"Equistasi" and Gait in Hemiparesis

Hemiparesis Clinical Trial

Official title:

Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02714478
• Other study ID #: Equistasi.01
• Status: Recruiting
• Phase: Phase 4
• First received: March 10, 2016
• Last updated: September 29, 2016
• Start date: April 2015

Study information

• Verified date: September 2016
• Source: Ospedale Generale Di Zona Moriggia-Pelascini
• Contact: Giuseppe Frazzitta, MD
• Phone: +39033492705
• Email: frazzittag62[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Paresis

Intervention

Device:
• 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

Locations

Country	Name	City	State
Italy	Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital	Gravedona	CO

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Generale Di Zona Moriggia-Pelascini

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disability change assessed using Functional Independence Measure scale		0. 30. 60. 120 days	No
Primary	balance change assessed using Berg Balance Scale		0. 30. 60. 120 days	No
Primary	gait pattern change assessed using Functional Ambulation Classification scale		0. 30. 60. 120 days	No
Primary	gait speed change assessed using Timed Up and Go scale		0. 30. 60. 120 days	No
Primary	gait pattern change using Tinetti scale for gait		0. 30. 60. 120 days	No
Primary	gait speed change assessed using 10 meter walking test scale		0. 30. 60. 120 days	No
Primary	swaying of the center of gravity change assessed with stabilometric platform indexes		0. 30. 60. 120 days	No