Postural Responses to External Perturbation in Post-Stroke

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Alessandra Rezende Martinelli, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01912794
First received: July 26, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

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 Intervention
Stroke
Other: Sensory Intervention

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Displacement amplitude of the CP to the anterior-posterior and medial-lateral [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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:
  • Coordination between the hip and ankle joint [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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:
  • Muscle activation latency [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 24
Study Start Date: August 2013
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Both
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".
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 26, 2013
Last Updated: July 30, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Cerebrovascular Accident
Rehabilitation
Sensory System

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

ClinicalTrials.gov processed this record on July 23, 2014