Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.

Official title

Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)

Overview

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.

Interventions

• Other Rehabilitation protocol: AOT+NMES
  Action observation and neuromuscular electrical stimulation followed by motor execution
• Other Rehabilitation protocol: Action Observation Therapy (AOT)
  Action observation followed by motor execution
• Other Observation of motor-neutral stimuli (MNO)
  Motor-neutral observation followed by motor execution

Primary outcome measures

• 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. [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]

Secondary outcome measures (12)

• Changes in measure of upper limb functioning as assessed using the Action Research Arm test (ARAT) [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in health and disability status as measured using the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in Stroke-associated quality of life as assessed using specific subscores of the Stroke Impact Scale (SIS) 3.0 [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in quality of life as self-rated in the EuroQol five dimensions (5D) and five levels (5L) questionnaire (EQ-5D-5L) [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in global cognitive functioning as assessed using the Montreal COgnitive Assessment (MoCA) score. [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in muscular electrical activity during motor acts as measured using surface Electromyography (EMGs). [Time frame: Baseline, 1 month (End of treatment)]
• Changes in the corticospinal excitability, assessed using Motor Evoked Potentials (MEPs). [Time frame: Baseline, 1 month (End of treatment)]
• Changes in motoneuron reflex excitability measured as H/M ratio amplitude. [Time frame: Baseline, 1 month (End of treatment)]
• Changes in movement parameters extracted from body kinematics. [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in muscular synergies [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in microstructural brain properties, assessed using advanced Magnetic Resonance Imaging (MRI) techniques. [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]
• Changes in brain sensory-motor networks, as investigated using functional Magnetic Resonance Imaging (fMRI). [Time frame: Baseline, 1 month (End of treatment), 6 months (Follow-up)]

Eligibility criteria

Inclusion criteria

• 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).

Exclusion criteria

• 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;
• Presence of peripheral neuropathy;
• Epilepsy;
• Pregnancy;
• Presence of severe cognitive impairment, including language comprehension detected during the neurological evaluation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• IRCCS Fondazione Don Carlo Gnocchi — Milan

Identifiers

NCT: NCT06055569 · GR-2021-12372038

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗