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

Completed

• Conditions: Handicaps Physical

• Registration Number: NCT03361696
• Lead Sponsor: University Hospital, Caen

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Status Verified: 2017-11
• Study First Submitted: 2017-11-29
• Study First Submitted QC: 2017-11-29
• Study First Posted: 2017-12-05
• Primary Completion: 2020-04-20
• Study Completion: 2020-12-20
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life questionnaire SF36	change over baseline and end of follow-up at 6 month

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France