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Completed

NCT Number: NCT03361696

Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment

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.

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Key information

Conditions

Handicaps Physical

Age range

2 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Help to use the Interface System of Communication and Control of the Environment

Other

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

Primary outcomes

  1. Quality of life questionnaire SF36

    Time frame: change over baseline and end of follow-up at 6 month

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: DOME-6

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 5, 2017
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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