Improved Recovery of Walking in Acquired Muscle Weakness

Официальное название

Regaining Walking Ability Easier and Better in Critical Illness Polyneuropathy and Myopathy

Обзор

The aim of Re-Walk-Easy is to evaluate the effects of rehabilitation based on electrical stimulation on the motor performance of critically ill patients. The study will also investigate the pathophysiology of the two forms-the myopathic-predominant and the polyneuropathic-predominant variants-by examining the longitudinal progression of CIP and CIM and determining which form benefits more from electrical stimulation as a rehabilitative approach.

Подробное описание

Although rehabilitation is often recommended to patients with Intensive Care Unit Acquired Weakness (ICU-AW) to counteract the induced muscle weakness, systematic reviews failed to determine its efficacy. Neuro Muscular Electrical Stimulation (NMES) is part of clinical practice in ICU-AW however its effects are still under debate. The investigators hypothesize that this uncertainty stems from the lack of distinction between the two forms of the condition-Critical Illness Polyneuropathy (CIP) and Critical Illness Myopathy (CIM)-which have distinct pathological features and disease trajectories. In addition, the investigators hypothesize that motivating patients by requiring voluntary muscle activation during the Electrical Stimulation (i.e. Functional Electrical Stimulation - FES) will enhance rehabilitation.

The study will test the following hypothesis through a longitudinal clinical trial aimed at determining:

1. which form will benefit the most from FES based-rehabilitation, 2. the biomarkers of walking recovery in ICU-AW.

Вмешательства

• Другое Rehabilitation protocol: FES
  Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol
• Другое Rehabilitation protocol without FES
  Subjects belonging to the control group will follow the rehabilitation protocol without FES
• Другое Rehabilitation protocol: FES
  Subjects diagnosed with CIM will follow the FES-based rehabilitation protocol

Первичные конечные точки

• Medical Research Council - Sum Score (MRC-SS) [Срок оценки: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]

Вторичные конечные точки (12)

• Walking velocity on 10 meters walking test [Срок оценки: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Modified Barthel Index [Срок оценки: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Instrumented Six Minute Walk Test [Срок оценки: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Timed Up and Go Test [Срок оценки: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Euro Quality of Life-5 -dimension Questionnaire [Срок оценки: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Client Satisfaction Questionnaire - CSQ [Срок оценки: After 15 rehabilitation sessions (each session is 60 minutes, T2)]
• Needle Electromyography-based parameters [Срок оценки: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Electroneurography (ENG) and Nerve Conduction Studies [Срок оценки: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Electroneurography (ENG) and Nerve Conduction Studies [Срок оценки: Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Postural capabilities will be evaluated based on body kinetics [Срок оценки: Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)]
• Fall diary [Срок оценки: From baseline (T0) to 3-month follow-up (T3)]
• Report of adverse events [Срок оценки: From baseline (T0) to post-treatment evaluation, after the 15 rehabilitation sessions (each session is 60 minutes, T2)]

Критерии участия

Critical Illness Patient Inclusion Criteria:

• clinical diagnosis of tetra/paraparesis of peripheral origin as disclosed by ENG/EMG examination;
• be independent before the episode of critical illness

Critical Illness Patient Exclusion Criteria:

• history of previous comorbidity for ICU-AW;
• previous known chronic polyneuropathy;
• severe coagulopathy;
• severe disorder of consciousness;
• contraindications to Electrical Stimulation application

Healthy Subjects Exclusion Criteria:

• Prosthetic implants
• musculoskeletal, neurological, cardiovascular and pulmonary disorders that may alter the gait

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• IRCCS Fondazione Don Carlo Gnocchi Onlus — Milan

Публикации

• Van Lancker K, Bretz F, Dukes O. Covariate adjustment in randomized controlled trials: General concepts and practical considerations. Clin Trials. 2024 Aug;21(4):399-411. doi: 10.1177/17407745241251568. Epub 2024 Jun 2. PMID 38825841
• Dobkin BH. Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):197-206. doi: 10.1177/1545968309331863. PMID 19240197
• Gordon T. Electrical Stimulation to Enhance Axon Regeneration After Peripheral Nerve Injuries in Animal Models and Humans. Neurotherapeutics. 2016 Apr;13(2):295-310. doi: 10.1007/s13311-015-0415-1. PMID 26754579
• Jonsdottir J, Thorsen R, Aprile I, Galeri S, Spannocchi G, Beghi E, Bianchi E, Montesano A, Ferrarin M. Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach. PLoS One. 2017 Dec 4;12(12):e0188642. doi: 10.1371/journal.pone.0188642. eCollection 2017. PMID 29200424
• Perini G, Bertoni R, Thorsen R, Carpinella I, Lencioni T, Ferrarin M, Jonsdottir J. Sequentially applied myoelectrically controlled FES in a task-oriented approach and robotic therapy for the recovery of upper limb in post-stroke patients: A randomized controlled pilot study. Technol Health Care. 2021;29(3):419-429. doi: 10.3233/THC-202371. PMID 33386831
• Connolly B, O'Neill B, Salisbury L, McDowell K, Blackwood B; Enhanced Recovery After Critical Illness Programme Group. Physical rehabilitation interventions for adult patients with critical illness across the continuum of recovery: an overview of systematic reviews protocol. Syst Rev. 2015 Sep 29;4:130. doi: 10.1186/s13643-015-0119-y. PMID 26419458
• Mehrholz J, Pohl M, Kugler J, Burridge J, Muckel S, Elsner B. Physical rehabilitation for critical illness myopathy and neuropathy: an abridged version of Cochrane Systematic Review. Eur J Phys Rehabil Med. 2015 Oct;51(5):655-61. Epub 2015 Jul 9. PMID 26158919
• Liu M, Luo J, Zhou J, Zhu X. Intervention effect of neuromuscular electrical stimulation on ICU acquired weakness: A meta-analysis. Int J Nurs Sci. 2020 Mar 10;7(2):228-237. doi: 10.1016/j.ijnss.2020.03.002. eCollection 2020 Apr 10. PMID 32685621

Идентификаторы

NCT: NCT06786390 · Re-Walk-Easy-SC

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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