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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106755
• Other study ID #: UFSCar-240781
• Status: Completed
• Phase: N/A
• First received: April 19, 2010
• Last updated: April 19, 2010
• Start date: September 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Hemiparesis
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de Sao Carlos	Sao Carlos	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes