Effects of Neuromuscular Electrical Stimulation in Muscle Architecture and Functionality of Patients After Acute Stroke

NCT03840954 | Unknown

• 1 other identifier: 20180460
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Stroke is a sudden illness, responsible for important neurological and cognitive sequelae that can result in functional limitations and dependence. It is the leading cause of neurological impairment in young adults and resting-related muscle loss is one of the major factors involved. Early rehabilitation is essential for these patients and neuromuscular electrical stimulation (NMES) has been identified as an intervention alternative due to its known effects on the prevention of muscle loss in patients with various pathologies. Objective: To evaluate the effects of NMES associated with conventional physiotherapy compared to conventional physiotherapy on muscle thickness and functionality of patients with acute stroke. Methodology: This is a randomized clinical trial, which will be performed at the Emergency and Unit Unit of the Stroke of the Hospital de Clínicas of Porto Alegre (HCPA). Patients with acute stroke, with up to 72 hours of hospital admission, who present with lower limb force deficit due to the current stroke will be included. Patients will be randomized into two groups: intervention group, who will receive the application of NMES associated with conventional physiotherapy and control group, who will receive the conventional physiotherapy of the HCPA. NMES training will be applied once a day (30 minutes of application per session with an increase of five minutes each week and gradual reduction in OFF time), five days a week until hospital discharge or up to a maximum of three weeks. The following outcomes will be assessed before and after the intervention: quadriceps and tibial thickness and quality of the quadriceps and tibialis anterior, muscle strength, stroke severity, gait, functionality and disability.

Conditions

Stroke, Acute; Neuromuscular Electrical Stimulation

Outcome Measures

Primary Outcomes (2)

• Quadriceps muscle thickness

  Evaluated by muscular echography (cm)

  three weeks

• Thickness of the anterior tibial muscle

  Evaluated by muscular echography (cm)

  three weeks

Secondary Outcomes (8)

• Functionality - Barthel Index for Activities of Daily Living

  three weeks

• Muscle strength - Medical Research Council (MRC) Scale

  three weeks

• Functional walking - Functional Ambulation Categories

  three weeks

• Dynamometry - Knee extension

  three weeks

• Dynamometry - ankle dorsiflexion

  three weeks

Study Arms (2)

Neuromuscular Electrical Stimulation

EXPERIMENTAL

The experimental group will receive the application of NMES associated with conventional physiotherapy. After the NMES application, conventional physiotherapy will be performed. The exercises performed will be according to the patient's physical condition, and the conducts will always be performed seeking the maximum possible functional performance for the patient. The conducts adopted according to the standard routine of the HCPA stroke unit are: passive, active, assisted and / or active exercises; muscle stretching; selective hip extension; trunk stabilization training in sedestation; orthostasis training and walking training.

Other: Neuromuscular Electrical Stimulation

Group Control

NO INTERVENTION

The control group will only receive conventional physiotherapy, composed of the same exercises performed in the experimental group.

Interventions

Neuromuscular Electrical Stimulation OTHER

The application of NMES will be performed with the patient positioned in the supine position in the bed. Self-adhesive electrodes will be positioned at the motor points of the quadriceps and anterior tibial muscles respectively. A symmetrical biphasic pulsed current with a frequency of 80 Hz, a pulse width of 500 μs and an intensity at the motor threshold will be applied up to the maximum tolerated by the patient. ON and OFF time and total session time will be used according to protocol with progressive increase of the total intervention time and reduction of OFF time of the NMES. The device used will be the Neurodyn II model, manufactured by IBRAMED. Patients will receive NMES for as long as they remain hospitalized or for up to 3 weeks.

Neuromuscular Electrical Stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of ischemic or hemorrhagic stroke performed by a neurologist based on clinical and neuroimaging characteristics;
• To present motor sequelae in the lower limb due to stroke.

You may not qualify if:

• Previous motor deficits
• Complete recovery of motor deficits before the initial evaluation;
• Conditions that prevent neuromuscular electrical stimulation such as skin lesions at the site of electrode placement, pacemaker and therapy intolerance.
• Time greater than 72 hours since hospitalization.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

HCPA

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Graciele Sbruzzi, doctor

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Graciele Sbruzzi, doctor

CONTACT

+55(51)33577334; gsbruzzi@hcpa.edu.br

Débora Schmidt

CONTACT

+55(51)33577334; dschmidt@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: February 15, 2019
• Study Start: August 30, 2019
• Primary Completion: May 30, 2022
• Study Completion: August 30, 2022
• Last Updated: July 1, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)