StrokeNCT04266899
The Effect of Neuro-orthosis on Gait Performer in Post Stroke Subjects
A study testing Foot Drop Stimulator - Neuro Orthosis and Treadmill in people with Stroke, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Foot Drop Stimulator - Neuro Orthosis and Treadmill
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2019to 20 Mar 2020
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with ischemic or hemorrhagic stroke diagnosis.
- Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
- Minimal cognitive ability to understand commands
- Able to walk 10 meters unassisted or with minimal assistance
Who cannot join
- Secondary musculoskeletal disorder involving the lower limb
- Contraindication for electrical stimulation
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Sciences of Porto Alegre
Porto Alegre, Rio Grande do Sul
About this study
Official title: The Effect of Neuro-orthosis on Gait Performer in Chronic Post Stroke Subjects
The aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise.
Read the detailed description
The stroke subjects are going to perform the walking training with Foot drop stimulator on the treadmill. All the evaluations will be performed with a foot drop stimulator turned off and on. One month later, that finished the intensive treatment; the participants were also evaluated only without the stimulation of FDS.
- Conditions
- Stroke
- Being tested
- Foot Drop Stimulator - Neuro Orthosis, Treadmill
- Keywords
- Cerebrovascular Stroke, Cerebral Stroke, Cerebrovascular Accident, Neurorehabilitation, Gait Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot Drop Stimulator - Neuro OrthosisDevice
The WalkAide system is a self-contained functional electrical stimulation device with a built-in tilt sensor and attaches with a cuff to the leg below the knee. The device stimulates the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
TreadmillDevice
Gait training on a treadmill
| Study group | Role | What they receive |
|---|---|---|
| FDS+Treadmill gait training | Experimental | Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks. Receives: Device: Foot Drop Stimulator - Neuro Orthosis; Device: Treadmill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of gait speed
Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Secondary outcomes (11)
Assessment of angular kinematics of hip, knee and ankle
Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Changes in center of pressure displacement
Assessed by force platform (BTS P-6000)
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Postural Control
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Functional Mobility
Evaluated by means of the Timed Up \& Go Test (TUG)
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Muscular tone assessed by the Modified Ashworth Scale
Assessed by the Modified Ashworth Scale. This scale consists of 5 ordinal values ranging from 0 (no tonus increase) to 4 (stiffness).
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
Fugl-Meyer scale of lower limb impairment. The evaluation includes measurement of voluntary movement, velocity, coordination and reflex activity, through an ordinal scale applied to each item: 0- cannot be performed, 1- partially performed, and 2-performed completely. Participants were also classified according their LL motor impairment in severe (0 to19), moderate (20 to 28) or mild (> 29 points).
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Gait speed in external environment
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy) during 10 meters walking test.
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of duration of stance and swing phase of gait
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Stride length and Step length of gait
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of cadence by means number of steps by the minute.
Evaluated by means inertial sensor (G-Sensor®, BTS Bioengineering, Italy), during 10 meters walking test.
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Harmonic Ration of Gait
Evaluated by means single miniaturized inertial sensor (G-Sensor®, BTS Bioengineering, Italy). The device collects the values of linear accelerations along three orthogonal axes (antero-posterior (AP) corresponding to the walking direction, medio-lateral (ML), and supero-inferior (V)). The Harmonic Ration is the ratio between the sum of the amplitudes of even harmonics and the sum of the amplitudes of odd harmonics calculated via the discrete Fourier transform along the antero-posterior (AP) and cranio-caudal (CC) directions; the opposite ratio is calculated along the latero-lateral axis (LL).
Measured: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start20 Sep 2019
- Primary completion20 Sep 2019
- Study completion20 Mar 2020
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
- 32 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, Aline de Souza Pagnussat, Federal University of Health Science of Porto Alegre
- Investigators
- Aline S Pagnussat, PhD, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266899
- Sponsor's protocol ID
- FDS_Stroke
- Status last verified
- Feb 2021
- First submitted
- 28 Jan 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Neuro-orthosis on Gait Performer in Chronic Post Stroke Subjects
- ClinicalTrials.gov ID
- NCT04266899
- Acronym / sponsor ID
- FDS_Stroke
- Conditions
- Stroke
- Keywords
- Cerebrovascular Stroke, Cerebral Stroke, Cerebrovascular Accident, Neurorehabilitation, Gait Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 20 Sep 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 12 Feb 2020 (actual)
- 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 aim of this study is to verify the effectiveness of foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild, moderate and severe compromise.
Detailed description
The stroke subjects are going to perform the walking training with Foot drop stimulator on the treadmill. All the evaluations will be performed with a foot drop stimulator turned off and on. One month later, that finished the intensive treatment; the participants were also evaluated only without the stimulation of FDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FDS+Treadmill gait training | Experimental | Device: Foot Drop Stimulator - Neuro Orthosis, Device: TreadmillChronic stroke patients submitted to Foot Drop Stimulation (FDS) + Treadmill gait training during two weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with ischemic or hemorrhagic stroke diagnosis.
- Mild, moderate or severe hemiparesis (chronic stroke - at least 6 months)
- Minimal cognitive ability to understand commands
- Able to walk 10 meters unassisted or with minimal assistance
Key exclusion criteria (2 listed)
- Secondary musculoskeletal disorder involving the lower limb
- Contraindication for electrical stimulation
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 |
|---|---|---|
| Foot Drop Stimulator - Neuro OrthosisThe WalkAide system is a self-contained functional electrical stimulation device with a built-in tilt sensor and attaches with a cuff to the leg below the knee. The device stimulates the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait. | Device | FDS+Treadmill gait training |
| TreadmillGait training on a treadmill | Device | FDS+Treadmill gait training |
Primary outcome
Assessment of gait speed
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Evaluated by means of the 3-D motion analysis system (capture system BTS SMART DX 400)
11 secondary outcomes
Assessment of angular kinematics of hip, knee and ankle
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Changes in center of pressure displacement
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Postural Control
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Functional Mobility
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Muscular tone assessed by the Modified Ashworth Scale
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Gait speed in external environment
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of duration of stance and swing phase of gait
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Stride length and Step length of gait
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of cadence by means number of steps by the minute.
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
Assessment of Harmonic Ration of Gait
Time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)
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 11 Feb 2021.
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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.
Aline S Pagnussat, PhD principal investigator
Federal University of Health Sciences of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Foot Drop Stimulator - Neuro Orthosis and Treadmill in people with Stroke, run by Federal University of Health Science of Porto Alegre 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 4 inclusion and 2 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 11 Feb 2021. 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?
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?
Assessment of gait speed (time frame: Change from Pre to Post treatment (2 weeks) and Post 3 (1 month follow-up)). 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 11 Feb 2021.