"Equistasi" and Gait in Hemiparesis

Phase 4

• Conditions: Hemiparesis
• Interventions: Device: equistasi; Device: placebo

• Registration Number: NCT02714478
• Lead Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2016-03-10
• Study First Submitted QC: 2016-03-15
• Study First Posted: 2016-03-21
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-29
• Last Update Posted: 2016-09-30
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment	equistasi	3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
controls	placebo	3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks

Primary Outcome Measures

Name	Time	Method
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 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
gait pattern change using Tinetti scale for gait	0. 30. 60. 120 days

Trial Locations

Locations (1)

Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital; 🇮🇹 Gravedona, CO, Italy