NCT01912794

Brief Summary

To maintain stable body balance in daily activities, the ability to respond to external perturbations is an essential factor. Such capacity is limited in pathological conditions, such as in stroke, in which postural control is impaired due to lesions to the central nervous system. Impairment to postural control increases body sway during upright posture and leads to augmented frequency of falls. In this sense, the identification of mechanisms involved in body balance disorders after stroke is particularly important in situations of postural perturbation. The purpose of this project is to evaluate reactive postural responses to unpredictable external perturbations, analyzing postural dysfunctions caused by lesion to different brain areas as a result of stroke, and test principles of dynamic body balance rehabilitation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

6 months

First QC Date

July 26, 2013

Last Update Submit

July 30, 2013

Conditions

Keywords

Cerebrovascular AccidentRehabilitationSensory System

Outcome Measures

Primary Outcomes (1)

  • Displacement amplitude of the CP to the anterior-posterior and medial-lateral

    This outcome measure quantified by the difference between the maximum values of the anterior-posterior and medial-lateral after the start of trial and average position in the axis anteroposterior and mediolateral, respectively, in the 200 ms prior to the onset of the trial.

    2 months

Secondary Outcomes (1)

  • Coordination between the hip and ankle joint

    2 months

Other Outcomes (1)

  • Muscle activation latency

    2 months

Study Arms (1)

Sensory Conditions

EXPERIMENTAL
Other: Sensory Intervention

Interventions

1. full sensory information, whose participants will practice balancing tasks without constraint sensory body; 2. sensory constraint, whose participants will practice the same balance tasks with constraint body of visual and tactile information from the soles of the feet; 3. control, whose participants will exercise activities involving cognitive and upper limbs.

Sensory Conditions

Eligibility Criteria

Age45 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola de Educação física e Esporte, Universidade de São Paulo

São Paulo, São Paulo, 05508-030, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Luis A Teixeira, PhD

    STUDY DIRECTOR

Central Study Contacts

Alessandra R Martinelli, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 31, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2014

Study Completion

October 1, 2014

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations