NCT02088255

Brief Summary

The purpose of this study is evaluate the effects of walking training with partial body weight support on static (floor) and dynamic (treadmill) surfaces in individuals with hemiparesis due to stroke. For this purpose, two training protocols will be employed in three experimental groups: G1 will do the walking training with partial body weight support on static surfaces and G2 will do the walking training with partial body weight support on dynamic surfaces

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Mar 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

March 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

March 8, 2016

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

March 10, 2014

Last Update Submit

March 7, 2016

Conditions

Stroke

Keywords

RehabilitationGaitStrokeBiomechanics

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in the gait velocity

    Speed at which subjects walked measured by the 10 meters test

    Baseline, immediately after and six weeks after training cessation.

Secondary Outcomes (4)

  • Distribution of body weight

    Baseline, immediately after and six weeks after training cessation.

  • Functional independence

    Baseline, immediately after and six weeks after training cessation.

  • Lower limb recovery

    Baseline, immediately after and six weeks after training cessation.

  • Endurance

    Baseline, immediately after and six weeks after training cessation.

Other Outcomes (3)

  • Spacial and temporal variables

    Baseline, immediately after and six weeks after training cessation.

  • Center of Pressure

    Baseline, immediately after and six weeks after training cessation.

  • articular and segment angles

    Baseline, immediately after and six weeks after training cessation.

Study Arms (2)

Static surface

ACTIVE COMPARATOR

The subjects will do the walking training with partial body weight support on static surface. The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions

Procedure: Static surface

dynamic surface

ACTIVE COMPARATOR

The subjects will do the walking training with partial body weight support on dynamic surface. The will be submitted to three weekly training sessions of approximately 45 minutes each , for six weeks , totaling 18 sessions

Procedure: Dynamic surface

Interventions

Static surfacePROCEDURE

During all session time the subject will walk on the floor with partial body weight support. This protocol will be repeated in all sessions.

Also known as: floor walking training
Static surface
Dynamic surfacePROCEDURE

During all session time the subject will walk on the treadmill with partial body weight support. This protocol will be repeated in all sessions.

Also known as: Treadmill Training
dynamic surface

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One-sided hemiparesis, No heart disease (or medical clearance to participate in the study), No orthopedic impairments and / or neurological symptoms that may alter the the gait, no history of thrombophlebitis or deep vein thrombosis, Ability to understand and follow verbal commands, Can walk alone or with canes of approximately 10 m; Spasticity degree mild to moderate in the affected lower limb with levels of classification between 0 and 2 in the Ashworth spasticity scale modified

You may not qualify if:

  • Heart frequency increase more than 75% of the maximum or have any other general instability during training that may lead risk for the health during the training,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cruzeiro do Sul University

São Paulo, São Paulo, Brazil

Location

Related Publications (1)

  • Gama GL, Celestino ML, Barela JA, Forrester L, Whitall J, Barela AM. Effects of Gait Training With Body Weight Support on a Treadmill Versus Overground in Individuals With Stroke. Arch Phys Med Rehabil. 2017 Apr;98(4):738-745. doi: 10.1016/j.apmr.2016.11.022. Epub 2016 Dec 27.

    PMID: 28034719DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 14, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 8, 2016

Record last verified: 2015-07

Locations

BR(1)