Back to results"Equistasi" and Gait in Hemiparesis
Primary Purpose
Hemiparesis
Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
equistasi
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis
Eligibility Criteria
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
Sites / Locations
- Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
treatment
controls
Arm Description
3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
Outcomes
Primary Outcome Measures
disability change assessed using Functional Independence Measure scale
balance change assessed using Berg Balance Scale
gait pattern change assessed using Functional Ambulation Classification scale
gait speed change assessed using Timed Up and Go scale
gait pattern change using Tinetti scale for gait
gait speed change assessed using 10 meter walking test scale
swaying of the center of gravity change assessed with stabilometric platform indexes
Secondary Outcome Measures
Full Information
NCT ID
NCT02714478
First Posted
March 10, 2016
Last Updated
September 29, 2016
Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
1. Study Identification
Unique Protocol Identification Number
NCT02714478
Brief Title
"Equistasi" and Gait in Hemiparesis
Official Title
Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Generale Di Zona Moriggia-Pelascini
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment
Arm Type
Experimental
Arm Description
3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
Arm Title
controls
Arm Type
Placebo Comparator
Arm Description
3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
Intervention Type
Device
Intervention Name(s)
equistasi
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
disability change assessed using Functional Independence Measure scale
Time Frame
0. 30. 60. 120 days
Title
balance change assessed using Berg Balance Scale
Time Frame
0. 30. 60. 120 days
Title
gait pattern change assessed using Functional Ambulation Classification scale
Time Frame
0. 30. 60. 120 days
Title
gait speed change assessed using Timed Up and Go scale
Time Frame
0. 30. 60. 120 days
Title
gait pattern change using Tinetti scale for gait
Time Frame
0. 30. 60. 120 days
Title
gait speed change assessed using 10 meter walking test scale
Time Frame
0. 30. 60. 120 days
Title
swaying of the center of gravity change assessed with stabilometric platform indexes
Time Frame
0. 30. 60. 120 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Frazzitta, MD
Phone
+39033492705
Email
frazzittag62@gmail.com
Facility Information:
Facility Name
Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital
City
Gravedona
State/Province
CO
ZIP/Postal Code
22015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Frazzitta, MD
Phone
+39033492705
Email
frazzittag62@gmail.com
12. IPD Sharing Statement
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"Equistasi" and Gait in Hemiparesis
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