Effects of Treadmill Gait Training With Loading in Individuals With Stroke

Universidade Federal do Rio Grande do Norte

Status: Completed

Conditions: Stroke; Gait Disorders, Neurologic

Treatments: Other: Treadmill; Other: Treadmill, ankle load

Study type: Interventional

Funder types: Other

Identifiers

NCT02113098

488.293

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Treadmill, ankle load

Experimental group

Description:

The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb

Treatment:

Other: Treadmill, ankle load

Treadmill

Active Comparator group

Description:

The control group (active comparator) will perform gait training on a treadmill

Treatment:

Other: Treadmill