Electromyographic Biofeedback and Physical Therapy in Upper Limb Hemiparesis

Not Applicable

Completed

• Conditions: Electromyography
• Interventions: Procedure: Sham Biofeedback Electromyography; Procedure: Biofeedback Electromyography; Procedure: Conventional Physical Therapy Treatment

• Registration Number: NCT02974465
• Lead Sponsor: University of Alcala

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.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-20
• Study First Submitted QC: 2016-11-22
• Study First Posted: 2016-11-28
• Primary Completion: 2017-09
• Study Completion: 2018-02
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sham Biofeedback Electromyography	consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
Experimental Group	Conventional Physical Therapy Treatment	protocol of Biofeedback Electromyography plus conventional physical therapy treatment
Control Group	Conventional Physical Therapy Treatment	consisted of Sham- Biofeedback Electromyography plus conventional physical therapy treatment
Experimental Group	Biofeedback Electromyography	protocol of Biofeedback Electromyography plus conventional physical therapy treatment

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Upper-Extremity Scale (FMA-UE)	15 minutes	Assess functionality found in the motor recruitment of the paretic shoulder muscles after brain injury

Secondary Outcome Measures

Name	Time	Method
range of motion	10 minutes	Articular goniometer