Efficacy of Lycra Garments in Ataxic Subjects

NCT ID: NCT04830904

Last Updated: 2021-08-25

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

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-12-31

Brief Summary

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The aim of this study iss to analyze the effect of Lycra garments in the axial stabilization in subjects affected by ataxia, both in acquired cerebellar injuries and malformative etiology.

Improvement are expected for what concerns:

* greater stability during stance
* smoother walking pattern
* reduction of risk of fall.

The two groups (acquired and malformative) will be compared.

Detailed Description

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Conditions

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Ataxia, Cerebellar

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Use of lycra garments

the subjects are assessed with and without wearing the device

Group Type EXPERIMENTAL

personalized Lycra garments

Intervention Type DEVICE

the subjects wear lycra garments during the assessment time and for some days after the assessment

Interventions

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personalized Lycra garments

the subjects wear lycra garments during the assessment time and for some days after the assessment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* subjects recruited must show a framework of ataxia consequent to acquired brain injury or malformative etiology.
* subjects must be able to walk autonomously without any device

Exclusion Criteria

* presence of spasticity or muscular contractures
* subjects who already used lycra garments
Minimum Eligible Age

4 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Eugenio Medea

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS E. Medea

Bosisio Parini, Lecco, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Daniele Panzeri

Role: CONTACT

031877878

Facility Contacts

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Daniele Panzeri

Role: primary

031877878

Other Identifiers

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760

Identifier Type: -

Identifier Source: org_study_id

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