"Equistasi" and Gait in Hemiparesis
Efficacy of "Equistasi" on the Gait of Patients Affected by Hemiparesis Due to Cerebrovascular Accident
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 10, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedSeptember 30, 2016
September 1, 2016
1.7 years
March 10, 2016
September 29, 2016
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (2)
treatment
EXPERIMENTAL3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
controls
PLACEBO COMPARATOR3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks
Interventions
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
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
Eligibility Criteria
You may qualify if:
- subacute hemiparesis
- Functional Ambulation Classification \<4
You may not qualify if:
- previous neurological deficits
- Glasgow Coma Scale \<13
- Complete sensory deficit in the lower limbs
- Levels of Cognitive Functioning ≤5
- polyneuropathy
- contraindications to mobilization/verticalization
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital
Gravedona, CO, 22015, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 10, 2016
First Posted
March 21, 2016
Study Start
April 1, 2015
Primary Completion
December 1, 2016
Last Updated
September 30, 2016
Record last verified: 2016-09