Clinical trial NCT04494685: Effects of Robotic Rehabilitation in Post-Stroke Patients
Official title: Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Robotics
Electric stimulation
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Functionality
timeFrame: Baseline, after 3 weeks and after 6 weeks
Secondary outcomes:
measure: Muscle strength
timeFrame: Baseline, after 3 weeks and after 6 weeks.
measure: Quadriceps muscle thickness
timeFrame: Baseline and after 6 weeks
measure: Echogenicity of the rectus femoris muscle
timeFrame: Baseline and after 6 weeks
measure: Spasticity
timeFrame: Baseline, after after 3 weeks and after 6 weeks
measure: Mobility
timeFrame: After 3 weeks and after 6 weeks
measure: Disability and dependence
timeFrame: Baseline and after 6 weeks
measure: Quality of life indicator
timeFrame: Baseline and after 6 weeks
measure: Heart rate
timeFrame: From the 1st to the 18th day/session
measure: Peripheral arterial oxygen saturation
timeFrame: From the 1st to the 18th day/session
measure: Systolic blood pressure
timeFrame: From the 1st to the 18th day/session
measure: Diastolic blood pressure
timeFrame: From the 1st to the 18th day/session
measure: Muscle pain
timeFrame: From the 1st to the 18th day/session
measure: Lower limb fatigue
timeFrame: From the 1st to the 18th day/session
measure: Time of hospital stay
timeFrame: From the 1st to the last day of hospitalization
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Health Sciences of Porto Alegre
name: Rodrigo DM Plentz, PhD
role: PRINCIPAL_INVESTIGATOR
References: