Stroke, ComplicationEMGBIO-ICTUSNCT03838809
Electromyography-biofeedback on the Motor Activation of the Extension of the Hand
A study testing surface electromyography-biofeedback in people with Stroke, Complication, run by Universidad Católica San Antonio de Murcia at 1 site in Spain.
Trial summary
Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent physiotherapy technique. Although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied. Read more about this study
- Who is it for?
- Ages 74 to 84 years
- Conditions the study is for
- Stroke, Complication
- What is being tested?
- surface electromyography-biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 8 Aug 2017to 1 Jun 2018
- 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 74 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients with a stroke
- Limitation of the hand and foot extension
Who cannot join
- Patients with some contraindication against the surface electromyography biofeedback technique, for instance, people with pacemaker, with cardiovascular antecedents, etc.
- Patients receiving other physiotherapy treatment 2 months before the beginning of the study
- Patients that decline to sign the informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Neurological Physiotherapy Program With Electromyography-biofeedback on the Motor Activation of the Extension of the Hand and Dorsiflexion of the Foot in Cerebrovascular Damage: A Randomized Clinical Trial
Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent physiotherapy technique. Although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied.
Objective: The purpose of this research was to determine the changes that occur in the application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of the hand and the foot in subjects with cerebrovascular damage.
Read more
Design: A randomized, double-blind, two-arm parallel group study was performed.
Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the foot as a consequence of a stroke was randomized divided in intervention or control groups.
Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of 15-minute duration each of them, in the upper and lower members. On the other hand, the control group underwent another 12 sessions of 15-minute duration, in which manual physiotherapy techniques were performed.
- Conditions
- Stroke, Complication
- Being tested
- surface electromyography-biofeedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surface electromyography-biofeedbackDevice
Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.
| Study group | Role | What they receive |
|---|---|---|
| INTERVENTION | Experimental | A group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot Receives: Device: surface electromyography-biofeedback |
| CONTROL | Active comparator | A group that underwent a conventional physiotheraphy intervention Receives: Device: surface electromyography-biofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension Degree
Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles
Measured: 3 months
Secondary outcomes (1)
Fugl Meyer Test
Severity degree of the stroke-derived consequences
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start8 Aug 2017
- Primary completion30 Nov 2017
- Study completion1 Jun 2018
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 Stroke, ComplicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia
- Investigators
- Juan José Hernández Morante, PhD, Principal investigator, Catholic University of Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03838809
- Sponsor's protocol ID
- UCAM/UITA/03
- Acronym
- EMGBIO-ICTUS
- Status last verified
- Feb 2019
- First submitted
- 7 Feb 2019
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.
PubMed 31511629
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Neurological Physiotherapy Program With Electromyography-biofeedback on the Motor Activation of the Extension of the Hand and Dorsiflexion of the Foot in Cerebrovascular Damage: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03838809
- Acronym / sponsor ID
- EMGBIO-ICTUS / UCAM/UITA/03
- Conditions
- Stroke, Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 12 Feb 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.
Background: Biofeedback-Surface electromyography (BIO-SEMG) is a relatively recent physiotherapy technique. Although its use is widespread in sports science and sports performance, its use for the rehabilitation of patients with neurological pathologies is less studied.
Objective: The purpose of this research was to determine the changes that occur in the application of BIO-SEMG in the muscles responsible for the extension and the dorsiflexion of the hand and the foot in subjects with cerebrovascular damage.
Design: A randomized, double-blind, two-arm parallel group study was performed.
Patients: A sample of 28 subjects with limited extension of the hand and dorsiflexion of the foot as a consequence of a stroke was randomized divided in intervention or control groups.
Methods: The subjects of the intervention group underwent 12 sessions of BIO-SEMG, of 15-minute duration each of them, in the upper and lower members. On the other hand, the control group underwent another 12 sessions of 15-minute duration, in which manual physiotherapy techniques were performed.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INTERVENTION | Experimental | Device: surface electromyography-biofeedbackA group that underwent a neurological physiotherapy program with electromyography-biofeedback on the hand and the foot |
| CONTROL | Active comparator | Device: surface electromyography-biofeedbackA group that underwent a conventional physiotheraphy intervention |
Who may qualify
- Ages
- 74 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients with a stroke
- Limitation of the hand and foot extension
Key exclusion criteria (3 listed)
- Patients with some contraindication against the surface electromyography biofeedback technique, for instance, people with pacemaker, with cardiovascular antecedents, etc.
- Patients receiving other physiotherapy treatment 2 months before the beginning of the study
- Patients that decline to sign the informed consent.
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 |
|---|---|---|
| surface electromyography-biofeedbackTwo electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone. | Device | CONTROL, INTERVENTION |
Primary outcome
Extension Degree
Time frame: 3 months
Change in the extension ability of the upper an lower members depending on the activity of the extensor muscles
1 secondary outcome
Fugl Meyer Test
Time frame: 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 12 Feb 2019.
- Derived from this study: PubMed 31511629Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.
- Individual participant dataSharing planned: No
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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.
Juan José Hernández Morante, PhD principal investigator
Catholic University of 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 surface electromyography-biofeedback in people with Stroke, Complication, run by Universidad Católica San Antonio de Murcia 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 2 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 12 Feb 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 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?
Extension Degree (time frame: 3 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 NCT03838809, 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 12 Feb 2019.