Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis (EMG-BFB)
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| ClinicalTrials.gov Identifier: NCT02974465 |
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Recruitment Status :
Completed
First Posted : November 28, 2016
Last Update Posted : December 11, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Electromyography | Procedure: Biofeedback Electromyography Procedure: Sham Biofeedback Electromyography Procedure: Conventional Physical Therapy Treatment | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis: A Randomized Controlled Clinical Trial |
| Study Start Date : | November 2016 |
| Actual Primary Completion Date : | September 2017 |
| Actual Study Completion Date : | February 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Experimental Group
protocol of Biofeedback Electromyography plus conventional physical therapy treatment
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Procedure: Biofeedback Electromyography
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. Procedure: Conventional Physical Therapy Treatment 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… |
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Sham Comparator: Control Group
consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
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Procedure: Sham Biofeedback Electromyography
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. Procedure: Conventional Physical Therapy Treatment 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… |
- 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
- range of motion [ Time Frame: 10 minutes ]Articular goniometer
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| Ages Eligible for Study: | 15 Years to 55 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974465
| Study Director: | Maria Torres Lacomba, PhD | University of Alcalá |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cristina Lirio Romero, Physiotherapist, University of Alcala |
| ClinicalTrials.gov Identifier: | NCT02974465 |
| Other Study ID Numbers: |
UNIALCALA |
| First Posted: | November 28, 2016 Key Record Dates |
| Last Update Posted: | December 11, 2018 |
| Last Verified: | November 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Brain injuries upper extremity biofeedback electromyography recovery of function |
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Paresis Neurologic Manifestations Nervous System Diseases |