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Completed

NCT Number: NCT01106755

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

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.

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Key information

Conditions

Hemiparesis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Sao Carlos

São Carlos, São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gait training on ground level using BWS

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

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.

Primary outcomes

  1. kinematic evaluation

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Universidade Federal de Sao Carlos

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Ground-level Gait Training Combining Body Weight Support and Functional Electrical Stimulation in People Following Chronic Stroke

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2010
Registry last updated
Apr 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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