Visual Cognitive DeficitsNCT02061501
Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
A study testing Optometric therapy during 6 months and Optometric therapy during 12 months in people with Visual Cognitive Deficits, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Visual Cognitive Deficits
- What is being tested?
- Optometric therapy during 6 months and Optometric therapy during 12 months
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to Jun 2017
- 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- visual cognitive deficits
- normal intelligence
Who cannot join
- cerebral palsy
- mental deficiency
- visual acuity deficit
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CRTLA - Hôpital de Hautepierre- CHRU Strasbourg
Strasbourg, 67098
Anne de Saint-Martin, MD, 03 88 12 83 28 ext. +33, anne.desaintmartin@chru-strasbourg.fr
Anne de Saint-Martin, MD
About this study
Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed.
We aim to evaluate the efficacy of such therapy by a comparative study between two groups of children aged between 5 and 12 after 6 months of rehabilitation.
- Conditions
- Visual Cognitive Deficits
- Being tested
- Optometric therapy during 6 months, Optometric therapy during 12 months
- Keywords
- visual cognitive deficits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optometric therapy during 6 monthsOther
Optometric therapy during 6 months, once a week
Optometric therapy during 12 monthsOther
Optometric therapy once a week, during 12 months
| Study group | Role | What they receive |
|---|---|---|
| Speech therapy | Active comparator | Speech therapy (30 min per week) alone for the 6 first months. Then speech therapy (30 min per week) and optometric therapy (30 min per week) for the 6 last months. Receives: Other: Optometric therapy during 6 months |
| Speech therapy and optometric therapy | Experimental | Speech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months. Receives: Other: Optometric therapy during 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of a composite score at Visit 1
The composite score is calculated from the results obtained at several neuropsychology and optometric tests.
Basal score is calculated at Visit 0 (inclusion visit).
Measured: Visit 1 (6 months of rehabilitation)
Secondary outcomes (1)
Calculation of a composite score at Visit 2
The composite score is calculated from the results obtained at several neuropsychology and optometric tests.
Measured: Visit 2 (12 months of rehabilitation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Cognitive DeficitsStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061501
- Sponsor's protocol ID
- 5542
- Status last verified
- Jun 2014
- First submitted
- 10 Feb 2014
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Optometric Rehabilitation on Visual Cognitive Deficits in Children
- ClinicalTrials.gov ID
- NCT02061501
- Acronym / sponsor ID
- 5542
- Conditions
- Visual Cognitive Deficits
- Keywords
- visual cognitive deficits
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 12 Feb 2014 (estimated)
- 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.
Visual cognitive deficits in children are frequent, with an impact on working and daily activities. Optometric therapy may improve those functions, however few studies have been performed.
We aim to evaluate the efficacy of such therapy by a comparative study between two groups of children aged between 5 and 12 after 6 months of rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speech therapy | Active comparator | Other: Optometric therapy during 6 monthsSpeech therapy (30 min per week) alone for the 6 first months. Then speech therapy (30 min per week) and optometric therapy (30 min per week) for the 6 last months. |
| Speech therapy and optometric therapy | Experimental | Other: Optometric therapy during 12 monthsSpeech therapy (30 min per week) and optometric therapy (30 min per week) for 12 months. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- visual cognitive deficits
- normal intelligence
Key exclusion criteria (3 listed)
- cerebral palsy
- mental deficiency
- visual acuity deficit
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 |
|---|---|---|
| Optometric therapy during 6 monthsOptometric therapy during 6 months, once a week | Other | Speech therapy |
| Optometric therapy during 12 monthsOptometric therapy once a week, during 12 months | Other | Speech therapy and optometric therapy |
Primary outcome
Calculation of a composite score at Visit 1
Time frame: Visit 1 (6 months of rehabilitation)
The composite score is calculated from the results obtained at several neuropsychology and optometric tests. Basal score is calculated at Visit 0 (inclusion visit).
1 secondary outcome
Calculation of a composite score at Visit 2
Time frame: Visit 2 (12 months of rehabilitation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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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 Optometric therapy during 6 months and Optometric therapy during 12 months in people with Visual Cognitive Deficits, run by University Hospital, Strasbourg, France 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 2 inclusion and 3 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 23 Jun 2014. 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 Anne de Saint Martin, MD (03 88 12 83 28 ext. +33, anne.desaintmartin@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of a composite score at Visit 1 (time frame: Visit 1 (6 months of rehabilitation)). 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 23 Jun 2014.