Improved Recovery of Walking in Acquired Muscle Weakness

NCT06786390 | Recruiting DMC

• 1 other identifier: Re-Walk-Easy-SC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness Myopathy; Critical Illness Polyneuropathy

Keywords

Functional Electrical Stimulation; Acquired Muscle Weakness; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Medical Research Council - Sum Score (MRC-SS)

  The scale measures six bilateral muscle groups (wrist flexion, elbow flexion, shoulder abduction, ankle dorsiflexion, knee extension and hip flexion) with a maximum score of 60 points (normality) and a minimum score of 0 points (No muscle contraction visible or palpable).

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

Secondary Outcomes (12)

• Walking velocity on 10 meters walking test

  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

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

• Instrumented Six Minute Walk Test

  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

  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

  Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)

Other Outcomes (3)

• Gender data

  Baseline (T0)

• Age data

  Baseline (T0)

• Scholarity data

  Baseline (T0)

Study Arms (4)

CIP-FES

EXPERIMENTAL

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency, Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks, will be performed, with FES applied in parallel. Two approaches will be used: (i) assistive stimulation for passive patients with poor muscle strength, and (ii) proportional active stimulation for subjects with residual muscle strength.

Other: Rehabilitation protocol: FES

CIM-FES

EXPERIMENTAL

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency, Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks, will be performed, with FES applied in parallel. Two approaches will be used: (i) assistive stimulation for passive patients with poor muscle strength, and (ii) proportional active stimulation for subjects with residual muscle strength.

Other: Rehabilitation protocol: FES

CIP-CON

ACTIVE COMPARATOR

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency, Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks (e.g., overground straight walking), will be performed without FES. The electrical stimulator will be positioned, and the amplitude will be set to zero

Other: Rehabilitation protocol without FES

CIM-CON

ACTIVE COMPARATOR

Each subject will receive 15 individual rehabilitation sessions, each lasting 60 minutes, conducted 3 to 5 times per week over a period of 5 to 3 weeks, depending on the weekly frequency, Intentional, repetitive movements, such as lower limb movements within goal-oriented mobility tasks (e.g., overground straight walking), will be performed without FES. The electrical stimulator will be positioned, and the amplitude will be set to zero

Other: Rehabilitation protocol without FES

Interventions

Rehabilitation protocol: FES OTHER

Subjects diagnosed with CIP will follow the FES-based rehabilitation protocol

CIP-FES

Rehabilitation protocol without FES OTHER

Subjects belonging to the control group will follow the rehabilitation protocol without FES

CIM-CON; CIP-CON

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• history of previous comorbidity for ICU-AW;
• previous known chronic polyneuropathy;
• severe coagulopathy;
• severe disorder of consciousness;
• contraindications to Electrical Stimulation application
• Prosthetic implants
• musculoskeletal, neurological, cardiovascular and pulmonary disorders that may alter the gait

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi Onlus

Milan, 20148, Italy

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Garcia-Perez-de-Sevilla G, Sanchez-Pinto Pinto B. Effectiveness of physical exercise and neuromuscular electrical stimulation interventions for preventing and treating intensive care unit-acquired weakness: A systematic review of randomized controlled trials. Intensive Crit Care Nurs. 2023 Feb;74:103333. doi: 10.1016/j.iccn.2022.103333. Epub 2022 Oct 22.

  PMID: 36283894 BACKGROUND

• Wang W, Xu C, Ma X, Zhang X, Xie P. Intensive Care Unit-Acquired Weakness: A Review of Recent Progress With a Look Toward the Future. Front Med (Lausanne). 2020 Nov 23;7:559789. doi: 10.3389/fmed.2020.559789. eCollection 2020.

  PMID: 33330523 BACKGROUND

• Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.

  PMID: 21939902 BACKGROUND

MeSH Terms

Conditions

Polyneuropathies

Interventions

proto-oncogene protein c-fes-fps

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Tiziana Lencioni

CONTACT

00390240308547; tlencioni@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Researchers devoted to data collection and Patients will be masked to the allocated treatment. On subjects belonging to control group, the stimulation device will be placed normally and the stimulation intensity will be set at 0.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A double-blind longitudinal RCT will be performed. The subjects enrolled will be divided in two groups on the basis of their diagnosis, CIP/CIM. Subsequently subjects will be randomly assigned either to the experimental group (FES), or to the control group (CON).

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 22, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Preliminary data will be available at the end of the study
• Access Criteria: at request to the Principal investigator

Locations

IT (1)