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Effects of Treadmill Gait Training With Loading in Individuals With Stroke

Primary Purpose

Stroke, Gait Disorders, Neurologic

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Treadmill, ankle load
Treadmill
Sponsored by
Universidade Federal do Rio Grande do Norte
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Gait, Rehabilitation

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universidade Federal do Rio Grande do Norte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treadmill, ankle load

Treadmill

Arm Description

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

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

Outcomes

Primary Outcome Measures

Ground reaction force, in Newtons
Vertical component of ground reaction force, measured using a force platform
Angular displacements of hip, knee and ankle (in degrees)
Angular gait variables, measured by a system of movement analysis.
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
Spatiotemporal gait variable, measured by a system of movement analysis

Secondary Outcome Measures

speed (meters/second)
Spatiotemporal gait variable, measured by a system of movement analysis
double support time (in seconds)
Spatiotemporal gait variable, measured by a system of movement analysis
step length (in meters)
Spatiotemporal gait variable, measured by a system of movement analysis
stride length (in meters)
Spatiotemporal gait variable, measured by a system of movement analysis

Full Information

First Posted
April 10, 2014
Last Updated
May 30, 2019
Sponsor
Universidade Federal do Rio Grande do Norte
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1. Study Identification

Unique Protocol Identification Number
NCT02113098
Brief Title
Effects of Treadmill Gait Training With Loading in Individuals With Stroke
Official Title
Effects of Treadmill Gait Training With Adding Load on Lower Limb of Individuals With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio Grande do Norte

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Gait Disorders, Neurologic
Keywords
Stroke, Gait, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treadmill, ankle load
Arm Type
Experimental
Arm Description
The experimental group will perform gait training on a treadmill with added load to the non-paretic lower limb
Arm Title
Treadmill
Arm Type
Active Comparator
Arm Description
The control group (active comparator) will perform gait training on a treadmill
Intervention Type
Other
Intervention Name(s)
Treadmill, ankle load
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Treadmill
Intervention Description
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 Outcome Measure Information:
Title
Ground reaction force, in Newtons
Description
Vertical component of ground reaction force, measured using a force platform
Time Frame
Until one year after stroke
Title
Angular displacements of hip, knee and ankle (in degrees)
Description
Angular gait variables, measured by a system of movement analysis.
Time Frame
Until one year after stroke
Title
Symmetry ratio (swing time of paretic limb/swing time of non-paretic limb)
Description
Spatiotemporal gait variable, measured by a system of movement analysis
Time Frame
Until one year after stroke
Secondary Outcome Measure Information:
Title
speed (meters/second)
Description
Spatiotemporal gait variable, measured by a system of movement analysis
Time Frame
Until one year after stroke
Title
double support time (in seconds)
Description
Spatiotemporal gait variable, measured by a system of movement analysis
Time Frame
Until one year after stroke
Title
step length (in meters)
Description
Spatiotemporal gait variable, measured by a system of movement analysis
Time Frame
Until one year after stroke
Title
stride length (in meters)
Description
Spatiotemporal gait variable, measured by a system of movement analysis
Time Frame
Until one year after stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tatiana S Ribeiro, MSc
Organizational Affiliation
Universidade Federal do Rio Grande do Norte
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Norte
City
Natal
State/Province
Rio Grande Do Norte
ZIP/Postal Code
59072-970
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
28859603
Citation
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.
Results Reference
derived

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Effects of Treadmill Gait Training With Loading in Individuals With Stroke

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