StrokeNCT01912794
Postural Responses to External Perturbation in Post-Stroke
A study testing Sensory Intervention in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Sensory Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2013to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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".
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Educação física e Esporte, Universidade de São Paulo
São Paulo, São Paulo, 05508-030
Alessandra R Martinelli, Master, +55113091-8795, lerezendemartinelli@yahoo.com.br
Alessandra R Martinelli, Master
About this study
Official title: Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation
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.
- Conditions
- Stroke
- Being tested
- Sensory Intervention
- Keywords
- Cerebrovascular Accident, Rehabilitation, Sensory System
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory InterventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Sensory Conditions | Experimental | Not described Receives: Other: Sensory Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Secondary outcomes (1)
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandra Rezende Martinelli, University of Sao Paulo
- Investigators
- Luis A Teixeira, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912794
- Sponsor's protocol ID
- SMH-2011/18173-3
- Status last verified
- Jul 2013
- First submitted
- 26 Jul 2013
- Last updated
- 1 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postural Responses to External Perturbation in Post-Stroke: Sensorimotor Integration and Rehabilitation
- ClinicalTrials.gov ID
- NCT01912794
- Acronym / sponsor ID
- SMH-2011/18173-3
- Conditions
- Stroke
- Keywords
- Cerebrovascular Accident, Rehabilitation, Sensory System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sensory Conditions | Experimental | Other: Sensory Intervention |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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".
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory Intervention1. 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. | Other | Sensory Conditions |
Primary outcome
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.
1 secondary outcome
Coordination between the hip and ankle joint
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis A Teixeira, PhD study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Intervention in people with Stroke, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alessandra R Martinelli, Master (+551681490337, lerezendemartinelli@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Displacement amplitude of the CP to the anterior-posterior and medial-lateral (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2013; AzTrials last refreshed its copy on 27 Oct 2026.