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Completed

NCT Number: NCT02113098

Effects of Treadmill Gait Training With Loading in Individuals With Stroke

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.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Norte

Natal, Rio Grande do Norte, 59072-970, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Treadmill, ankle load

Other

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

treadmill

Other

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

Primary outcomes

  1. Ground reaction force, in Newtons

    Time frame: Until one year after stroke

    Vertical component of ground reaction force, measured using a force platform

  2. Angular displacements of hip, knee and ankle (in degrees)

    Time frame: Until one year after stroke

    Angular gait variables, measured by a system of movement analysis.

  3. Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)

    Time frame: Until one year after stroke

    Spatiotemporal gait variable, measured by a system of movement analysis

Secondary outcomes

  1. speed (meters/second)

    Time frame: Until one year after stroke

    Spatiotemporal gait variable, measured by a system of movement analysis

  2. double support time (in seconds)

    Time frame: Until one year after stroke

    Spatiotemporal gait variable, measured by a system of movement analysis

  3. step length (in meters)

    Time frame: Until one year after stroke

    Spatiotemporal gait variable, measured by a system of movement analysis

  4. stride length (in meters)

    Time frame: Until one year after stroke

    Spatiotemporal gait variable, measured by a system of movement analysis

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio Grande do Norte

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 14, 2014
Registry last updated
Jun 3, 2019

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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