Guided Self-rehabilitation Contract vs conventional therapy in chronic stroke-induced hemiparesis: NEURORESTORE, a multicenter randomized controlled trial
Autor: | Jean-Michel Gracies, Maud Pradines, Mouna Ghédira, Catherine-Marie Loche, Valentina Mardale, Catherine Hennegrave, Caroline Gault-Colas, Etienne Audureau, Emilie Hutin, Marjolaine Baude, Nicolas Bayle, the Neurorestore Study Group |
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Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
Adult
medicine.medical_specialty SF-36 Plasticity medicine.medical_treatment Medical Records lcsh:RC346-429 law.invention 03 medical and health sciences Study Protocol 0302 clinical medicine Randomized controlled trial Quality of life Patient Education as Topic law medicine Humans Single-Blind Method 030212 general & internal medicine Prospective Studies Medical prescription Stroke Motor function lcsh:Neurology. Diseases of the nervous system Aged Self-rehabilitation Rehabilitation business.industry Stroke Rehabilitation Chronic hemiparesis General Medicine Middle Aged medicine.disease Paresis Hemiparesis Research Design Chronic Disease Physical therapy Quality of Life Observational study Female Neurology (clinical) medicine.symptom business 030217 neurology & neurosurgery |
Zdroj: | BMC Neurology, Vol 19, Iss 1, Pp 1-11 (2019) BMC Neurology |
ISSN: | 1471-2377 |
Popis: | 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. 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. This study will increase the level of knowledge on the effects of Guided Self-rehabilitation Contracts in patients with chronic stroke-induced hemiparesis. ClinicalTrials.gov: NCT02202954 , July 29, 2014. |
Databáze: | OpenAIRE |
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