Hemiparesis
Conditions
Brief summary
The purpose of the study is to evaluate the effect of Equistasi device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.
Interventions
DEVICEequistasi
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
DEVICEplacebo
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
Sponsors
Ospedale Generale Di Zona Moriggia-Pelascini
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* subacute hemiparesis * Functional Ambulation Classification \<4
Exclusion criteria
* previous neurological deficits * Glasgow Coma Scale \<13 * Complete sensory deficit in the lower limbs * Levels of Cognitive Functioning ≤5 * polyneuropathy * contraindications to mobilization/verticalization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disability change assessed using Functional Independence Measure scale | 0. 30. 60. 120 days |
| balance change assessed using Berg Balance Scale | 0. 30. 60. 120 days |
| gait pattern change assessed using Functional Ambulation Classification scale | 0. 30. 60. 120 days |
| gait speed change assessed using Timed Up and Go scale | 0. 30. 60. 120 days |
| gait pattern change using Tinetti scale for gait | 0. 30. 60. 120 days |
| gait speed change assessed using 10 meter walking test scale | 0. 30. 60. 120 days |
| swaying of the center of gravity change assessed with stabilometric platform indexes | 0. 30. 60. 120 days |
Countries
Italy
Contacts
Primary ContactGiuseppe Frazzitta, MD
Outcome results
None listed