Acute Stroke Clinical Trial
Official title:
Interdisciplinary Home Rehabilitation of Patients With Stroke. A Randomised Controlled Intervention Trial.
Objective: To evaluate the effect of interdisciplinary home rehabilitation of patients with
acute stroke. The trial seeks to evaluate:
1. Can early home rehabilitation affect the degree of independence (motor capacity,
activities of daily living and cognitive status), quality of life and the possibility
of discharge to own home?
2. Can home rehabilitation influence the length of admission at a rehabilitation centre in
the municipality, readmission to hospital, the use of healthcare services and death?
3. To what extend can home rehabilitation be implemented according to finances? Materials
and methods: Patients at the age 18 years or more admitted to the stroke unit at the
University Hospital of Gentofte. The patients were eligible when meeting the following
criteria: symptoms of stroke, need of rehabilitation tree days after admission, living
in own home in the Municipality of Gentofte, Lyngby-Taarbaek or Rudersdal and Modified
Rankin Score between 0 and 3.
The trial was conducted as a randomised controlled trial. The control group patients were
rehabilitated according to normal procedure. The intervention group patients were
rehabilitated according to normal procedure and were additionally rehabilitated at home
during admission and four weeks after discharge.
Objectives were to assess the efficacy of home-based stroke rehabilitation compared to
standard care in stroke patients using an interventional, randomised, safety/efficacy
open-label trial and parallel assignment. The setting was single-center, stroke unit at the
University Hospital of Copenhagen, Gentofte, although patients were recruited through a
collaboration of several municipalities.
Participants were eligible patients with a clinical diagnosis of stroke and focal
neurological deficits hospitalised in a stroke unit for more than three days and in need of
rehabilitation.
Interventions patients were randomised to home-based rehabilitation during hospitalization
and for up to 4 weeks after discharge to replace part of usual treatment and rehabilitation
services. Control patients received treatment and rehabilitation following usual guidelines
for the treatment of stroke patients.
Main outcome measures 90 days post-stroke, modified Rankin Scale, and motor rehabilitation,
cognitive abilities, quality of life and treatment-associated economy as secondary outcomes.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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