StrokePI52021RehabNCT04992910
Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute Stroke: a Pilot Randomised Controlled Trial
A study testing Functional electrical stimulation through medical device and Standard therapy in people with Stroke and Upper Extremity Paresis, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the feasibility, usability, and safety of multi-field FES-assisted therapy for hand rehabilitation in individuals with subacute stroke. A secondary, exploratory objective is to estimate preliminary effect sizes for distal upper-limb motor outcomes to inform the design of future… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- Functional electrical stimulation through medical device and Standard therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 14 Feb 2022to 1 Dec 2023
- 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
- 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
- Unilateral paresis
- Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment
Who cannot join
- Very severe proximal spasticity: Ashworth > 3.
- Psychiatric illness (including post-stroke depression).
- Cognitive impairment.
- Inability to provide informed consent.
- Other severe medical problems.
- Severe hemi-spatial neglect or anosognosia involving the affected arm.
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- Pacemakers
- Pregnant women.
- Skin ulcers.
- Peripheral neuropathies.
- Edema of the affected forearm and / or hand.
- Severe pain.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the feasibility, usability, and safety of multi-field FES-assisted therapy for hand rehabilitation in individuals with subacute stroke. A secondary, exploratory objective is to estimate preliminary effect sizes for distal upper-limb motor outcomes to inform the design of future adequately powered trials.
Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb.
- Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation)
- Control group - patients will receive standard care.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- Functional electrical stimulation through medical device, Standard therapy
- Keywords
- Stroke, Upper Extremity Paresis, Functional Electrical Stimulation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional electrical stimulation through medical deviceDevice
The patient will receive a therapy with functional electrical stimulation. For this, a device called "Fesia Grasp" will be used.
Duration: 80 min twice a week, for 6 weeks.
Standard therapyOther
Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Not described Receives: Device: Functional electrical stimulation through medical device |
| Standard Therapy | Active comparator | Not described Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrinsic Motivation Inventory (IMI)
This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'
Measured: 6 weeks
Adverse events
Any untoward medical occurrence during the clinical trial
Measured: 6 weeks
Usability questionnaire specifically designed for this study
It consists of a 5 item questionnaire with five response options (Likert sacle); from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients with the system and the therapy.
Measured: 6 weeks
Secondary outcomes (4)
Modified Ashworth Scale (MAS)
This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.
Measured: Baseline; 6 weeks; 3 months
Box & Blocks Test
It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other.
The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Measured: Baseline; 6 weeks; 3 months
Motor Activity Log (MAL)
Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).
Measured: Baseline; 6 weeks; 3 months
Fugl-Meyer Assessment (FMA) scale
It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start14 Feb 2022
- Primary completion1 Aug 2023
- Study completion1 Dec 2023
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimónides Biomedical Research Institute of Córdoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Mayordomo Riera, MD, Principal investigator, Hospital General Universitario Reina Sofía de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992910
- Sponsor's protocol ID
- PI52021Rehab
- Acronym
- PI52021Rehab
- Status last verified
- May 2026
- First submitted
- 16 Jul 2021
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be available for other investigators.
Publications
Guillen-Climent S, Casado-Adam P, Mejias-Ruiz M, Martin-Odriozola A, Rodriguez-de-Pablo C, Salcedo-Leal I, Sillero-Ruz E, Morente-Navajas MD, Flores-Lara M, Pena-Amaro J, Mayordomo-Riera FJ. Feasibility and safety of multi-field functional electrical stimulation for distal upper-limb rehabilitation after subacute stroke: a randomised controlled feasibility trial. Front Rehabil Sci. 2026 Sep 11;7:1920617. doi: 10.3389/fresc.2026.1920617. eCollection 2026.
PubMed 42799048
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute Stroke: a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04992910
- Acronym / sponsor ID
- PI52021Rehab / PI52021Rehab
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- Stroke, Upper Extremity Paresis, Functional Electrical Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Maimónides Biomedical Research Institute of CórdobaUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 5 Aug 2021 (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 purpose of this study is to evaluate the feasibility, usability, and safety of multi-field FES-assisted therapy for hand rehabilitation in individuals with subacute stroke. A secondary, exploratory objective is to estimate preliminary effect sizes for distal upper-limb motor outcomes to inform the design of future adequately powered trials.
Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb.
- Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation)
- Control group - patients will receive standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional Electrical Stimulation | Experimental | Device: Functional electrical stimulation through medical device |
| Standard Therapy | Active comparator | Other: Standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
- Unilateral paresis
- Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment
Key exclusion criteria (12 listed)
- Very severe proximal spasticity: Ashworth > 3.
- Psychiatric illness (including post-stroke depression).
- Cognitive impairment.
- Inability to provide informed consent.
- Other severe medical problems.
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 through medical deviceThe patient will receive a therapy with functional electrical stimulation. For this, a device called "Fesia Grasp" will be used. Duration: 80 min twice a week, for 6 weeks. | Device | Functional Electrical Stimulation |
| Standard therapyPhysical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks. | Other | Standard Therapy |
Primary outcome
Intrinsic Motivation Inventory (IMI)
Time frame: 6 weeks
This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'
Adverse events
Time frame: 6 weeks
Any untoward medical occurrence during the clinical trial
Usability questionnaire specifically designed for this study
Time frame: 6 weeks
It consists of a 5 item questionnaire with five response options (Likert sacle); from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients with the system and the therapy.
4 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Baseline; 6 weeks; 3 months
Box & Blocks Test
Time frame: Baseline; 6 weeks; 3 months
Motor Activity Log (MAL)
Time frame: Baseline; 6 weeks; 3 months
Fugl-Meyer Assessment (FMA) scale
Time frame: 6 weeks
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 27 May 2026.
- Derived from this study: PubMed 42799048Guillen-Climent S, Casado-Adam P, Mejias-Ruiz M, Martin-Odriozola A, Rodriguez-de-Pablo C, Salcedo-Leal I, Sillero-Ruz E, Morente-Navajas MD, Flores-Lara M, Pena-Amaro J, Mayordomo-Riera FJ. Feasibility and safety of multi-field functional electrical stimulation for distal upper-limb rehabilitation after subacute stroke: a randomised controlled feasibility trial. Front Rehabil Sci. 2026 Sep 11;7:1920617. doi: 10.3389/fresc.2026.1920617. eCollection 2026.
- Individual participant dataSharing planned: Yes. The results will be available for other investigators.
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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.
Fernando Mayordomo Riera, MD principal investigator
Hospital General Universitario Reina Sofía de Murcia
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 through medical device and Standard therapy in people with Stroke and Upper Extremity Paresis, run by Maimónides Biomedical Research Institute of Córdoba at 1 site in Spain.
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 3 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 27 May 2026. 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 Spain. 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?
Intrinsic Motivation Inventory (IMI) (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 NCT04992910, 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 27 May 2026.