Ataxia, Cerebellar
Conditions
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.
Interventions
DEVICEpersonalized Lycra garments
the subjects wear lycra garments during the assessment time and for some days after the assessment
Sponsors
IRCCS Eugenio Medea
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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) |
| 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 |
| 6 Minute Walking Test/ with lycra garments | immediately after wearing the lycra garment | a test to assess the walking resistance |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Likert tolerability questionaire | 14 days after wearing the lycra garment | a likert tool designed to evaluate the tolerability of the lycra garments |
Countries
Italy
Contacts
Primary ContactDaniele Panzeri
Outcome results
None listed