Effects of Treadmill Gait Training With Loading in Individuals With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113098
• Other study ID #: 488.293
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2015

Study information

• Verified date: May 2019
• Source: Universidade Federal do Rio Grande do Norte
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Stroke

Intervention

Other:
• Treadmill, ankle load
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
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

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Norte	Natal	Rio Grande Do Norte

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Rio Grande do Norte

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ground reaction force, in Newtons	Vertical component of ground reaction force, measured using a force platform	Until one year after stroke
Primary	Angular displacements of hip, knee and ankle (in degrees)	Angular gait variables, measured by a system of movement analysis.	Until one year after stroke
Primary	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	speed (meters/second)	Spatiotemporal gait variable, measured by a system of movement analysis	Until one year after stroke
Secondary	double support time (in seconds)	Spatiotemporal gait variable, measured by a system of movement analysis	Until one year after stroke
Secondary	step length (in meters)	Spatiotemporal gait variable, measured by a system of movement analysis	Until one year after stroke
Secondary	stride length (in meters)	Spatiotemporal gait variable, measured by a system of movement analysis	Until one year after stroke