Early intensive neurorehabilitation in patients with Disorders of Consciousness: Treatment and Outcomes Registry (DOCTOR)
Recruiting
- Conditions
- Acquired brain injury
- Registration Number
- NL-OMON23779
- Lead Sponsor
- ibra, rehabilitation & audiology
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
•Age16 years or older.
•DOC (UWS or MCS) lasting > 2 weeks at admission and < 6 months
•First-time newly acquired non-progressive brain injury of any aetiology confirmed by neurological and /or neuroimaging data
•Weaned from ventilator
•Medically stable, as judged by the treating rehabilitation physician.
Exclusion Criteria
•Coma
•Any pre-existent progressive or non-progressive brain injury
•Uncontrollable epilepsy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate and timing of recovery of consciousness, using the Coma Recovery Scale-Revised. Furthermore the number and type of medical complications, including pain and mortality, patient’s level of disability, including the level of motor, cognitive, behavioural and emotional functioning, participation, and quality of life.
- Secondary Outcome Measures
Name Time Method Secondary outcomes include self-efficacy of caregivers and caregivers’ strain and cost-effectiveness of the program.