Improved Recovery of Walking in Acquired Muscle Weakness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
clinical diagnosis of tetra/paraparesis of peripheral origin as disclosed by ENG/EMG examination;
be independent before the episode of critical illness
Disqualifiers
history of previous comorbidity for ICU-AW;
previous known chronic polyneuropathy;
severe coagulopathy;
severe disorder of consciousness;
Trial design
Design model
Parallel
Treatments tested in this trial
Rehabilitation protocol: FES
Other interventionSubjects diagnosed with CIP will follow the FES-based rehabilitation protocol
Rehabilitation protocol without FES
Other interventionSubjects belonging to the control group will follow the rehabilitation protocol without FES
Rehabilitation protocol: FES
Other interventionSubjects diagnosed with CIM will follow the FES-based rehabilitation protocol
Treatment groups
72 Participants
are divided into 4 treatment groupsGroup A: CIP-FESExperimental treatment 1 intervention
Group B: CIM-FESExperimental treatment 1 intervention
Group C: CIP-CONActive comparator 1 intervention
Group D: CIM-CONActive comparator 1 intervention
Trial outcomes
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).
Time frame
Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)Secondary outcomes
1
Walking velocity on 10 meters walking test
Walking speed is measured by the timed 10-meter Walk Test (10MWT). Participants walk a distance of 10 meters at their usual speed with their usual walking aids. Participants are timed while walking 10 meters from a starting point to an end point. Time taken from meter 2 to meter 8. Two repetitions are completed and the average time is used to calculate walking speed in metres/second. During the test, EMG and kinematic data will be recorded using EMG-sensors and three IMUs, two placed on the feet and one on the lower back.
Time frame
Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)2
Modified Barthel Index
Measurement instrument, based on an ordinal scale, commonly used to assess daily life activities. The total score ranges from 0 (total dependency) to 100 (full autonomy).
Time frame
Baseline (T0), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)3
Instrumented Six Minute Walk Test
Walking capacity is measured with the Participant timed while walking a 30 meter track constantly for 6 minutes. Participants are permitted to use their walking aids if necessary, and Patients will wear an IMU. The distance walked in 6 minutes is recorded and reported in meters.
Time frame
Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)4
Timed Up and Go Test
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. Patient are timed while standing up from a chair walking 3 meters, turning around, walking 3 meters and sitting down again. The patient sits in the chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Timing begins at the instruction "go" and stops when the patient is seated.
Time frame
Baseline (T0), 3-week from T0 (T1), after 15 rehabilitation sessions (each session is 60 minutes, T2), 3-month follow-up (T3)Other outcomes
1
Gender data
Gender of enrolled subject
Time frame
Baseline (T0)2
Age data
Age of enrolled subject
Time frame
Baseline (T0)3
Scholarity data
Scholarity of enrolled subject
Time frame
Baseline (T0)Sponsors and contacts
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Source ClinicalTrials.gov