Tests arm rehabilitation combining movement observation and muscle stimulation after stroke
Tests combined watching movement and muscle stimulation in adults with arm weakness after stroke.
Plain-language title generated from the registry record
Registry title: Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.
Key facts
- Where
- Milan, ItalySee the site
Where in Italy
- IRCCS Fondazione Don Carlo GnocchiMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Don Carlo Gnocchi ETS
- Trial code
- NCT06055569
- Record updated
- 13 November 2024
- Original description
Stroke is the third most common cause of disability worldwide and leads to upper limb motor disease in more than half of people affected.Read full original descriptionShow less
Efficacy of a Rehabilitation Treatment Using Observation THerapy Enhanced by MuscLe Synergy-derived ELectrical StimulatiOn in Post-stroke Patients (OTHELLO)
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.
Inclusion: 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: Presence of electronic subcutaneous implants; Presence of any medical condition that represents a contraindication to Magnetic Resonance Imaging (MRI) examination or to Transcranial Magnetic Stimulation (TMS); Epilepsy; Presence of severe cognitive impairment, including language comprehension detected during the neurological evaluation; Neurological/orthopedic issues that would interfere with upper limb exercises; Presence of dermatologic issues that will interfere with neuromuscular stimulator; Presence of peripheral neuropathy; Pregnancy.