NCT04830904

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 5, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

2.4 years

First QC Date

March 11, 2021

Last Update Submit

August 24, 2021

Conditions

Ataxia, Cerebellar

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (1)

  • Likert tolerability questionaire

    14 days after wearing the lycra garment

Study Arms (1)

Use of lycra garments

EXPERIMENTAL

the subjects are assessed with and without wearing the device

Device: personalized Lycra garments

Interventions

personalized Lycra garmentsDEVICE

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

Use of lycra garments

Eligibility Criteria

Age4 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • presence of spasticity or muscular contractures
  • subjects who already used lycra garments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

RECRUITING

MeSH Terms

Conditions

Cerebellar Ataxia

Condition Hierarchy (Ancestors)

Cerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAtaxiaDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Daniele Panzeri

CONTACT

031877878daniele.panzeri@lanostrafamiglia.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2021

First Posted

April 5, 2021

Study Start

August 3, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)