Effects of Robotic Rehabilitation in Post-Stroke Patients

Not Applicable

• Conditions: Stroke
• Interventions: Other: Control group (Conventional physiotherapy); Device: Intervention group (Robotic rehabilitation)

• Registration Number: NCT04494685
• Lead Sponsor: Federal University of Health Science of Porto Alegre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-29
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-28
• Last Update Submitted: 2020-07-28
• Study First Posted: 2020-07-31
• Last Update Posted: 2020-07-31
• Study Start: 2020-08-01
• Primary Completion: 2021-02-01
• Study Completion: 2021-12-31

Recruitment & Eligibility

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

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physiotherapy	Control group (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.
Robotic rehabilitation	Intervention group (Robotic rehabilitation)	Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).

Primary Outcome Measures

Name	Time	Method
Functionality	Baseline, after 3 weeks and after 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Diastolic blood pressure	From the 1st to the 18th day/session	Diastolic blood pressure will be assessed through sphygmomanometer
Quadriceps muscle thickness	Baseline and after 6 weeks	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.
Mobility	After 3 weeks and after 6 weeks	The change in mobility will be assessed using the Timed Up and Go test (TUG), which will be associated with an inertial sensor
Peripheral arterial oxygen saturation	From the 1st to the 18th day/session	Peripheral arterial oxygen saturation will be assessed by pulse oximetry
Muscle strength	Baseline, after 3 weeks and after 6 weeks.	The change in muscle strength will be assessed by the Medical Research Council (MRC) scale and by test of maximum repetition (1RM)
Spasticity	Baseline, after after 3 weeks and after 6 weeks	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.
Quality of life indicator	Baseline and after 6 weeks	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).
Systolic blood pressure	From the 1st to the 18th day/session	Systolic blood pressure will be assessed through sphygmomanometer
Time of hospital stay	From the 1st to the last day of hospitalization	The days between admission and hospital discharge will be counted
Echogenicity of the rectus femoris muscle	Baseline and after 6 weeks	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.
Disability and dependence	Baseline and after 6 weeks	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.
Heart rate	From the 1st to the 18th day/session	Heart rate will be assessed by pulse oximetry
Lower limb fatigue	From the 1st to the 18th day/session	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.
Muscle pain	From the 1st to the 18th day/session	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.