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

NCT01106755 | Completed DMC

• 1 other identifier: UFSCar-240781
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis; Stroke

Keywords

kinematic; hemiparesis; gait; Body weight support; Functional electrical stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  4 months

Study Arms (1)

hemiparetic gait

EXPERIMENTAL

gait training on ground level

Device: gait training on ground level using BWS; Device: gait training on ground level using BWS associated to FES

Interventions

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.

hemiparetic gait

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.

hemiparetic gait

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Heart failure, angina pectoris, arrhythmias and other cardiovascular diseases
• Severe lung disease
• Orthopedic disorders
• Cognitive deficits

Sponsors & Collaborators

• Universidade Federal de Sao Carlos: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Federal de Sao Carlos

São Carlos, São Paulo, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22031271 DERIVED

MeSH Terms

Conditions

Paresis; Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Tania F Salvini, PhD

  Universidade Federal de Sao Carlos (Sao Paulo - Brazil)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 20, 2010
• Study Start: September 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: April 20, 2010

Record last verified: 2008-08

Locations

BR (1)