
Device
Intervention Name(s)
gait training on ground level using BWS associated to FES
Intervention Description
An A1-B-A2 system was applied in which B corresponded to the training associated to Functional Electrical Stimulation. Each training phase was performed during 45 minutes, three times a week, for six weeks.
Primary Outcome Measure Information:
Title
kinematic evaluation
Description
Participants were assessed walking freely at a comfortable self-selected speed before and after each training phase. The analyzed variables were: mean walking speed of locomotion; step length; stride length, speed and duration; initial and final double support duration; single-limb support duration; swing period; range of motion (ROM), maximum and minimum angles of foot, leg, thigh, and trunk segments of both paretic and nonparetic limbs.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elapsed time since stroke longer than 6 months
Spasticity classified under level 3 according to the Modified Ashworth Scale
The ability to walk classified at levels 2, 3 or 4 according to the Functional Ambulation Category
Exclusion Criteria:
Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
Severe lung disease
Orthopedic disorders
Cognitive deficits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tania F Salvini, PhD
Organizational Affiliation
Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Sao Carlos
City
Sao Carlos
State/Province
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22031271
Citation
Prado-Medeiros CL, Sousa CO, Souza AS, Soares MR, Barela AM, Salvini TF. Effects of the addition of functional electrical stimulation to ground level gait training with body weight support after chronic stroke. Rev Bras Fisioter. 2011 Nov-Dec;15(6):436-44. doi: 10.1590/s1413-35552011005000030. Epub 2011 Oct 27.
Results Reference
derived
Learn more about this trial
Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)
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