Stroke Nos Without Residual DeficitsNCT02082938
The Use of Brace to Retrain Hemiparetic Gait
A study testing Bracing in people with Stroke Nos Without Residual Deficits, run by Federal University of Health Science of Porto Alegre.
Trial summary
The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke Nos Without Residual Deficits
- What is being tested?
- Bracing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2012to Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.
Who cannot join
- conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language
About this study
Official title: The Use of a Brace to Retrain Hemiparetic Gait in Patients With Genu Recurvatum: Effects on Plantar Pressure Distribution
The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients.
Read the detailed description
Objective To compare the behavior of plantar pressure peak distribution, before and after training using a brace for gait rehabilitation.
Method The brace was developed with the aim of promoting better biomechanical alignment, as well as providing proprioceptive information in order to stimulate action in the knee's flexor muscle groups, thus facilitating the activation pattern contrary to what occurs during genu recurvatum. We conducted a quasi-experimental "before and after" study with twelve hemiparetic adult patients who had genu recurvatum in the gait. The plantar pressure peaks were compared at the various moments of the study.
- Conditions
- Stroke Nos Without Residual Deficits
- Being tested
- Bracing
- Keywords
- stroke,, rehabilitation,, hemiparesis,, gait training
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BracingDevice
Twice a week, for a period of 5 weeks, before the sessions in the physiotherapy clinic the patients participating in the study were asked to walk at a self-selected speed on flat ground along a corridor 50 meters long, with the brace being used for fifteen minutes of gait retraining of the affected side.
| Study group | Role | What they receive |
|---|---|---|
| Bracing | Experimental | Bracing: the patients began four weeks of training the gait with the brace, under the guidance and observation of the physiotherapist belonging to the group of authors of this study. Receives: Device: Bracing |
What is being measured
The primary outcome is the main question the study is designed to answer.
distribution of plantar pressures during walking
To evaluate the distribution of plantar pressures during walking, for individuals with hemiparesis, before and after training with a brace for gait retraining and control of genu recurvatum.
To observe the gait evolution of 12 patientes after the trainnig with a orthotic device.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2014 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Nos Without Residual DeficitsStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Éder Kröeff Cardoso, Federal University of Health Science of Porto Alegre
- Investigators
- Éder K Cardoso, Master, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02082938
- Sponsor's protocol ID
- Eder01
- Status last verified
- Mar 2012
- First submitted
- 4 Mar 2014
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Brace to Retrain Hemiparetic Gait in Patients With Genu Recurvatum: Effects on Plantar Pressure Distribution
- ClinicalTrials.gov ID
- NCT02082938
- Acronym / sponsor ID
- Eder01
- Conditions
- Stroke Nos Without Residual Deficits
- Keywords
- stroke,, rehabilitation,, hemiparesis,, gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Mar 2014 (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.
The purpose of this study is to verify if the incorporation of a new brace, which assists in gait rehabilitation, can contribute to the rehabilitation process for stroke patients.
Detailed description
Objective To compare the behavior of plantar pressure peak distribution, before and after training using a brace for gait rehabilitation.
Method The brace was developed with the aim of promoting better biomechanical alignment, as well as providing proprioceptive information in order to stimulate action in the knee's flexor muscle groups, thus facilitating the activation pattern contrary to what occurs during genu recurvatum. We conducted a quasi-experimental "before and after" study with twelve hemiparetic adult patients who had genu recurvatum in the gait. The plantar pressure peaks were compared at the various moments of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bracing | Experimental | Device: BracingBracing: the patients began four weeks of training the gait with the brace, under the guidance and observation of the physiotherapist belonging to the group of authors of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the presence of hemiparesis after the stroke, with an evolution time of between 6 and 24 months, the ability to walk without using assistive aids, and the presence of genu recurvatum during the mid-stance in the gait.
Key exclusion criteria (1 listed)
- conditions that would preclude evaluation and training with the brace; for example, the presence of contractures or fixed deformities in the lower limbs, and moderate to severe impairments related to cognition, perception, attention, or language
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 |
|---|---|---|
| BracingTwice a week, for a period of 5 weeks, before the sessions in the physiotherapy clinic the patients participating in the study were asked to walk at a self-selected speed on flat ground along a corridor 50 meters long, with the brace being used for fifteen minutes of gait retraining of the affected side. | Device | Bracing |
Primary outcome
distribution of plantar pressures during walking
Time frame: 4 weeks
To evaluate the distribution of plantar pressures during walking, for individuals with hemiparesis, before and after training with a brace for gait retraining and control of genu recurvatum. To observe the gait evolution of 12 patientes after the trainnig with a orthotic device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2014.
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.
Éder K Cardoso, Master principal investigator
Federal University of Health Science of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Bracing in people with Stroke Nos Without Residual Deficits, run by Federal University of Health Science of Porto Alegre.
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: finished, as of the sponsor's last update on 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
distribution of plantar pressures during walking (time frame: 4 weeks). 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 10 Mar 2014.