StrokeNCT04077814
Association Between the tDCS and FDS for Gait Rehabilitation After Stroke
A study testing Foot Drop Stimulatio - Neuro Orthosis and Transcranial direct brain stimulation 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 tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate 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 Stimulatio - Neuro Orthosis and Transcranial direct brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Sep 2019to 30 Sep 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
- No current use of antiepileptic drugs for seizures
- 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: Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial
The aim of this study is to verify the effectiveness of tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.
- Conditions
- Stroke
- Being tested
- Foot Drop Stimulatio - Neuro Orthosis, Transcranial direct brain stimulation
- Keywords
- Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke
- 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 Stimulatio - Neuro OrthosisDevice
Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
Transcranial direct brain stimulationDevice
Transcranial direct brain stimulation on motor cortex
| Study group | Role | What they receive |
|---|---|---|
| ShamtDCS+FDS | Active comparator | Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS) Receives: Device: Foot Drop Stimulatio - Neuro Orthosis |
| tDCS+FDS | Experimental | Chronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS) Receives: Device: Foot Drop Stimulatio - Neuro Orthosis; Device: Transcranial direct brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic gait anaysis.
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Measured: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Secondary outcomes (9)
Kinetic gait anaysis.
Assessed by force platform (BTS P-6000)
Measured: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Postural Control
Evaluated by Center of Pressure (COP) displacement assessed on force platform (BTS P-6000)
Measured: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Functional Mobility
Evaluated by means of the Timed Up \& Go Test (TUG)
Measured: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)
The SSQOL questionnaire assesses the quality of life of stroke subject, and it contains 49 items with 12 domains (energy, family role, language, mobility, mood, personality, self-care, social role, reasoning, upper limb function, vision and work/productivity). There are three possible answers on the 5-point Likert scale.
The SSOOL questionnaire score reports a minimum of 49 points and a maximum of 245 points. The lower values represent the more dependence and difficulty to perform tasks.
Measured: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
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: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Serum levels of Brain-derived neurotrophic fator (BDNF).
The biomarker BDNF will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: The outcome will be assessed at baseline and 2 weeks after the intervention.
Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)
The biomarker IGFBP-3 will be analyzed in the blood sample to evaluate the neuromuscular adaptations indirectly. Serum IGFBP-3 levels will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: The outcome will be assessed at baseline and 2 weeks after the intervention.
Serum levels of insulin-like growth factors 1 (IGF-1)
The IGF-1 will be analyzed in the blood sample to evaluate the neuromuscular adaptations indirectly. Serum IGF-1 levels will be determined using the enzyme-linked immunosorbent assay (ELISA) method.
Measured: The outcome will be assessed at baseline and 2 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start20 Sep 2019
- Primary completion20 Sep 2019
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 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
- NCT04077814
- Sponsor's protocol ID
- tDCS_FDS_2018
- Status last verified
- Feb 2021
- First submitted
- 12 Jun 2019
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
da Cunha MJ, Pinto C, Schifino GP, Sant'Anna Py I, Cimolin V, Pagnussat AS. Bicephalic Transcranial Direct-Current Stimulation Does Not Add Benefits to a Footdrop Stimulator for Improving Functional Mobility in People With Chronic Hemiparesis After Stroke: A Double-Blind, Randomized Controlled Trial. Phys Ther. 2022 Aug 4;102(8):pzac079. doi: 10.1093/ptj/pzac079.
PubMed 35689805
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
- Association Between the Transcranial Direct Current Stimulation (tDCS) and Foot Drop Stimulation (FDS) for Gait Rehabilitation After Stroke - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04077814
- Acronym / sponsor ID
- tDCS_FDS_2018
- Conditions
- Stroke
- Keywords
- Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 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
- 30 Sep 2020 (actual)
- First posted
- 4 Sep 2019 (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 tDCS combined with foot drop stimulation (FDS) on gait rehabilitation of post-stroke subjects with mild and moderate compromise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ShamtDCS+FDS | Active comparator | Device: Foot Drop Stimulatio - Neuro OrthosisChronic stroke patients submitted to Foot Drop Stimulation (FDS) + Sham Transcranial direct brain stimulation (tDCS) |
| tDCS+FDS | Experimental | Device: Foot Drop Stimulatio - Neuro Orthosis, Device: Transcranial direct brain stimulationChronic stroke patients submitted to Foot Drop Stimulation (FDS) + Transcranial direct brain stimulation (tDCS) |
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 (3 listed)
- No current use of antiepileptic drugs for seizures
- 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 Stimulatio - Neuro OrthosisWalkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait. | Device | ShamtDCS+FDS, tDCS+FDS |
| Transcranial direct brain stimulationTranscranial direct brain stimulation on motor cortex | Device | tDCS+FDS |
Primary outcome
Kinematic gait anaysis.
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
9 secondary outcomes
Kinetic gait anaysis.
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Postural Control
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Functional Mobility
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Assessed by means of the Stroke-Specific Quality of Life Questionnaire (SSQOL)
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Muscular tone assessed by the Modified Ashworth Scale
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Assessment of Sensorimotor Recovery After Stroke by Fugl-Meyer scale
Time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.
Serum levels of Brain-derived neurotrophic fator (BDNF).
Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.
Serum levels of Insulin-like growth factor binding protein-3 (IGFBP-3)
Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.
Serum levels of insulin-like growth factors 1 (IGF-1)
Time frame: The outcome will be assessed at baseline and 2 weeks after the intervention.
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.
- Derived from this study: PubMed 35689805da Cunha MJ, Pinto C, Schifino GP, Sant'Anna Py I, Cimolin V, Pagnussat AS. Bicephalic Transcranial Direct-Current Stimulation Does Not Add Benefits to a Footdrop Stimulator for Improving Functional Mobility in People With Chronic Hemiparesis After Stroke: A Double-Blind, Randomized Controlled Trial. Phys Ther. 2022 Aug 4;102(8):pzac079. doi: 10.1093/ptj/pzac079.
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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 Stimulatio - Neuro Orthosis and Transcranial direct brain stimulation 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 3 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?
Kinematic gait anaysis. (time frame: The outcome will assess at baseline and two weeks after the intervention. One month later that finished the intensive treatment subjects will re-evaluate.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077814, which also lists 1 linked publication.
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.