Efficacy of Lycra Garments in Ataxic Subjects

Ataxia, Cerebellar Clinical Trial

Official title:

Efficacy of Lycra Garments in Ataxic Subjects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04830904
• Other study ID #: 760
• Status: Recruiting
• Phase: N/A
• Start date: August 3, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: IRCCS Eugenio Medea
• Contact: Daniele Panzeri
• Phone: 031877878
• Email: daniele.panzeri[@]lanostrafamiglia.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Ataxia
• Ataxia, Cerebellar
• Cerebellar Ataxia

Intervention

Device:
• personalized Lycra garments
the subjects wear lycra garments during the assessment time and for some days after the assessment

Locations

Country	Name	City	State
Italy	IRCCS E. Medea	Bosisio Parini	Lecco

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Eugenio Medea

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	6 Minute Walking Test/no device	a test to assess the walking resistance	immediately before wearing the lycra garment
Primary	6 Minute Walking Test/ with lycra garments	a test to assess the walking resistance	immediately after wearing the lycra garment
Primary	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
Primary	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	Likert tolerability questionaire	a likert tool designed to evaluate the tolerability of the lycra garments	14 days after wearing the lycra garment