"Equistasi" and Gait in Hemiparesis

Ospedale Generale Di Zona Moriggia-Pelascini

Status and phase: Unknown; Phase 4

Conditions: Hemiparesis

Treatments: Device: equistasi; Device: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02714478

Equistasi.01

Details and patient eligibility

About

The purpose of the study is to evaluate the effect of "Equistasi" device on quantitative and qualitative gait characteristics in patients affected by hemiparesis.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

treatment

Experimental group

Description:

3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks

Treatment:

Device: equistasi

controls

Placebo Comparator group

Description:

3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks

Treatment:

Device: placebo