"Equistasi" and Gait in Hemiparesis

Recruiting

Phase 4 Results N/A

Trial Description

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

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: controls
    Description: 3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
  • Equistasi Device
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: treatment
    Description: 3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks

Trial Design

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

Outcomes

Type Measure 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

Sponsors