Back to resultsEfficacy of Lycra Garments in Ataxic Subjects
Primary Purpose
Ataxia, Cerebellar
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
personalized Lycra garments
Sponsored by
About this trial
This is an interventional supportive care trial for Ataxia, Cerebellar
Eligibility Criteria
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
Sites / Locations
- IRCCS E. MedeaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Use of lycra garments
Arm Description
the subjects are assessed with and without wearing the device
Outcomes
Primary Outcome Measures
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
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
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)
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)
6 Minute Walking Test/no device
a test to assess the walking resistance
6 Minute Walking Test/ with lycra garments
a test to assess the walking resistance
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)
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)
Secondary Outcome Measures
Likert tolerability questionaire
a likert tool designed to evaluate the tolerability of the lycra garments
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04830904
Brief Title
Efficacy of Lycra Garments in Ataxic Subjects
Official Title
Efficacy of Lycra Garments in Ataxic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Eugenio Medea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ataxia, Cerebellar
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Use of lycra garments
Arm Type
Experimental
Arm Description
the subjects are assessed with and without wearing the device
Intervention Type
Device
Intervention Name(s)
personalized Lycra garments
Intervention Description
the subjects wear lycra garments during the assessment time and for some days after the assessment
Primary Outcome Measure Information:
Title
Movement of the center of mass over GRAIL/no device
Description
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
Time Frame
immediately before wearing the lycra garment
Title
Movement of the center of mass over GRAIL/ with lycra garments
Description
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
Time Frame
immediately after wearing the lycra garment
Title
Berg Balance Scale/no device
Description
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)
Time Frame
immediately before wearing the lycra garment
Title
Berg Balance Scale/ with lycra garments
Description
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)
Time Frame
immediately after wearing the lycra garment
Title
6 Minute Walking Test/no device
Description
a test to assess the walking resistance
Time Frame
immediately before wearing the lycra garment
Title
6 Minute Walking Test/ with lycra garments
Description
a test to assess the walking resistance
Time Frame
immediately after wearing the lycra garment
Title
Goal Attainment Scaling/no device
Description
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)
Time Frame
immediately before wearing the device
Title
Goal Attainment Scaling/ with lycra garments
Description
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)
Time Frame
immediately after wearing the lycra garment
Secondary Outcome Measure Information:
Title
Likert tolerability questionaire
Description
a likert tool designed to evaluate the tolerability of the lycra garments
Time Frame
14 days after wearing the lycra garment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniele Panzeri
Phone
031877878
Email
daniele.panzeri@lanostrafamiglia.it
Facility Information:
Facility Name
IRCCS E. Medea
City
Bosisio Parini
State/Province
Lecco
ZIP/Postal Code
23842
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Panzeri
Phone
031877878
Email
daniele.panzeri@lanostrafamiglia.it
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Lycra Garments in Ataxic Subjects
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