ElectromyographyEMG-BFBNCT02974465
Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis
A study testing Biofeedback Electromyography and Conventional Physical Therapy Treatment in people with Electromyography, run by University of Alcala.
Trial summary
The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper limb hemiparesis added to conventional physical therapy on changes in upper extremity functionality, motor recruitment pattern and range of motion (ROM) compared to the single application of conventional physical therapy. Read more about this study
- Who is it for?
- Ages 15 to 55 years
- Conditions the study is for
- Electromyography
- What is being tested?
- Biofeedback Electromyography and Conventional Physical Therapy Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Feb 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 15 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- acquired brain injury after two months of medical evolution at least;
- suffer paretic upper limb;
- spasticity no greater than 3 in the modified Ashworth scale;
- minimum active ROM of 20º of glenohumeral abduction.
Who cannot join
- peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete luxation of the shoulder and severe cognitive impairment.
About this study
Official title: Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial
The aim of this study was to assess the effect of a specific protocol of sEMG-BFB in upper limb hemiparesis added to conventional physical therapy on changes in upper extremity functionality, motor recruitment pattern and range of motion (ROM) compared to the single application of conventional physical therapy. It aims to find a 22.22% difference between both interventions.
Read the detailed description
Upper limb hemiparesis is a common consequence after brain damage.
Objective: To evaluate the effect of a specific protocol of surface electromyographic biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle recruitment changes, and glenohumeral range of motion compared to the single application of conventional physical therapy.
Design: randomized controlled clinical trial.
Sample: 40 participants from State Center of Attention to Brain Injury were recruited.
Interventions: Patients were randomly assigned to 2 groups where the experimental group received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with hemiparesis and the control group received a placebo of the same technique. Both treatments were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity" for functionality and shoulder range of motion were objectified. Root mean square (RMS) value was assessed as a secondary measure Data were collected before and after intervention.
A protocol of sEMG-BFB in upper limb may have an important role in the recovery of subjects with upper limb hemiparesis.
- Conditions
- Electromyography
- Being tested
- Biofeedback Electromyography, Sham Biofeedback Electromyography, Conventional Physical Therapy Treatment
- Keywords
- Brain injuries, upper extremity, biofeedback, electromyography, recovery of function
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback ElectromyographyProcedure or surgery
protocol of sEMG-BFB that consisted of active movements in glenohumeral abduction guided by the visual signal of the register equipment. The protocol was the following: firstly proof active movements were requested in glenohumeral abduction without feeling any pain in order to teach the visual signal of their muscle activity. The therapist dedicated around 10 minutes in each session for subject learned to control the activation of both muscles in the limits that physical therapist marked with each individual in particular (controlling the activation in the upper trapezius). Once integrated information, shoulder abduction were requested following 4 main principles.
Sham Biofeedback ElectromyographyProcedure or surgery
consisted of Sham-EMG biofeedback, in which the electrodes were placed as the same method as the EG (Fig. 2) but the screen emit no signal. The subject performed 3 sequences of 10 abduction contractions (first degrees) without pain feeling and with 5 minutes of rest between sequences.
Conventional Physical Therapy TreatmentProcedure or surgery
All participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc…
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | protocol of Biofeedback Electromyography plus conventional physical therapy treatment Receives: Procedure: Biofeedback Electromyography; Procedure: Conventional Physical Therapy Treatment |
| Control Group | Sham comparator | consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment Receives: Procedure: Sham Biofeedback Electromyography; Procedure: Conventional Physical Therapy Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper-Extremity Scale (FMA-UE)
Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury
Measured: 15 minutes
Secondary outcomes (1)
range of motion
Articular goniometer
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ElectromyographyStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Lirio Romero, University of Alcala
- Investigators
- Maria Torres Lacomba, PhD, Study director, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974465
- Sponsor's protocol ID
- UNIALCALA
- Acronym
- EMG-BFB
- Status last verified
- Nov 2016
- First submitted
- 20 Nov 2016
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dogan-Aslan M, Nakipoglu-Yuzer GF, Dogan A, Karabay I, Ozgirgin N. The effect of electromyographic biofeedback treatment in improving upper extremity functioning of patients with hemiplegic stroke. J Stroke Cerebrovasc Dis. 2012 Apr;21(3):187-92. doi: 10.1016/j.jstrokecerebrovasdis.2010.06.006. Epub 2010 Sep 29.
PubMed 20880720Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
PubMed 23777436De Baets L, Jaspers E, Janssens L, Van Deun S. Characteristics of neuromuscular control of the scapula after stroke: a first exploration. Front Hum Neurosci. 2014 Nov 17;8:933. doi: 10.3389/fnhum.2014.00933. eCollection 2014.
PubMed 25477805Lirio-Romero C, Torres-Lacomba M, Gomez-Blanco A, Acero-Cortes A, Retana-Garrido A, de la Villa-Polo P, Sanchez-Sanchez B. Electromyographic biofeedback improves upper extremity function: a randomized, single-blinded, controlled trial. Physiotherapy. 2021 Mar;110:54-62. doi: 10.1016/j.physio.2020.02.002. Epub 2020 Feb 15.
PubMed 32718746
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02974465
- Acronym / sponsor ID
- EMG-BFB / UNIALCALA
- Conditions
- Electromyography
- Keywords
- Brain injuries, upper extremity, biofeedback, electromyography, recovery of function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Sep 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 28 Nov 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 was to assess the effect of a specific protocol of sEMG-BFB in upper limb hemiparesis added to conventional physical therapy on changes in upper extremity functionality, motor recruitment pattern and range of motion (ROM) compared to the single application of conventional physical therapy. It aims to find a 22.22% difference between both interventions.
Detailed description
Upper limb hemiparesis is a common consequence after brain damage.
Objective: To evaluate the effect of a specific protocol of surface electromyographic biofeedback (sEMG-BFB) and conventional physical therapy in upper limb functionality, muscle recruitment changes, and glenohumeral range of motion compared to the single application of conventional physical therapy.
Design: randomized controlled clinical trial.
Sample: 40 participants from State Center of Attention to Brain Injury were recruited.
Interventions: Patients were randomly assigned to 2 groups where the experimental group received sEMG-BFB for the upper trapezius and middle deltoid muscles of the upper limb with hemiparesis and the control group received a placebo of the same technique. Both treatments were applied for 6 weeks. The score of the Fugl-Meyer Assessment-Upper Extremity" for functionality and shoulder range of motion were objectified. Root mean square (RMS) value was assessed as a secondary measure Data were collected before and after intervention.
A protocol of sEMG-BFB in upper limb may have an important role in the recovery of subjects with upper limb hemiparesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Biofeedback Electromyography, Procedure: Conventional Physical Therapy Treatmentprotocol of Biofeedback Electromyography plus conventional physical therapy treatment |
| Control Group | Sham comparator | Procedure: Sham Biofeedback Electromyography, Procedure: Conventional Physical Therapy Treatmentconsisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- acquired brain injury after two months of medical evolution at least;
- suffer paretic upper limb;
- spasticity no greater than 3 in the modified Ashworth scale;
- minimum active ROM of 20º of glenohumeral abduction.
Key exclusion criteria (1 listed)
- peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete luxation of the shoulder and severe cognitive impairment.
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 |
|---|---|---|
| Biofeedback Electromyographyprotocol of sEMG-BFB that consisted of active movements in glenohumeral abduction guided by the visual signal of the register equipment. The protocol was the following: firstly proof active movements were requested in glenohumeral abduction without feeling any pain in order to teach the visual signal of their muscle activity. The therapist dedicated around 10 minutes in each session for subject learned to control the activation of both muscles in the limits that physical therapist marked with each individual in particular (controlling the activation in the upper trapezius). Once integrated information, shoulder abduction were requested following 4 main principles. | Procedure or surgery | Experimental Group |
| Sham Biofeedback Electromyographyconsisted of Sham-EMG biofeedback, in which the electrodes were placed as the same method as the EG (Fig. 2) but the screen emit no signal. The subject performed 3 sequences of 10 abduction contractions (first degrees) without pain feeling and with 5 minutes of rest between sequences. | Procedure or surgery | Control Group |
| Conventional Physical Therapy TreatmentAll participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc… | Procedure or surgery | Control Group, Experimental Group |
Primary outcome
Fugl-Meyer Upper-Extremity Scale (FMA-UE)
Time frame: 15 minutes
Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury
1 secondary outcome
range of motion
Time frame: 10 minutes
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 Dec 2018.
- Background: PubMed 20880720Dogan-Aslan M, Nakipoglu-Yuzer GF, Dogan A, Karabay I, Ozgirgin N. The effect of electromyographic biofeedback treatment in improving upper extremity functioning of patients with hemiplegic stroke. J Stroke Cerebrovasc Dis. 2012 Apr;21(3):187-92. doi: 10.1016/j.jstrokecerebrovasdis.2010.06.006. Epub 2010 Sep 29.
- Background: PubMed 23777436Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
- Results publication: PubMed 25477805De Baets L, Jaspers E, Janssens L, Van Deun S. Characteristics of neuromuscular control of the scapula after stroke: a first exploration. Front Hum Neurosci. 2014 Nov 17;8:933. doi: 10.3389/fnhum.2014.00933. eCollection 2014.
- Derived from this study: PubMed 32718746Lirio-Romero C, Torres-Lacomba M, Gomez-Blanco A, Acero-Cortes A, Retana-Garrido A, de la Villa-Polo P, Sanchez-Sanchez B. Electromyographic biofeedback improves upper extremity function: a randomized, single-blinded, controlled trial. Physiotherapy. 2021 Mar;110:54-62. doi: 10.1016/j.physio.2020.02.002. Epub 2020 Feb 15.
- 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.
Maria Torres Lacomba, PhD study director
University of Alcalá
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback Electromyography and Conventional Physical Therapy Treatment in people with Electromyography, run by University of Alcala.
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 1 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 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Fugl-Meyer Upper-Extremity Scale (FMA-UE) (time frame: 15 minutes). 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 NCT02974465, which also lists 4 linked publications.
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 Dec 2018.