Efficacy of Lycra Garments in Ataxic Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Ataxia, Cerebellar
• Intervention / Treatment: Device: personalized Lycra garments

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniele Panzeri; Phone Number: 031877878; Email: daniele.panzeri@lanostrafamiglia.it

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • Recruiting
      • IRCCS E. Medea
      • Contact: Daniele Panzeri; Phone Number: 031877878; Email: daniele.panzeri@lanostrafamiglia.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 31, 2021
• First Posted (Actual): April 5, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Cerebellar Diseases; Ataxia; Cerebellar Ataxia
• Other Study ID Numbers: 760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No