Effects of Robotic Rehabilitation in Post-Stroke Patients
1 other identifier
interventional
40
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Aug 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 29, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedStudy Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedJuly 31, 2020
July 1, 2020
6 months
May 29, 2020
July 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Functionality
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.
Baseline, after 3 weeks and after 6 weeks
Secondary Outcomes (14)
Muscle strength
Baseline, after 3 weeks and after 6 weeks.
Quadriceps muscle thickness
Baseline and after 6 weeks
Echogenicity of the rectus femoris muscle
Baseline and after 6 weeks
Spasticity
Baseline, after after 3 weeks and after 6 weeks
Mobility
After 3 weeks and after 6 weeks
- +9 more secondary outcomes
Study Arms (2)
Robotic rehabilitation
EXPERIMENTALRobotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland).
Conventional physiotherapy
ACTIVE COMPARATORThe 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rodrigo DM Plentz, PhD
Federal University of Health Sciences of Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 29, 2020
First Posted
July 31, 2020
Study Start
August 1, 2020
Primary Completion
February 1, 2021
Study Completion
December 31, 2021
Last Updated
July 31, 2020
Record last verified: 2020-07