Efficacy of Lycra Garments in Ataxic Subjects

Study Overview
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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.

Official Title
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Efficacy of Lycra Garments in Ataxic Subjects

Conditions
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Ataxia, Cerebellar

Intervention / Treatment
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* Device: personalized Lycra garments


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Use of lycra garments<br>the subjects are assessed with and without wearing the device | Device: personalized Lycra garments<br>* the subjects wear lycra garments during the assessment time and for some days after the assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement of the center of mass over GRAIL/no device | Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetitions lasting 1 minute | immediately before wearing the lycra garment | 
| Movement of the center of mass over GRAIL/ with lycra garments | Balance in static conditions and Walking assessment over GRAIL. GRAIL will be used to track the movement of the Center Of Mass of the patient during 4 repetition lasting 1 minute | immediately after wearing the lycra garment | 
| Berg Balance Scale/no device | Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome) | immediately before wearing the lycra garment | 
| Berg Balance Scale/ with lycra garments | Berg Balance Scale is a scale to assess the risk of fall and balance failure. It ranges from 0 (worse outcome) to 56 (best outcome) | immediately after wearing the lycra garment | 
| 6 Minute Walking Test/no device | a test to assess the walking resistance | immediately before wearing the lycra garment | 
| 6 Minute Walking Test/ with lycra garments | a test to assess the walking resistance | immediately after wearing the lycra garment | 
| Goal Attainment Scaling/no device | Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better) | immediately before wearing the device | 
| Goal Attainment Scaling/ with lycra garments | Goal Attainment Scaling is a subjective scale that can be defined between clinicians and subjects (or their parents) to identify changes in specific activities. It should be articulated up to 3 goals, and each of them should be scored with values ranging from -2 (worse score) to +2 (better) | immediately after wearing the lycra garment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert tolerability questionaire | a likert tool designed to evaluate the tolerability of the lycra garments | 14 days after wearing the lycra garment |