Phase
Condition
Cerebral Ischemia
Stroke
Treatment
Exoskeleton stroke group
Clinical Study ID
Ages 30-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy subjects
Age 30-75 anni;
50 kg ≤ weight ≤90 kg
150 cm ≤ height ≤ 192 cm
Thigh length: 355 ÷ 475 mm;
Length of tibia: 405 ÷ 485 mm;
Width pelvis: 690 ÷ 990 mm;
Shoe number: 36 ÷ 45
Subjects with stroke
Age 30-75 anni;
50 kg ≤ Weight ≤90 kg
150 cm ≤ Height ≤ 192 cm
Thigh length: 355 ÷ 475 mm;
Length of tibia: 405 ÷ 485 mm;
Pelvic width: 690 ÷ 990 mm;
Shoe number: 36 ÷ 45;
Stroke diagnosis at least 3 months and within 24 months;
First unilateral haemorrhagic or ischemic stroke classified as complete orpartial infarction of the anterior circulation and infarction of the lacunarcirculation (Oxford Stroke Classification: TACS -Total Anterior CirculationStroke, PACS - Partial Anterior Circulation Stroke, LACS -Lacunar Stroke).These criteria may include hemiplegia, hemianopia, motor and/or sensorydeficits, and disturbance/impairment of superior cortical and subcorticalfunction;
FAC (Functional Ambulation Category) 1, 2 and 3 (subjects with ambulationdependent on supervisor or continuous or intermittent physical assistance);
At least MRC (Medical Research Council) of the triceps surae equal to 1 orgreater (required to produce the biofeedback tone or for exoskeleton control).
Exclusion
Exclusion Criteria:
Healthy subjects
Prosthetic implants
Musculoskeletal, neurological, cardiovascular and pulmonary disorders that mayimpair gait;
State of pregnancy or breastfeeding.
Exclusion criteria
Subjects with stroke
Mini Mental State Examination < 23/30;
Clinical records of visuospatial and ideomotor apraxia, behavioral disorders (e.g. depression, aggression), neglect, major visual impairment and severeosteoporosis;
Non stabilized fractures;
Cranial injury;
Other diseases attributable to cardio-respiratory problemsi;
State of pregnancy or breastfeeding;
Previous or concurrent neoplastic malignancy;
Chronic inflammatory diseases with joint involvement of the lower limbs;
Serious spasticity (Ashworth>3);
Pelvic fractures and unstable column;
Significant limitations of passive ROM of hips and knees;
Problems with skin integrity at the interface surfaces with the device or thatwould prevent sitting.
Study Design
Study Description
Connect with a study center
Fondazione Don Carlo Gnocchi IRCCS
Milan, 20148
ItalySite Not Available
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