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

NCT ID: NCT01106755

Last Updated: 2010-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Hemiparesis Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hemiparetic gait

gait training on ground level

Group Type EXPERIMENTAL

gait training on ground level using BWS

Intervention Type DEVICE

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.

gait training on ground level using BWS associated to FES

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

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Universidade Federal de São Carlos

Principal Investigators

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Tania F Salvini, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos (Sao Paulo - Brazil)

Locations

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Universidade Federal de Sao Carlos

São Carlos, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22031271 (View on PubMed)

Other Identifiers

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UFSCar-240781

Identifier Type: -

Identifier Source: org_study_id

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