Effects of Ground Level Gait Training With Body Weight Support (BWS) and Functional Electrical Stimulation (FES)

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Universidade Federal de Sao Carlos
ClinicalTrials.gov Identifier:
NCT01106755
First received: April 19, 2010
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Hemiparesis
Stroke
Device: gait training on ground level using BWS
Device: gait training on ground level using BWS associated to FES

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ground-level Gait Training Combining Body Weight Support and Functional Electrical Stimulation in People Following Chronic Stroke

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

Primary Outcome Measures:
  • kinematic evaluation [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 12
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hemiparetic gait
gait training on ground level
Device: gait training on ground level using BWS
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.
Device: gait training on ground level using BWS associated to FES
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01106755

Locations
Brazil
Universidade Federal de Sao Carlos
Sao Carlos, Sao Paulo, Brazil
Sponsors and Collaborators
Universidade Federal de Sao Carlos
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Tania F Salvini, PhD Universidade Federal de Sao Carlos (Sao Paulo - Brazil)
  More Information

No publications provided by Universidade Federal de Sao Carlos

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tania de Fatima Salvini, Universidade Federal de São Carlos
ClinicalTrials.gov Identifier: NCT01106755     History of Changes
Other Study ID Numbers: UFSCar-240781
Study First Received: April 19, 2010
Last Updated: April 19, 2010
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Federal de Sao Carlos:
kinematic
hemiparesis
gait
Body weight support
Functional electrical stimulation

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

ClinicalTrials.gov processed this record on September 29, 2014