Effects of Robotic Rehabilitation in Post-Stroke Patients: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stroke
- Sponsor
- Federal University of Health Science of Porto Alegre
- Enrollment
- 40
- Primary Endpoint
- Functionality
- Last Updated
- 5 years ago
Overview
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.
Investigators
Rodrigo Della Méa Plentz
PhD
Federal University of Health Science of Porto Alegre
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;
- •Epidermal lesions on the thighs that make it impossible to place self-adhesive electrodes for electrical stimulation;
Outcomes
Primary Outcomes
Functionality
Time Frame: 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 Outcomes
- Diastolic blood pressure(From the 1st to the 18th day/session)
- Quadriceps muscle thickness(Baseline and after 6 weeks)
- Mobility(After 3 weeks and after 6 weeks)
- Peripheral arterial oxygen saturation(From the 1st to the 18th day/session)
- Muscle strength(Baseline, after 3 weeks and after 6 weeks.)
- Spasticity(Baseline, after after 3 weeks and after 6 weeks)
- Quality of life indicator(Baseline and after 6 weeks)
- Systolic blood pressure(From the 1st to the 18th day/session)
- Time of hospital stay(From the 1st to the last day of hospitalization)
- Echogenicity of the rectus femoris muscle(Baseline and after 6 weeks)
- Disability and dependence(Baseline and after 6 weeks)
- Heart rate(From the 1st to the 18th day/session)
- Lower limb fatigue(From the 1st to the 18th day/session)
- Muscle pain(From the 1st to the 18th day/session)