Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07793682 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Early Neuropsychological Rehabilitation and Family Psychoeducation After Ischemic Stroke

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Althaia Xarxa Assistencial Universitària de Manresa

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modifiedv2 Show 6 more changesShow less
    • Sponsor changed: Jordi Sanchez Monteagudo to Althaia Xarxa Assistencial Universitària de Manresa
    • Study completion pushed from Mar 20, 2027 to Jul 27, 2027
    • Interventions modified
    • Eligibility criteria expanded, about 100 words
    • Secondary endpoints revised (8)
    • Study description shortened, about 73 words
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Cognitive impairment and reduced quality of life are frequent consequences of ischemic stroke and can also affect family caregivers, who often assume caregiving responsibilities with limited preparation. Evidence regarding rehabilitation interventions initiated during the early poststroke period remains limited. This randomized clinical trial evaluates two independent interventions initiated after baseline assessment and randomization, approximately 20 days after the index stroke: a structured computerized neuropsychological rehabilitation program for the patient and a structured psychoeducational program for the primary family caregiver. A 2×2 factorial design allows the main effect of each intervention to be estimated within a single sample and permits an exploratory assessment of their interaction. The primary outcome is quality of life at 3 months after stroke, measured using the CAVIDACE total direct score and completed by a family informant. Secondary outcomes include cognitive performance, functional status, mood, and caregiver burden. Molecular biomarkers and acute structural neuroimaging variables are examined as exploratory outcomes.
Trial Details
NCT Number NCT07793682
Lead Sponsor Althaia Xarxa Assistencial Universitària de Manresa
Collaborators: University of Vic - Central University of Catalonia
Conditions
(from sponsor)
Ischemic Stroke, Cognitive Impairment, Quality of Life, Caregiver Burden
Related terms Caregiver Burden, Cognitive Dysfunction, Ischemic Stroke
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov