Effects of Robotic Rehabilitation in Post-Stroke Patients

NCT ID: NCT04494685

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2021-12-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robotic rehabilitation

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

Group Type: EXPERIMENTAL

Intervention group (Robotic rehabilitation)

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Control group (Conventional physiotherapy)

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Erigo®

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Rodrigo Della Méa Plentz

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rodrigo DM Plentz, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Health Sciences of Porto Alegre

Central Contacts

Rodrigo DM Plentz, PhD

Role: CONTACT

roplentz@yahoo.com.br

+555191131651

Other Identifiers

Stroke_ERIGO

Identifier Type: -

Identifier Source: org_study_id