Handicaps PhysicalDOME-6NCT03361696
Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment
An observational study of Handicaps Physical, run by University Hospital, Caen at 1 site in France.
Trial summary
The objective of this project is the realization of tests at home and in Hospitals or Functional Rehabilitation for the improvement of the communication with the family and medical entourage, the facility of the emotional expression, the evaluation of the pain, the control of home automation to increase their… Read more about this study
- Who is it for?
- Ages 2 to 80 years
- Conditions the study is for
- Handicaps Physical
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Apr 2017to 20 Dec 2020
- 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 2 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe disabilities either of traumatic origin or of neurological origin or Patients over 55 with loss of autonomy.
Who may be able to join
- Patients (2-80 years old) with complete or near complete motor disability of both upper limbs or four limbs: Sequelae of trauma or advanced rheumatologic disease (spinal cord injury, upper limb amputation, head trauma, chronic polyarthritis), Diseases Congenital (myopathies, agenesis upper limbs), sequelae of vascular accident (medullary infarction, syringomyelia), neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, conduction block neuropathy, etc ..).
- Patients older than 55 years without disability but with a loss of dependence.
- Troubles of the communication and loss of autonomy.
Who cannot join
- Patient with severe visual contraindications (decreased visual acuity with correction of ± 6/7 dioptres, major oculomotor abnormalities).
- Patients with significant cognitive impairment to understand simple instructions related to the use of the system
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this project is the realization of tests at home and in Hospitals or Functional Rehabilitation for the improvement of the communication with the family and medical entourage, the facility of the emotional expression, the evaluation of the pain, the control of home automation to increase their autonomy, facilitated their reintegration at home. The work is the last step of the research program started in 2009, with the optimization of the installation of the system, the improvement of physical and computer ergonomic aspects and the development of dedicated interfaces according to the type of disability and needs. of each one.
A work upstream of the definition of specifications taking into account the medical constraints was realized and the actions of improvement of the models, the algorithms, the robustness and the effectiveness of the treatment are in progress . The specific adaptation to concrete cases should lead to a system that allows 90% of the population of people with disabilities to exploit the system and significantly improve their level of communication, autonomy and in fact their daily lives.
- Conditions
- Handicaps Physical
- Being tested
- Help to use the Interface System of Communication and Control of the Environment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Help to use the Interface System of Communication and Control of the EnvironmentOther
the occupational therapist and the ergonomics engineers at the rate of 4 sessions per patient for periods of 2 to 3 hours help patient to use use the Interface System of Communication and Control of the Environment
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life questionnaire SF36
Measured: change over baseline and end of follow-up at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start20 Apr 2017
- Primary completion20 Apr 2020
- Study completion20 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Handicaps PhysicalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361696
- Sponsor's protocol ID
- 16-112
- Acronym
- DOME-6
- Status last verified
- Nov 2017
- First submitted
- 29 Nov 2017
- Last updated
- 1 Feb 2022
- 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 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment
- ClinicalTrials.gov ID
- NCT03361696
- Acronym / sponsor ID
- DOME-6 / 16-112
- Conditions
- Handicaps Physical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Dec 2020 (actual)
- First posted
- 5 Dec 2017 (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 objective of this project is the realization of tests at home and in Hospitals or Functional Rehabilitation for the improvement of the communication with the family and medical entourage, the facility of the emotional expression, the evaluation of the pain, the control of home automation to increase their autonomy, facilitated their reintegration at home. The work is the last step of the research program started in 2009, with the optimization of the installation of the system, the improvement of physical and computer ergonomic aspects and the development of dedicated interfaces according to the type of disability and needs. of each one.
A work upstream of the definition of specifications taking into account the medical constraints was realized and the actions of improvement of the models, the algorithms, the robustness and the effectiveness of the treatment are in progress . The specific adaptation to concrete cases should lead to a system that allows 90% of the population of people with disabilities to exploit the system and significantly improve their level of communication, autonomy and in fact their daily lives.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe disabilities either of traumatic origin or of neurological origin or Patients over 55 with loss of autonomy.
Key inclusion criteria (3 listed)
- Patients (2-80 years old) with complete or near complete motor disability of both upper limbs or four limbs: Sequelae of trauma or advanced rheumatologic disease (spinal cord injury, upper limb amputation, head trauma, chronic polyarthritis), Diseases Congenital (myopathies, agenesis upper limbs), sequelae of vascular accident (medullary infarction, syringomyelia), neurodegenerative diseases (amyotrophic lateral sclerosis, multiple sclerosis, conduction block neuropathy, etc ..).
- Patients older than 55 years without disability but with a loss of dependence.
- Troubles of the communication and loss of autonomy.
Key exclusion criteria (2 listed)
- Patient with severe visual contraindications (decreased visual acuity with correction of ± 6/7 dioptres, major oculomotor abnormalities).
- Patients with significant cognitive impairment to understand simple instructions related to the use of the system
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 |
|---|---|---|
| Help to use the Interface System of Communication and Control of the Environmentthe occupational therapist and the ergonomics engineers at the rate of 4 sessions per patient for periods of 2 to 3 hours help patient to use use the Interface System of Communication and Control of the Environment | Other | – |
Primary outcome
Quality of life questionnaire SF36
Time frame: change over baseline and end of follow-up at 6 month
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 1 Feb 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Handicaps Physical, run by University Hospital, Caen 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 3 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: finished, as of the sponsor's last update on 1 Feb 2022. 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?
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?
Quality of life questionnaire SF36 (time frame: change over baseline and end of follow-up at 6 month). 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 1 Feb 2022.