So you are just asking for extreme followup with the patient doing everything and the doctor does nothing for stroke recovery. It started in 2014, what are the results?
Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial
- Jean-Michel Gracies,
- Maud PradinesEmail author,
- Mouna Ghédira,
- Catherine-Marie Loche,
- Valentina Mardale,
- Catherine Hennegrave,
- Caroline Gault-Colas,
- Etienne Audureau,
- Emilie Hutin,
- Marjolaine Baude,
- Nicolas Bayle and
- the Neurorestore Study Group
- Received: 16 October 2018
- Accepted: 14 February 2019
- Published: 12 March 2019
Abstract
Background
After discharge from hospital
following a stroke, prescriptions of community-based rehabilitation are
often downgraded to “maintenance” rehabilitation or discontinued. This
classic therapeutic behavior stems from persistent confusion between
lesion-induced plasticity, which lasts for the first 6 months
essentially, and behavior-induced plasticity, of indefinite duration,
through which intense rehabilitation might remain effective. This
prospective, randomized, multicenter, single-blind study in subjects
with chronic stroke-induced hemiparesis evaluates changes in active
function with a Guided Self-rehabilitation Contract vs conventional
therapy alone, pursued for a year.
Methods
One hundred and twenty four
adult subjects with chronic hemiparesis (> 1 year since first stroke)
will be included in six tertiary rehabilitation centers. For each
patient, two treatments will be compared over a 1-year period, preceded
and followed by an observational 6-month phase of conventional
rehabilitation. In the experimental group, the therapist will implement
the diary-based and antagonist-targeting Guided Self-rehabilitation
Contract method using two monthly home visits. The method involves: i)
prescribing a daily antagonist-targeting self-rehabilitation program,
ii) teaching the techniques involved in the program, iii) motivating and
guiding the patient over time, by requesting a diary of the work
achieved to be brought back by the patient at each visit. In the control
group, participants will benefit from conventional therapy only, as per
their physician’s prescription.
The two co-primary outcome
measures are the maximal ambulation speed barefoot over 10 m for the
lower limb, and the Modified Frenchay Scale for the upper limb.
Secondary outcome measures include total cost of care from the medical
insurance point of view, physiological cost index in the 2-min walking
test, quality of life (SF 36) and measures of the psychological impact
of the two treatment modalities. Participants will be evaluated every
6 months (D1/M6/M12/M18/M24) by a blinded investigator, the experimental
period being between M6 and M18. Each patient will be allowed to
receive any medications deemed necessary to their attending physician,
including botulinum toxin injections.
Discussion
This study will increase the
level of knowledge on the effects of Guided Self-rehabilitation
Contracts in patients with chronic stroke-induced hemiparesis.
Trial registration
ClinicalTrials.gov: NCT02202954, July 29, 2014.
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