Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFondazione Don Carlo Gnocchi Onlus
About this trial
Stroke is the third most common cause of disability worldwide and leads to upper limb motor disease in more than half of people affected.
Recent data demonstrate that upper limb rehabilitation can be pursued using techniques such as the observation of action (Action Observation Therapy - AOT) or the stimulation of limb musculature using surface electrodes (Neuromuscular Electrical Stimulation - NMES).
To date, no rehabilitation studies used both the treatments (AOT-NMES) for the rehabilitation of upper limb after stroke.
The goal of this clinical trial is to study the efficacy of this combined approach (AOT-NMES) in people who developed upper limb motor impairment after stroke.
The main question this study aims to answer is if the rehabilitation performed using both action observation and neuromuscular stimulation has an higher efficacy than the use of AOT alone and higher than the observation of non-motor stimuli.
Participants will be people with upper limb impairment after stroke and will perform 15 rehabilitation sessions (5/week, 3 weeks, 60 minutes each).
Each participant will be casually included in one of following three rehabilitation groups:
* Action observation associated with neuromuscular stimulation (AOT-NMES, experimental condition): they will observe upper limb movements while their arm muscles will be stimulated. After the observation phase they will try to perform the same movements with the impaired arm. * Action observation alone (AOT): subjects will observe upper limb movements and after the observation phase then they will try to execute them with the impaired arm. * Motor-neutral observation (MNO): subjects will observe non-movement videos and after the observation phase they will try to execute upper limb movements with the impaired arm.
Each participant will be evaluated for motor function before and after rehabilitation treatment and researchers will compare the motion improvement between the groups to assess the efficacy of AOT-NMES over other treatments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age over 18 years;
Upper arm motor impairment after unilateral stroke as verified by MRI or CT;
Two weeks up to 6 months after stroke;
Grading of upper arm motor impairment>2 at Medical Research Council scale (MRC).
Disqualifiers
Neurological/orthopedic issues that would interfere with upper limb exercises;
Presence of any medical condition that represents a contraindication to Magnetic Resonance Imaging (MRI) examination or to Transcranial Magnetic Stimulation (TMS);
Presence of dermatologic issues that will interfere with neuromuscular stimulator;
Presence of electronic subcutaneous implants;
Trial design
Design model
Parallel
Treatments tested in this trial
Rehabilitation protocol: AOT+NMES
Other interventionAction observation and neuromuscular electrical stimulation followed by motor execution
Rehabilitation protocol: Action Observation Therapy (AOT)
Other interventionAction observation followed by motor execution
Observation of motor-neutral stimuli (MNO)
Other interventionMotor-neutral observation followed by motor execution
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Action Observation Therapy (AOT) associated with Neuromuscular Electrical Stimulation (NMES)Experimental treatment 1 intervention
Group B: Action Observation Therapy (AOT)Active comparator 1 intervention
Group C: Observation of motor-neutral stimuli (MNO)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in measure of upper extremity motor performance as assessed using the Fugl-Meyer Assessment of Motor Recovery after Stroke - Upper Extremity (FMA-UE) score.
The Fugl-Meyer Assessment of Motor Recovery after Stroke is one of the most widely used measures of motor impairment in post-stroke hemiplegic patients, covering 5 domains (Motor function, sensory function, balance, joint range of motion, joint pain). The assessment of upper extremity motion is performed using the Upper Extremity assessment (FMA-UE), including items scored on a 3-point ordinal scale (0: cannot perform, 1: performs partially; 2: performs fully) with total maximum score: 66 points (higher scores, best clinical profile).
Time frame
Baseline, 1 month (End of treatment), 6 months (Follow-up)Secondary outcomes
1
Changes in measure of upper limb functioning as assessed using the Action Research Arm test (ARAT)
The ARAT test assess upper limb functioning through the execution of 19 tasks, divided in 4 sub-tests (grasp, grip, pinch, and gross arm movement). Each movement is scored on a 4-point ordinal scale (0=no movement, 1=movement partially performed, 2=movement completed but takes abnormally long; 3=movement performed normally). Total possible score is 57 points, with higher scores associated to best motor functioning.
Time frame
Baseline, 1 month (End of treatment), 6 months (Follow-up)2
Changes in health and disability status as measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
WHODAS 2.0 is an instrument assessing the level of health and disability across all diseases, directly linked to the concepts of the International Classification of Functioning, Disability and Health (ICF). WHODAS 2.0 covers 6 domains (Cognition, Mobility, Self-care, Getting along, Life activities, Participation) and scores range for each item from 0 to 4 (higher scores, higher disability). The 36-items version will be administered. Summary score (possible total score: 144) and domain-specific scores (score 0-24 for each domain) will be considered as outcome measures.
Time frame
Baseline, 1 month (End of treatment), 6 months (Follow-up)3
Changes in Stroke-associated quality of life as assessed using specific subscores of the Stroke Impact Scale (SIS) 3.0
The Stroke Impact Scale 3.0 specifically measures quality of life in stroke survivors, considering multiple dimensions (strength, hand function, mobility, activities of daily living (ADL)/instrumental activities of daily living (IADL), memory, communication, emotion, social participation). Each of the 59 items can be rated on a 5-point Likert scale (from 1 to 5), with higher values corresponding to better quality of life. Each subscale of the SIS 3.0 may have a score from 0 to 100.
Time frame
Baseline, 1 month (End of treatment), 6 months (Follow-up)4
Changes in quality of life as self-rated in the EuroQol five dimensions (5D) and five levels (5L) questionnaire (EQ-5D-5L)
The EQ-5D-5L is an instrument measuring health status, yet applied in different populations and settings. The EQ-5D-5L considers five dimensions (5D: mobility, self-care, usual activities, pain/discomfort and anxiety/depression) each of them measured with a single item scored on 5 levels (5L: no problems, slight problems, moderate problems, severe problems and extreme problems). The selected level for each dimension is represented by a single digit (from 1: no problems to 5: extreme problems) and the digits of the five levels are combined in a 5-digits number describing the patient's health state, raging from 11111 (no problems in all dimensions) to 5555 (extreme problems in all dimensions).
Time frame
Baseline, 1 month (End of treatment), 6 months (Follow-up)Other outcomes
1
Technological usability of the rehabilitation system, measured using the System Usability Scale (SUS)
The System Usability Scale (SUS) is a quick and easy scale able to measure the global view of subjective usability of a tool/system. It consists of 10 items, each of them scored on a 5-points Likert scale (from "Strongly Agree" to "Strongly Disagree"). Scores are ranged from 0-100, with scores above 68 considered as usability above average.
Time frame
1 month (End of treatment)2
Treatment safety measured as total number of adverse events
Total number of adverse events eventually occurred during treatment will be collected as measure of treatment safety.
Time frame
1 month (End of treatment)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione Don Carlo Gnocchi Onlus
Lead sponsor
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Collaborator
Source ClinicalTrials.gov