Effects of Robotic Rehabilitation in Post-Stroke Patients

Federal University of Health Science of Porto Alegre

Status: Unknown

Conditions: Stroke

Treatments: Other: Control group (Conventional physiotherapy); Device: Intervention group (Robotic rehabilitation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04494685

Stroke_ERIGO

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Robotic rehabilitation

Experimental group

Description:

Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).

Treatment:

Device: Intervention group (Robotic rehabilitation)

Conventional physiotherapy

Active Comparator group

Description:

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.

Treatment:

Other: Control group (Conventional physiotherapy)