Effects of Treadmill Gait Training With Loading in Individuals With Stroke

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke

Conditions
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Stroke, Gait Disorders, Neurologic

Intervention / Treatment
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* Other: Treadmill, ankle load
* Other: Treadmill


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treadmill, ankle load<br>The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb | Other: Treadmill, ankle load<br>* The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks<br>|
| Active Comparator: Treadmill<br>The control group (active comparator) will perform gait training on a treadmill | Other: Treadmill<br>* The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speed (meters/second) | Spatiotemporal gait variable, measured by a system of movement analysis | Until one year after stroke | 
| double support time (in seconds) | Spatiotemporal gait variable, measured by a system of movement analysis | Until one year after stroke | 
| step length (in meters) | Spatiotemporal gait variable, measured by a system of movement analysis | Until one year after stroke | 
| stride length (in meters) | Spatiotemporal gait variable, measured by a system of movement analysis | Until one year after stroke | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Stroke, Gait