Development, Optimization, Efficiency of the Interface System of Communication and Control of the Environment (DOME-6)

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 Overview

• Status: Completed
• Conditions: Handicaps Physical
• Intervention / Treatment: Other: Help to use the Interface System of Communication and Control of the Environment

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe disabilities either of traumatic origin or of neurological origin or Patients over 55 with loss of autonomy.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life questionnaire SF36	change over baseline and end of follow-up at 6 month

Collaborators and Investigators

• Sponsor: University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Actual): April 20, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 31, 2022
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 16-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No