Ataxia, CerebellarNCT04830904
Efficacy of Lycra Garments in Ataxic Subjects
A study testing personalized Lycra garments in people with Ataxia, Cerebellar, run by IRCCS Eugenio Medea at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Ataxia, Cerebellar
- What is being tested?
- personalized Lycra garments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 3 Aug 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- presence of spasticity or muscular contractures
- subjects who already used lycra garments
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS E. Medea
Bosisio Parini, Lecco, 23842
Daniele Panzeri, 031877878, daniele.panzeri@lanostrafamiglia.it
About this study
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.
- Conditions
- Ataxia, Cerebellar
- Being tested
- personalized Lycra garments
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized Lycra garmentsDevice
the subjects wear lycra garments during the assessment time and for some days after the assessment
| Study group | Role | What they receive |
|---|---|---|
| Use of lycra garments | Experimental | the subjects are assessed with and without wearing the device Receives: Device: personalized Lycra garments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: immediately after wearing the lycra garment
6 Minute Walking Test/no device
a test to assess the walking resistance
Measured: immediately before wearing the lycra garment
6 Minute Walking Test/ with lycra garments
a test to assess the walking resistance
Measured: 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)
Measured: 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)
Measured: immediately after wearing the lycra garment
Secondary outcomes (1)
Likert tolerability questionaire
a likert tool designed to evaluate the tolerability of the lycra garments
Measured: 14 days after wearing the lycra garment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2021
- Study start3 Aug 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxia, CerebellarStudies of the same condition, open and under way.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04830904
- Sponsor's protocol ID
- 760
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Lycra Garments in Ataxic Subjects
- ClinicalTrials.gov ID
- NCT04830904
- Acronym / sponsor ID
- 760
- Conditions
- Ataxia, Cerebellar
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 5 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of lycra garments | Experimental | Device: personalized Lycra garmentsthe subjects are assessed with and without wearing the device |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- presence of spasticity or muscular contractures
- subjects who already used lycra garments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| personalized Lycra garmentsthe subjects wear lycra garments during the assessment time and for some days after the assessment | Device | Use of lycra garments |
Primary outcome
Movement of the center of mass over GRAIL/no device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: immediately before wearing the lycra garment
a test to assess the walking resistance
6 Minute Walking Test/ with lycra garments
Time frame: immediately after wearing the lycra garment
a test to assess the walking resistance
Goal Attainment Scaling/no device
Time frame: 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)
Goal Attainment Scaling/ with lycra garments
Time frame: 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)
1 secondary outcome
Likert tolerability questionaire
Time frame: 14 days after wearing the lycra garment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized Lycra garments in people with Ataxia, Cerebellar, run by IRCCS Eugenio Medea at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniele Panzeri (031877878, daniele.panzeri@lanostrafamiglia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement of the center of mass over GRAIL/no device (time frame: immediately before wearing the lycra garment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.