GeriatricsEqui-tee-shirtNCT04146675
Evaluation of a T-shirt "Balance" Containing Ceramic Fibers
A study testing TRICOT JERSEY VANISE DOUBLE FACE and TRICOT JERSEY SIMPLE in people with Geriatrics, run by University Hospital, Lille at 1 site in France.
Trial summary
Falls are frequent and often serious events in the elderly. The consequences of falls are often severe: traumatic (fractures, hematomas, ..) and psychological. Falls are among the top ten causes of death in this population and, for people older than 70, falls are the leading cause of accidental death. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatrics
- What is being tested?
- TRICOT JERSEY VANISE DOUBLE FACE and TRICOT JERSEY SIMPLE
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Presenting disturbances of balance (determined by a Tinetti test score strictly greater than 12)
- Hold the balance while standing with his feet and arms along the body and walk for 3 meters without major imbalance that may cause a fall
- Consent to participate in the study (a signed written consent form)
- Covered by a social security system
Who cannot join
- A motor deficit of the lower limbs focused and characterized by neurological or orthopedic cause (for example hemiplegia after a cerebrovascular accident, limb amputation).
- Inability to receive the protocol information
- Inability to participate in the entire study
- Absence of a social security coverage
- Refusal to sign the Informed Consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for the Evaluation of a T-shirt "Balance" Containing Ceramic Fibers
Falls are frequent and often serious events in the elderly. The consequences of falls are often severe: traumatic (fractures, hematomas, ..) and psychological. Falls are among the top ten causes of death in this population and, for people older than 70, falls are the leading cause of accidental death.
The Damart company has developed a fabric containing ceramic fibers. Clothes containing such fibers have been found to improve balance.
Read more
This study aims to measure the effect of a t-shirt with a ceramic membrane ("ceramic" t-shirt) on the balance and walking compared to the effect of a "placebo" t-shirt (same weight, appearance and texture).
The hypothesis is that wearing the ceramic tee-shirt significantly improves balance and walking, suggesting that it can also reduce falls - the main consequence of the balance and walking disorder.
- Conditions
- Geriatrics
- Being tested
- TRICOT JERSEY VANISE DOUBLE FACE, TRICOT JERSEY SIMPLE
- Keywords
- Gerontology, elderly,, falls, balance and walking disorders.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRICOT JERSEY VANISE DOUBLE FACEDevice
Short sleeve t-shirt : TRICOT JERSEY VANISE DOUBLE FACE " THERMOLACTYL EVOLUTION " with ceramic fibers.
A Tinetti test will be performed while wearing the T-shirt, as well as an evaluation of the equilibration on posturography platform under static conditions and an assessment of dynamic equilibrium and locomotion in motion analysis.
TRICOT JERSEY SIMPLEDevice
Short sleeve t-shirt : TRICOT JERSEY SIMPLE The comparator T-shirt has the same weight, the same appearance, and will be used by patients in the same way and under the same conditions as the T-shirt with ceramic fibers.
| Study group | Role | What they receive |
|---|---|---|
| TRICOT JERSEY VANISE DOUBLE FACE | Experimental | Not described Receives: Device: TRICOT JERSEY VANISE DOUBLE FACE |
| TRICOT JERSEY SIMPLE | Placebo comparator | Not described Receives: Device: TRICOT JERSEY SIMPLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the Tinetti score between the two group
Variation of the Tinetti score between the group T-shirt placebo (Δ Tinetti T-shirt placebo vs Tinetti clothing patients) and the ceramic tee-shirt group (Δ Tinetti ceramic t-shirt vs Tinetti clothing patients).
Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2.
A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score.
Measured: Baseline
Secondary outcomes (2)
variation of the posturography technique
Parameters of the static equilibrium produced by the posturography technique: the length of the balancing path (mm)
Measured: Baseline
variation of motion analysis (the optoelectronic system (VICON®)
Parameters of the dynamic equilibrium and locomotion produced by the technique of motion analysis.
Analysis of gait parameters: speed (seconde) and length (meters). these parameters will be combined to report the dynamic equilibrium and locomotion
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study startDec 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Puisieux, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146675
- Sponsor's protocol ID
- 2013_06
- Other IDs
- 2013-A00727-38
- Acronym
- Equi-tee-shirt
- Status last verified
- Jan 2019
- First submitted
- 9 Jan 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of a T-shirt "Balance" Containing Ceramic Fibers
- ClinicalTrials.gov ID
- NCT04146675
- Acronym / sponsor ID
- Equi-tee-shirt / 2013_06
- Conditions
- Geriatrics
- Keywords
- Gerontology, elderly,, falls, balance and walking disorders.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 31 Oct 2019 (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.
Falls are frequent and often serious events in the elderly. The consequences of falls are often severe: traumatic (fractures, hematomas, ..) and psychological. Falls are among the top ten causes of death in this population and, for people older than 70, falls are the leading cause of accidental death.
The Damart company has developed a fabric containing ceramic fibers. Clothes containing such fibers have been found to improve balance.
This study aims to measure the effect of a t-shirt with a ceramic membrane ("ceramic" t-shirt) on the balance and walking compared to the effect of a "placebo" t-shirt (same weight, appearance and texture).
The hypothesis is that wearing the ceramic tee-shirt significantly improves balance and walking, suggesting that it can also reduce falls - the main consequence of the balance and walking disorder.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRICOT JERSEY VANISE DOUBLE FACE | Experimental | Device: TRICOT JERSEY VANISE DOUBLE FACE |
| TRICOT JERSEY SIMPLE | Placebo comparator | Device: TRICOT JERSEY SIMPLE |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Presenting disturbances of balance (determined by a Tinetti test score strictly greater than 12)
- Hold the balance while standing with his feet and arms along the body and walk for 3 meters without major imbalance that may cause a fall
- Consent to participate in the study (a signed written consent form)
- Covered by a social security system
Key exclusion criteria (5 listed)
- A motor deficit of the lower limbs focused and characterized by neurological or orthopedic cause (for example hemiplegia after a cerebrovascular accident, limb amputation).
- Inability to receive the protocol information
- Inability to participate in the entire study
- Absence of a social security coverage
- Refusal to sign the Informed Consent form
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 |
|---|---|---|
| TRICOT JERSEY VANISE DOUBLE FACEShort sleeve t-shirt : TRICOT JERSEY VANISE DOUBLE FACE " THERMOLACTYL EVOLUTION " with ceramic fibers. A Tinetti test will be performed while wearing the T-shirt, as well as an evaluation of the equilibration on posturography platform under static conditions and an assessment of dynamic equilibrium and locomotion in motion analysis. | Device | TRICOT JERSEY VANISE DOUBLE FACE |
| TRICOT JERSEY SIMPLEShort sleeve t-shirt : TRICOT JERSEY SIMPLE The comparator T-shirt has the same weight, the same appearance, and will be used by patients in the same way and under the same conditions as the T-shirt with ceramic fibers. | Device | TRICOT JERSEY SIMPLE |
Primary outcome
Variation of the Tinetti score between the two group
Time frame: Baseline
Variation of the Tinetti score between the group T-shirt placebo (Δ Tinetti T-shirt placebo vs Tinetti clothing patients) and the ceramic tee-shirt group (Δ Tinetti ceramic t-shirt vs Tinetti clothing patients). Scoring of the Tinetti Assessment Tool is done on a three point ordinal scale with a range of 0 to 2. A score of 0 represents the most impairment, while a score of 2 represents independence. The individual scores are then combined to form three measures; an overall gait assessment score, and overall balance assessment score, ad a combined gait and balance score.
2 secondary outcomes
variation of the posturography technique
Time frame: Baseline
variation of motion analysis (the optoelectronic system (VICON®)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
François Puisieux, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRICOT JERSEY VANISE DOUBLE FACE and TRICOT JERSEY SIMPLE in people with Geriatrics, run by University Hospital, Lille at 1 site in France.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 31 Oct 2019. 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 France. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of the Tinetti score between the two group (time frame: Baseline). 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 31 Oct 2019.