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Postural Responses to External Perturbation in Post-Stroke

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ClinicalTrials.gov Identifier: NCT01912794
Recruitment Status : Unknown
Verified July 2013 by Alessandra Rezende Martinelli, University of Sao Paulo.
Recruitment status was:  Not yet recruiting
First Posted : July 31, 2013
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
Alessandra Rezende Martinelli, University of Sao Paulo

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.

Condition or disease Intervention/treatment
Stroke Other: Sensory Intervention

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation
Study Start Date : August 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sensory Conditions Other: Sensory Intervention
  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.



Primary Outcome Measures :
  1. Displacement amplitude of the CP to the anterior-posterior and medial-lateral [ Time Frame: 2 months ]
    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.


Secondary Outcome Measures :
  1. Coordination between the hip and ankle joint [ Time Frame: 2 months ]
    Coordination between the hip and ankle joints, which is evaluated by adjusting the angle displacement data, hip and ankle angle within 95% of an ellipse surrounding the values of the disturbance moment until the end of the trial. Will be carried out a regression analysis to identify the slope of the fitted ellipse. Slopes greater indicate a greater share of the ankle in relation to the hip


Other Outcome Measures:
  1. Muscle activation latency [ Time Frame: 2 months ]
    This outcome measure is time between the time of release and the first load value 3 standard deviations above the mean magnitude in the 200 ms prior to postural disturbance, with subsequent values increasing.



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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria are as follows. Healthy participants: absence of detectable neurological or physical malfunction which might affect postural control, no use of drugs affecting body balance and preserved mental capacity. Stroke patients: capacity to sustain independently orthostatic posture for at least 5 min. and preserved mental capacity.

Exclusion Criteria:

  • Exclusion Criteria are: no orthopedic malfunction, no clinical instability associated with systemic disease, no use of drugs affecting body balance and presence of "pusher syndrome".

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912794


Contacts
Contact: Alessandra R Martinelli, Master +551681490337 lerezendemartinelli@yahoo.com.br

Locations
Brazil
Escola de Educação física e Esporte, Universidade de São Paulo Not yet recruiting
São Paulo, Brazil, 05508-030
Contact: Alessandra R Martinelli, Master    +55113091-8795    lerezendemartinelli@yahoo.com.br   
Principal Investigator: Alessandra R Martinelli, Master         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Luis A Teixeira, PhD

Responsible Party: Alessandra Rezende Martinelli, PhD student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01912794     History of Changes
Other Study ID Numbers: SMH-2011/18173-3
First Posted: July 31, 2013    Key Record Dates
Last Update Posted: August 1, 2013
Last Verified: July 2013

Keywords provided by Alessandra Rezende Martinelli, University of Sao Paulo:
Cerebrovascular Accident
Rehabilitation
Sensory System

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases