Effects of Robotic Rehabilitation in Post-Stroke Patients

Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial

This study aims to evaluate the effect of robotic rehabilitation through training on a robot-assisted orthostatic board and neuromuscular electrical stimulation (NMES) on functionality in post-stroke patients. In this randomized controlled trial the patients will be allocated to a control group (which will receive conventional physiotherapy) or or to intervention group (which will receive conventional physiotherapy and robotic rehabilitation). Interventions will occur every day in the hospital phase and three times/week after discharge, totaling 18 sessions.The groups will be evaluated prior to any physiotherapy intervention, in the 10h session and at the end of six weeks of treatment (or 18 sessions).The following outcomes will be measured: functionality, peripheral muscle strength, muscle architecture and echogenicity, spasticity, cardiorespiratory repercussions, mobility, disability and dependence, quality of life and time of hospital stay.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Device: Intervention group (Robotic rehabilitation); Other: Control group (Conventional physiotherapy)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rodrigo DM Plentz, PhD; Phone Number: +555191131651; Email: roplentz@yahoo.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Medical diagnosis of ischemic stroke, in the subacute phase (after 48 hours);
• To present hemiparesis or muscle weakness defined by the Medical Research Council (MRC) score;
• To understand simple commands and being able to report signs of discomfort.

Exclusion Criteria:

• Severe psychomotor agitation;
• Recent acute myocardial infarction (24 hours) and/or uncontrolled arrhythmias;
• Intracranial hypertension (PIC> 20mmHg);
• Uncontrolled hypertension (PAS> 230 mmHg and PAD> 120 mmHg) or PAM <60 mmHg;
• Decompensated heart failure;
• To present important hemodynamic changes during training;
• Peripheral vascular disease in the lower limb such as untreated deep vein thrombosis;
• Unconsolidated fractures or severe joint pain;
• Feverish state;
• Smokers;
• Epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
• Pre-existing neuromuscular disease;
• Signs of rhabdomyolysis;
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic rehabilitation; Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).	Device: Intervention group (Robotic rehabilitation); Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis.; Other Names: Erigo®
Active Comparator: Conventional physiotherapy; The protocol will be based on lower limb exercises, aiming at maintaining and gaining muscle strength through passive, assisted or active mobilization, when possible, on the affected side.	Other: Control group (Conventional physiotherapy); Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functionality	The change in functionality will be assessed using the Fugl-Meyer Scale. This scale consists of six domains: range of motion, pain, sensitivity, motor function of the upper and lower extremities, balance, coordination and speed. The score for each item ranges from 0 to 2, where 0 = cannot be performed; 1 = partially accomplished; 2 = completely accomplished. The total score ranges from 0 to 266 points and the higher the score the better the functionality.	Baseline, after 3 weeks and after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength	The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)	Baseline, after 3 weeks and after 6 weeks.
Quadriceps muscle thickness	The change in quadriceps muscle thickness will be evaluated for the acquisition of ultrasound images using a high resolution ultrasound device (Vivid-i, GE, USA). In order to verify the thickness of the muscle, the distance between the superficial and deep aponeurosis is measured.The thickness is given in centimeters.	Baseline and after 6 weeks
Echogenicity of the rectus femoris muscle	The change in echogenicity will be evaluated for the acquisition of ultrasound images of the rectus femoris muscle using a high resolution ultrasound device (Vivid-i, GE, USA). To check the echogenicity of the rectus femoris an image of the cross-sectional area of the muscle will be taken. The echogenicity measurement is given in an arbitrary unit.	Baseline and after 6 weeks
Spasticity	The change in spasticity will be assessed by the Modified Ashworth Scale. This scale consists of an ordinal classification of 5 points for grading the resistance found during passive stretching, with 0 indicating normal muscle tone and 4 severe increase in tone. The higher the score, the greater the spasticity.	Baseline, after after 3 weeks and after 6 weeks
Mobility	The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor	After 3 weeks and after 6 weeks
Disability and dependence	The change in disability and dependency will be assessed using the Modified Rankin Scale. This instrument has 6 scores, where: 0 = asymptomatic; 1 = symptoms without disabilities; 2 = mild disability; 3 = moderate disability; 4 = moderate to severe disability; 5 = severe disability and 6 = death. The higher the score, the greater the degree of disability and dependence.	Baseline and after 6 weeks
Quality of life indicator	The change in quality of life will be assessed using the EuroQol-5D questionnaire. This is a generic instrument that assesses mobility, personal care, usual activities, pain and anxiety/depression. It allows to generate a global index of the value of an individual's health status. The number 1 indicates the best state of health (perfect health) and 0 the worst state of health (death).	Baseline and after 6 weeks
Heart rate	Heart rate will be assessed by pulse oximetry	From the 1st to the 18th day/session
Peripheral arterial oxygen saturation	Peripheral arterial oxygen saturation will be assessed by pulse oximetry	From the 1st to the 18th day/session
Systolic blood pressure	Systolic blood pressure will be assessed through sphygmomanometer	From the 1st to the 18th day/session
Diastolic blood pressure	Diastolic blood pressure will be assessed through sphygmomanometer	From the 1st to the 18th day/session
Muscle pain	Pain perception will be assessed using the Visual Analog Scale. This scale ranges from 0 to 10, where 0 indicates no pain and 10 maximum pain.	From the 1st to the 18th day/session
Lower limb fatigue	Lower limb fatigue will be assessed by Borg effort subjective perception scale. This scale ranges from 0 to 10, where 0 indicates no effort or fatigue and 10 indicates maximum effort.	From the 1st to the 18th day/session
Time of hospital stay	The days between admission and hospital discharge will be counted	From the 1st to the last day of hospitalization

Collaborators and Investigators

• Sponsor: Federal University of Health Science of Porto Alegre

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 31, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Stroke; Robotics; Electric stimulation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Stroke_ERIGO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No