Efficacy of Lycra Garments in Ataxic Subjects

Not Applicable

• Conditions: Ataxia, Cerebellar

• Registration Number: NCT04830904
• Lead Sponsor: IRCCS Eugenio Medea

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-08-03
• Study First Submitted: 2021-03-11
• Study First Submitted QC: 2021-03-31
• Study First Posted: 2021-04-05
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-24
• Last Update Posted: 2021-08-25
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale/ with lycra garments	immediately after wearing the lycra garment	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)
6 Minute Walking Test/no device	immediately before wearing the lycra garment	a test to assess the walking resistance
Goal Attainment Scaling/ with lycra garments	immediately after wearing the lycra garment	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)
Movement of the center of mass over GRAIL/no device	immediately before wearing the lycra garment	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
Berg Balance Scale/no device	immediately before wearing the lycra garment	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)
6 Minute Walking Test/ with lycra garments	immediately after wearing the lycra garment	a test to assess the walking resistance
Movement of the center of mass over GRAIL/ with lycra garments	immediately after wearing the lycra garment	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
Goal Attainment Scaling/no device	immediately before wearing the 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)

Secondary Outcome Measures

Name	Time	Method
Likert tolerability questionaire	14 days after wearing the lycra garment	a likert tool designed to evaluate the tolerability of the lycra garments

Trial Locations

Locations (1)

IRCCS E. Medea; 🇮🇹 Bosisio Parini, Lecco, Italy