NCT02113098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

June 3, 2019

Status Verified

May 1, 2019

Enrollment Period

1.2 years

First QC Date

April 10, 2014

Last Update Submit

May 30, 2019

Conditions

StrokeGait Disorders, Neurologic

Keywords

StrokeGaitRehabilitation

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • speed (meters/second)

    Until one year after stroke

  • double support time (in seconds)

    Until one year after stroke

  • step length (in meters)

    Until one year after stroke

  • stride length (in meters)

    Until one year after stroke

Study Arms (2)

Treadmill, ankle load

EXPERIMENTAL

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

Other: Treadmill, ankle load

Treadmill

ACTIVE COMPARATOR

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

Other: Treadmill

Interventions

Treadmill, ankle loadOTHER

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, ankle load
TreadmillOTHER

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

Treadmill

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Norte

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

Location

Related Publications (1)

  • 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.

    PMID: 28859603DERIVED

MeSH Terms

Conditions

StrokeGait Disorders, Neurologic

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Tatiana S Ribeiro, MSc

    Universidade Federal do Rio Grande do Norte

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 14, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2015

Study Completion

October 1, 2015

Last Updated

June 3, 2019

Record last verified: 2019-05

Locations

BR(1)