"Equistasi" and Gait in Hemiparesis

NCT ID: NCT02714478

Last Updated: 2016-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Brief Summary

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

Detailed Description

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Conditions

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Hemiparesis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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treatment

3 "Equistasi" devices will be placed during physiotherapy, 5 times per week, for 4 weeks

Group Type EXPERIMENTAL

equistasi

Intervention Type DEVICE

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

controls

3 "placebo" devices will be placed during physiotherapy, 5 times per week, for 4 weeks

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Generale Di Zona Moriggia-Pelascini

OTHER

Sponsor Role lead

Responsible Party

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Ilaria Zivi

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Brain Injury and Parkinson Disease Rehabilitation, "Moriggia-Pelascini" Hospital

Gravedona, CO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Frazzitta, MD

Role: CONTACT

Phone: +39033492705

Email: [email protected]

Facility Contacts

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Giuseppe Frazzitta, MD

Role: primary

Other Identifiers

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Equistasi.01

Identifier Type: -

Identifier Source: org_study_id