Clinical trial NCT02974465: Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis
Official title: Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromyography
Keywords: Brain injuries
upper extremity
biofeedback
electromyography
recovery of function
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2016-11-28
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* peripheral nerve injury, fractures of upper limb, cervical radiculopathy, complete luxation of the shoulder and severe cognitive impairment.

Primary outcomes:
measure: Fugl-Meyer Upper-Extremity Scale (FMA-UE)
timeFrame: 15 minutes
Secondary outcomes:
measure: range of motion
timeFrame: 10 minutes
Other outcomes:
Locations:
Study officials:
affiliation: University of Alcalá
name: Maria Torres Lacomba, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Giggins OM, Persson UM, Caulfield B. Biofeedback in rehabilitation. J Neuroeng Rehabil. 2013 Jun 18;10:60. doi: 10.1186/1743-0003-10-60.
citation: De 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.
citation: Lirio-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.