Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
50 participants
INTERVENTIONAL
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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treatment
3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
equistasi
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
controls
3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
placebo
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
Interventions
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equistasi
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
placebo
3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
Eligibility Criteria
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Inclusion Criteria
* Functional Ambulation Classification \<4
Exclusion Criteria
* Glasgow Coma Scale \<13
* Complete sensory deficit in the lower limbs
* Levels of Cognitive Functioning ≤5
* polyneuropathy
* contraindications to mobilization/verticalization
18 Years
80 Years
ALL
No
Sponsors
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Ospedale Generale Di Zona Moriggia-Pelascini
OTHER
Responsible Party
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Ilaria Zivi
MD
Locations
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Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital
Gravedona, CO, Italy
Countries
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Central Contacts
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Facility Contacts
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Giuseppe Frazzitta, MD
Role: primary
Other Identifiers
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Equistasi.01
Identifier Type: -
Identifier Source: org_study_id