Postural Responses to External Perturbation in Post-Stroke
Primary Purpose
Stroke
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Sensory Intervention
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring Cerebrovascular Accident, Rehabilitation, Sensory System
Eligibility 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".
Sites / Locations
- Escola de Educação física e Esporte, Universidade de São Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sensory Conditions
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Coordination between the hip and ankle joint
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01912794
Brief Title
Postural Responses to External Perturbation in Post-Stroke
Official Title
Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Cerebrovascular Accident, Rehabilitation, Sensory System
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sensory Conditions
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Sensory Intervention
Intervention Description
full sensory information, whose participants will practice balancing tasks without constraint sensory body;
sensory constraint, whose participants will practice the same balance tasks with constraint body of visual and tactile information from the soles of the feet;
control, whose participants will exercise activities involving cognitive and upper limbs.
Primary Outcome Measure Information:
Title
Displacement amplitude of the CP to the anterior-posterior and medial-lateral
Description
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.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Coordination between the hip and ankle joint
Description
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
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Muscle activation latency
Description
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.
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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".
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alessandra R Martinelli, Master
Phone
+551681490337
Email
lerezendemartinelli@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis A Teixeira, PhD
Official's Role
Study Director
Facility Information:
Facility Name
Escola de Educação física e Esporte, Universidade de São Paulo
City
São Paulo
ZIP/Postal Code
05508-030
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra R Martinelli, Master
Phone
+55113091-8795
Email
lerezendemartinelli@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Alessandra R Martinelli, Master
12. IPD Sharing Statement
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Postural Responses to External Perturbation in Post-Stroke
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