StrokeNCT02818608
Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke
A study testing Functional Electrical Stimulation (FES) and Combination of Transcranial direct brain stimulation (tDCS) and FES 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 FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Functional Electrical Stimulation (FES) and Combination of Transcranial direct brain stimulation (tDCS) and FES
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Aug 2017to 15 Jan 2019
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
- Ability to reach 60 degrees in the shoulder flexion
- Minimal cognitive ability to understand commands
- No current use of antiepileptic drugs for seizures
Who cannot join
- Painful shoulder, adhesive capsulitis or glenohumeral subluxation
- Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire
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 Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial
The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.
- Conditions
- Stroke
- Being tested
- Functional Electrical Stimulation (FES), Combination of Transcranial direct brain stimulation (tDCS) and FES
- 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.
Functional Electrical Stimulation (FES)Device
Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
Combination of Transcranial direct brain stimulation (tDCS) and FESDevice
Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
| Study group | Role | What they receive |
|---|---|---|
| Functional electrical stimulation (FES) | Active comparator | Chronic stroke patients submitted to functional electrical stimulation (FES). Receives: Device: Functional Electrical Stimulation (FES) |
| Combination of transcranial direct current stimulation and FES | Experimental | Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES). Receives: Device: Combination of Transcranial direct brain stimulation (tDCS) and FES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
3-D motion analysis system
Measured: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary outcomes (5)
Grip force assessed by means of dynamometer
Evaluated by means of dynamometer (Jamar)
Measured: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Manual dexterity assessed by means of the block and box test
Block and box test
Measured: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)
Questionnaire
Measured: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Muscular tone assessed by the Modified Ashworth Scale
Modified Ashworth Scale
Measured: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale
Fugl-Meyer scale
Measured: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start14 Aug 2017
- Primary completion13 Aug 2018
- Study completion15 Jan 2019
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
- 51 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818608
- Sponsor's protocol ID
- APAPS2018
- Status last verified
- Jun 2019
- First submitted
- 2 Nov 2015
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Salazar AP, Cimolin V, Schifino GP, Rech KD, Marchese RR, Pagnussat AS. Bi-cephalic transcranial direct current stimulation combined with functional electrical stimulation for upper-limb stroke rehabilitation: A double-blind randomized controlled trial. Ann Phys Rehabil Med. 2020 Jan;63(1):4-11. doi: 10.1016/j.rehab.2019.05.004. Epub 2019 May 31.
PubMed 31158553
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02818608
- Acronym / sponsor ID
- APAPS2018
- Conditions
- Stroke
- Keywords
- Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 30 Jun 2016 (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 aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe 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 |
|---|---|---|
| Functional electrical stimulation (FES) | Active comparator | Device: Functional Electrical Stimulation (FES)Chronic stroke patients submitted to functional electrical stimulation (FES). |
| Combination of transcranial direct current stimulation and FES | Experimental | Device: Combination of Transcranial direct brain stimulation (tDCS) and FESChronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES). |
Who may qualify
- Ages
- 30 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 and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
- Ability to reach 60 degrees in the shoulder flexion
- Minimal cognitive ability to understand commands
- No current use of antiepileptic drugs for seizures
Key exclusion criteria (2 listed)
- Painful shoulder, adhesive capsulitis or glenohumeral subluxation
- Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire
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 |
|---|---|---|
| Functional Electrical Stimulation (FES)Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS) | Device | Functional electrical stimulation (FES) |
| Combination of Transcranial direct brain stimulation (tDCS) and FESReal Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS) | Device | Combination of transcranial direct current stimulation and FES |
Primary outcome
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
3-D motion analysis system
5 secondary outcomes
Grip force assessed by means of dynamometer
Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Manual dexterity assessed by means of the block and box test
Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)
Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Muscular tone assessed by the Modified Ashworth Scale
Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale
Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months 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 13 Jun 2019.
- Derived from this study: PubMed 31158553Salazar AP, Cimolin V, Schifino GP, Rech KD, Marchese RR, Pagnussat AS. Bi-cephalic transcranial direct current stimulation combined with functional electrical stimulation for upper-limb stroke rehabilitation: A double-blind randomized controlled trial. Ann Phys Rehabil Med. 2020 Jan;63(1):4-11. doi: 10.1016/j.rehab.2019.05.004. Epub 2019 May 31.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation (FES) and Combination of Transcranial direct brain stimulation (tDCS) and FES 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 13 Jun 2019. 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?
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) (time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)). 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 NCT02818608, 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 13 Jun 2019.