Postural Responses to External Perturbation in Post-Stroke

Stroke Clinical Trial

Official title:

Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01912794
• Other study ID #: SMH-2011/18173-3
• Status: Unknown status
• Phase: N/A
• First received: July 26, 2013
• Last updated: July 30, 2013
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: July 2013
• Source: University of Sao Paulo
• Contact: Alessandra R Martinelli, Master
• Phone: +551681490337
• Email: lerezendemartinelli[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 24
• Est. completion date: October 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 70 Years

Eligibility

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".

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• Sensory Intervention
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.

Locations

Country	Name	City	State
Brazil	Escola de Educação física e Esporte, Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle activation latency	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.	2 months
Primary	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	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	2 months