Oral-Linguo-Facial PraxiesCo-VISNCT04639427
Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases
An observational study of Oral-Linguo-Facial Praxies and Covid19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral-Linguo-Facial Praxies, Covid19
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 8 Feb 2021to Jul 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 4 patients hospitalized in the adult neurological Post Intensive Care Rehabilitation Unit (PICRU - SRPR) of Raymond Poincaré hospital.
Who may be able to join
- Aged >= 18 years;
- Hospitalization for more than 2 weeks prior to enrollment in the adult post intensive care rehabilitation care unit (PICRU) of Raymond Poincaré hospital in Garches;
- With oral-linguo-facial praxis disorders whatever the cause;
- Has been informed and not in opposition to participation of the study.
Who cannot join
- Patient with fever or any suspect symptom of a SARS-CoV2 infection;
- Planned discharge of hospital in 2 weeks;
- Patient with cognitive, phasic or vigilance disorders preventing to understand the study;
- Under guardianship or curator;
- Patient Under french AME scheme.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité de Soins de Rééducation Post Réanimation, Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
Garches, 92380
About this study
The primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic.
Read the detailed description
Statistic analysis: single case experimental design (SCED) method.
- Conditions
- Oral-Linguo-Facial Praxies, Covid19
- Keywords
- Oral-Linguo-Facial praxies, Covid19, speech therapy rehabilitation
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral-Linguo-Facial Motricity Test
Measured: throughtout of the study, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start8 Feb 2021
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral-Linguo-Facial PraxiesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie PAQUEREAU, MD, Principal investigator, Unité de Soins de Rééducation Post Réanimation, Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04639427
- Sponsor's protocol ID
- APHP200876
- Other IDs
- IDRCB
- Acronym
- Co-VIS
- Status last verified
- Jul 2021
- First submitted
- 19 Nov 2020
- Last updated
- 14 Jul 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 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Using a Transparent Visor to Replace the Face Mask in Speech Therapy Rehabilitation of Oral-Linguo-Facial Praxies in the Context of COVID-19: a Series of Cases
- ClinicalTrials.gov ID
- NCT04639427
- Acronym / sponsor ID
- Co-VIS / APHP200876
- Conditions
- Oral-Linguo-Facial Praxies, Covid19
- Keywords
- Oral-Linguo-Facial praxies, Covid19, speech therapy rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 20 Nov 2020 (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 primary objective of the study is to compare the effectiveness of the use of a transparent covering visor with that of the face mask, with or without the use of video sequences, for speech therapy rehabilitation of oral-linguo-facial praxies in the context of the COVID 19 epidemic.
Detailed description
Statistic analysis: single case experimental design (SCED) method.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 4 patients hospitalized in the adult neurological Post Intensive Care Rehabilitation Unit (PICRU - SRPR) of Raymond Poincaré hospital.
Key inclusion criteria (4 listed)
- Aged >= 18 years;
- Hospitalization for more than 2 weeks prior to enrollment in the adult post intensive care rehabilitation care unit (PICRU) of Raymond Poincaré hospital in Garches;
- With oral-linguo-facial praxis disorders whatever the cause;
- Has been informed and not in opposition to participation of the study.
Key exclusion criteria (5 listed)
- Patient with fever or any suspect symptom of a SARS-CoV2 infection;
- Planned discharge of hospital in 2 weeks;
- Patient with cognitive, phasic or vigilance disorders preventing to understand the study;
- Under guardianship or curator;
- Patient Under french AME scheme.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral-Linguo-Facial Motricity Test
Time frame: throughtout of the study, an average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No
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.
Julie PAQUEREAU, MD principal investigator
Unité de Soins de Rééducation Post Réanimation, Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré, APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral-Linguo-Facial Praxies and Covid19, run by Assistance Publique - Hôpitaux de Paris 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: status not confirmed, as of the sponsor's last update on 14 Jul 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 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. 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 Julie PAQUEREAU, MD (+ 33 (0)1 47 10 79 00, julie.paquereau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral-Linguo-Facial Motricity Test (time frame: throughtout of the study, an average of 2 weeks). 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 14 Jul 2021.