StrokeFES-ABLENCT03967613
Functional Eletrical Stimulation in Post Stroke Patients
A study testing Functional eletrical stimulation in people with Stroke, run by School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP) at 1 site in Portugal.
Trial summary
The FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Functional eletrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Jun 2019to 26 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First and unilateral ischemic or hemorrhagic stroke, in the middle cerebral artery, confirmed by imaging;
- Age equal ou greater than 30 years old;
- Preserved congnitive function, corresponding to a score higher than 23 in the Mini Mental State Examination (MMSE);
- Ability to perform active movement in the contralesional upper limb (UL) of at least 15° in the shoulder and elbow.
Who cannot join
- Body mass index (BMI) less than 18,5 and greater than 30;
- Hemi-spatial neglect and/or uncorrected visual changes;
- Musculoskeletal or neurological conditions which may affect ULs and/or trunk function;
- Pain in the ULs;
- Severe sensorimotor impairment, corresponding to a score less than 39 in the Fugl-Meyer Assessment Scale - Upper Extremity (FMAS-UE);
- Lesions on the skin of the affected forearm;
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- Severe spasticity (modified Ashworth >3);
- Severe muscle contractures on the affected forearm;
- Pacemaker;
- Osteosynthesis or metallic implants;
- Pregnancy;
- Adverse skin reaction to electrodes' gel.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of an Intervention Based on a Multichannel Functional Electrical Stimulation (FES) Prototype on the Upper Limb Movement Quality in Post Stroke Patients
The FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks. The results of this project will contribute to the definition of the therapeutic window of FES to improve upper limb function in stroke rehabilitation.
- Conditions
- Stroke
- Being tested
- Functional eletrical stimulation
- Keywords
- Functional eletrical stimulation, Stroke, Upper limb
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional eletrical stimulationDevice
Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks
| Study group | Role | What they receive |
|---|---|---|
| FES | Experimental | Functional Eletrical Stimulation Receives: Device: Functional eletrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematic metrics change
End-point kinematics and joint kinematics will be analyzed. Regarding end-point kinematics, to evaluate speed, the absolute and relative movement times will be calculated separately for each phase and for the entire tasks, as well as the peak velocity for reach, forward and backward transport and return phases. To assess efficiency, smoothness and control strategy of movement, the índex of curvature, the number of velocity peaks (or number of motor units) and the time to peak velocity will be respectively calculated for reach, forward and backward transport and return phases.
Regarding joint kinematics, joint angles5 of shoulder, elbow and wrist at onset of each phase will be calculated, as well as maximum aperture and time to maximum aperture in reach and return phases, and trunk displacement (to measure compensation) for each phase.
Measured: Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months
Secondary outcomes (1)
User satisfaction
Participants' satisfaction will be assessed through an adaptation of the Reduced Upper Extremity Motor Activity Log Questionnaire. In this adapted questionnaire, the participant will be asked to classify the use of the arm in function of the quantity (0 - not used;1 - very rarely; 2 - rarely; 3 -half pre-stroke; 4- 3/4 pre-stroke; 5 - same as pre-stroke.) and quality (0 - not used.1 - very poor.2 - poor.3 - fair.4 - almost normal.5 - normal.) in the evaluated tasks.
Measured: User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start15 Jun 2019
- Primary completion30 Nov 2019
- Study completion26 Dec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación General CSIC, Center for Rehabilitation Research (CIR), Tecnalia
- Responsible party
- Principal investigator, Rubim Santos, Polytechnic Institute of Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967613
- Sponsor's protocol ID
- 0348/CIE/ 6_E
- Acronym
- FES-ABLE
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2018
- Last updated
- 30 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sousa ASP, Mesquita IA, Costa da Silva CI, Silva A, Macedo R, Imatz-Ojanguren E, Hernandez E, Keller T, Moreira J, Pereira da Fonseca PF, Santos R. Optimal Multifield Functional Electrical Stimulation Parameters for the "Turn on the Light" Task and Related Upper Limb Kinematics Repeatability in Poststroke Subjects. Arch Phys Med Rehabil. 2021 Jun;102(6):1180-1190. doi: 10.1016/j.apmr.2020.10.135. Epub 2020 Nov 27.
PubMed 33253692
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intervention Based on a Multichannel Functional Electrical Stimulation (FES) Prototype on the Upper Limb Movement Quality in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT03967613
- Acronym / sponsor ID
- FES-ABLE / 0348/CIE/ 6_E
- Conditions
- Stroke
- Keywords
- Functional eletrical stimulation, Stroke, Upper limb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)University, hospital or other
- Collaborators
- Fundación General CSIC, Center for Rehabilitation Research (CIR), Tecnalia
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 26 Dec 2019 (actual)
- First posted
- 30 May 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 FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks. The results of this project will contribute to the definition of the therapeutic window of FES to improve upper limb function in stroke rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES | Experimental | Device: Functional eletrical stimulationFunctional Eletrical Stimulation |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First and unilateral ischemic or hemorrhagic stroke, in the middle cerebral artery, confirmed by imaging;
- Age equal ou greater than 30 years old;
- Preserved congnitive function, corresponding to a score higher than 23 in the Mini Mental State Examination (MMSE);
- Ability to perform active movement in the contralesional upper limb (UL) of at least 15° in the shoulder and elbow.
Key exclusion criteria (12 listed)
- Body mass index (BMI) less than 18,5 and greater than 30;
- Hemi-spatial neglect and/or uncorrected visual changes;
- Musculoskeletal or neurological conditions which may affect ULs and/or trunk function;
- Pain in the ULs;
- Severe sensorimotor impairment, corresponding to a score less than 39 in the Fugl-Meyer Assessment Scale - Upper Extremity (FMAS-UE);
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 eletrical stimulationAplication of functional eletrical stimulation on contralesional upper limb during functional tasks | Device | FES |
Primary outcome
Kinematic metrics change
Time frame: Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months
End-point kinematics and joint kinematics will be analyzed. Regarding end-point kinematics, to evaluate speed, the absolute and relative movement times will be calculated separately for each phase and for the entire tasks, as well as the peak velocity for reach, forward and backward transport and return phases. To assess efficiency, smoothness and control strategy of movement, the índex of curvature, the number of velocity peaks (or number of motor units) and the time to peak velocity will be respectively calculated for reach, forward and backward transport and return phases. Regarding joint kinematics, joint angles5 of shoulder, elbow and wrist at onset of each phase will be calculated, as well as maximum aperture and time to maximum aperture in reach and return phases, and trunk displacement (to measure compensation) for each phase.
1 secondary outcome
User satisfaction
Time frame: User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months
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 30 Dec 2019.
- Derived from this study: PubMed 33253692Sousa ASP, Mesquita IA, Costa da Silva CI, Silva A, Macedo R, Imatz-Ojanguren E, Hernandez E, Keller T, Moreira J, Pereira da Fonseca PF, Santos R. Optimal Multifield Functional Electrical Stimulation Parameters for the "Turn on the Light" Task and Related Upper Limb Kinematics Repeatability in Poststroke Subjects. Arch Phys Med Rehabil. 2021 Jun;102(6):1180-1190. doi: 10.1016/j.apmr.2020.10.135. Epub 2020 Nov 27.
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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 eletrical stimulation in people with Stroke, run by School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP) at 1 site in Portugal.
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 12 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 30 Dec 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 Portugal. 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 metrics change (time frame: Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months). 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 NCT03967613, 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 30 Dec 2019.