Effects of Treadmill Gait Training With Loading in Individuals With Stroke

Effects of Treadmill Gait Training With Adding Load on Lower Limb of 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.

Study Overview

• Status: Completed
• Conditions: Stroke; Gait Disorders, Neurologic
• Intervention / Treatment: Other: Treadmill, ankle load; Other: Treadmill

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande Do Norte
    • Natal, Rio Grande Do Norte, Brazil, 59072-970
      • Universidade Federal do Rio Grande do Norte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treadmill, ankle load; The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb	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
Active Comparator: Treadmill; The control group (active comparator) will perform gait training on a treadmill	Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidade Federal do Rio Grande do Norte
• Investigators: Principal Investigator: Tatiana S Ribeiro, MSc, Universidade Federal do Rio Grande do Norte

Publications and helpful links

General Publications

• E Silva EMGS, Ribeiro TS, da Silva TCC, Costa MFP, Cavalcanti FADC, Lindquist ARR. Effects of constraint-induced movement therapy for lower limbs on measurements of functional mobility and postural balance in subjects with stroke: a randomized controlled trial. Top Stroke Rehabil. 2017 Dec;24(8):555-561. doi: 10.1080/10749357.2017.1366011. Epub 2017 Aug 31.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 10, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): June 3, 2019
• Last Update Submitted That Met QC Criteria: May 30, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Stroke; Gait
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Stroke; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 488.293