Effects of Treadmill Gait Training With Loading in Individuals With Stroke

Not Applicable

Completed

• Conditions: Stroke; Gait Disorders, Neurologic
• Interventions: Other: Treadmill, ankle load; Other: Treadmill

• Registration Number: NCT02113098
• Lead Sponsor: Universidade Federal do Rio Grande do Norte

Brief Summary

The purpose of this study is to determine whether the add load on non-paretic lower limb of individuals that suffer a stroke, while walking on a treadmill, is effective for restore gait symmetry of these individuals, in a subacute phase of stroke.

Detailed Description

This is a randomized and blinded clinical trial, in which participants are being randomly divided into experimental group and control group, in order to verify the effects of adding load on gait symmetry after stroke. 40 individuals will participate, and the calculation of sample size was performed from the ratio variable symmetry of swing time, based on previous study. Whereas about 15% of individuals could give up to participate in the study during their course (dropout rate), we determined a number of 20 participants in each group.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-10
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Primary Completion: 2015-06
• Study Completion: 2015-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-30
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• First episode of stroke (ischemic or hemorrhagic) which determined unilateral hemiparesis
• Time of lesion less one year
• Able to walk independently by 10 feet on flat surface without the use of assistive devices
• Gait speed less than 0.8 m / s
• Ability to understand and obey simple commands

Exclusion Criteria

• Instability of cardiac conditions
• Adverse clinical conditions affecting balance and / or gait
• Pain and / or severe discomfort that impede the realization of the proposed activities
• Decompensation in systemic blood pressure, with the systolic and diastolic values above 200 mmHg and 110 mmHg, respectively, before and / or after training
• Submaximal heart rate above the allowed values during training

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treadmill, ankle load	Treadmill, ankle load	The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb
Treadmill	Treadmill	The control group (active comparator) will perform gait training on a treadmill

Primary Outcome Measures

Name	Time	Method
Ground reaction force, in Newtons	Until one year after stroke	Vertical component of ground reaction force, measured using a force platform
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)	Until one year after stroke	Spatiotemporal gait variable, measured by a system of movement analysis
Angular displacements of hip, knee and ankle (in degrees)	Until one year after stroke	Angular gait variables, measured by a system of movement analysis.

Secondary Outcome Measures

Name	Time	Method
stride length (in meters)	Until one year after stroke	Spatiotemporal gait variable, measured by a system of movement analysis
speed (meters/second)	Until one year after stroke	Spatiotemporal gait variable, measured by a system of movement analysis
double support time (in seconds)	Until one year after stroke	Spatiotemporal gait variable, measured by a system of movement analysis
step length (in meters)	Until one year after stroke	Spatiotemporal gait variable, measured by a system of movement analysis

Trial Locations

Locations (1)

Universidade Federal do Rio Grande do Norte; 🇧🇷 Natal, Rio Grande Do Norte, Brazil