"Equistasi" and Gait in Hemiparesis

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

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

Study Overview

• Status: Unknown
• Conditions: Hemiparesis
• Intervention / Treatment: Device: equistasi; Device: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Giuseppe Frazzitta, MD; Phone Number: +39033492705; Email: frazzittag62@gmail.com

Study Locations

• Italy
  • CO
    • Gravedona, CO, Italy, 22015
      • Recruiting
      • Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital
      • Contact: Giuseppe Frazzitta, MD; Phone Number: +39033492705; Email: frazzittag62@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment; 3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks	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 Comparator: controls; 3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Ospedale Generale Di Zona Moriggia-Pelascini

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 15, 2016
• First Posted (Estimate): March 21, 2016

Study Record Updates

• Last Update Posted (Estimate): September 30, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: Equistasi.01