RESUMEN
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.
Asunto(s)
Registros Médicos , Educación del Paciente como Asunto/métodos , Rehabilitación de Accidente Cerebrovascular/métodos , Adulto , Anciano , Enfermedad Crónica , Femenino , Humanos , Persona de Mediana Edad , Paresia/etiología , Paresia/rehabilitación , Estudios Prospectivos , Calidad de Vida , Proyectos de Investigación , Método Simple Ciego , Accidente Cerebrovascular/complicacionesRESUMEN
Objectives Reliability of clinical tests to evaluate ambulation in chronic hemiparesis may vary according to the testing condition. The 10-meter ambulation test (AT10) assesses walking speed and step length over 10 m, starting and ending in seated position. In the present study, we compared the intra- and inter-reliability of AT10 in chronic hemiparesis in four different conditions: with shoes and barefoot, at free and maximal safe speed. Methods Ten patients with hemiparesis, >1 year post-stroke (age 45 ± 12, time since stroke 16 ± 9 months, mean ± SD) participated in the reliability study (registration, ID-RCB-2017-A00090-53). All patients performed the AT10 twice, one week apart, in each of the four conditions. The number of steps and time to complete the task were manually recorded by four independent raters. The main outcome measurements were the intraclass correlation coefficients (ICC), coefficients of variation (CV), and mean raw differences (DIFF) of the three parameters of AT10 (speed, step length, and cadence) in each of the four conditions. Effects of wearing shoes and speed condition were explored using ANOVA. Results Across all conditions, mean intra- and inter-rater ICCs were, respectively, 98.5 ± 0.1 and 99.9 ± 0.1% for speed, 98.3 ± 0.1 and 99.7 ± 0.2% for step length, and 96.5 ± 0.1 and 98.9 ± 0.6% for cadence. Mean intra- and inter-rater CV for speed were 0.051 ± 0.016 and 0.022 ± 0.002, respectively. Intra-rater reliability of speed assessments was higher at maximal than at free speed (ICC, CV, DIFF, p < 0.05). At free speed, intra-rater ICCs were higher barefoot than with shoes (p < 0.05). Discussion Performing the 10-meter ambulation test barefoot at maximal speed optimizes its reliability.