Actively Recruiting
Efficacy of a Rehabilitation Treatment Using Observation Therapy Enhanced by Muscle Synergy-Derived Electrical Stimulation in Post-stroke Patients (OTHELLO)
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-11-13
60
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
I
Istituto di Neuroscienze Consiglio Nazionale delle Ricerche
Collaborating Sponsor
AI-Summary
What this Trial Is About
Stroke is a leading cause of disability worldwide, often resulting in upper limb motor problems for many affected individuals. Researchers are studying a combined rehabilitation approach using action observation therapy (AOT) and neuromuscular electrical stimulation (NMES) to improve upper limb movement after stroke. This trial aims to determine if combining these treatments offers better motor recovery than AOT alone or observing non-motor videos. Participants will be randomly assigned to one of three groups for 15 rehabilitation sessions over three weeks, with five sessions per week lasting 60 minutes each. The groups include action observation combined with muscle stimulation (AOT-NMES), action observation alone (AOT), and observation of motor-neutral videos (MNO). After watching the videos, participants will attempt to perform the observed movements with the impaired arm. Throughout the study, participants will be evaluated before treatment, at the end of the three weeks, and at six months follow-up. Assessments include motor performance using the Fugl-Meyer Assessment of Motor Recovery and several secondary measures covering arm function, disability, quality of life, cognitive function, muscle activity, brain excitability, movement analysis, and brain imaging. These evaluations help researchers understand the effectiveness of the combined therapy over time.
CONDITIONS
Brief Title
Efficacy of Rehabilitation Using Action Observation and Muscle Stimulation in Post-stroke Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Upper arm motor impairment after unilateral stroke confirmed by MRI or CT
- Stroke occurred between two weeks and six months prior
- Upper arm motor impairment greater than 2 on Medical Research Council scale
You will not qualify if you...
- Neurological or orthopedic issues interfering with upper limb exercises
- Medical conditions contraindicating MRI or Transcranial Magnetic Stimulation
- Skin conditions interfering with neuromuscular stimulation
- Presence of electronic subcutaneous implants
- Peripheral neuropathy
- Epilepsy
- Pregnancy
- Severe cognitive impairment or language comprehension issues detected during neurological evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 weeks
Participants receive rehabilitation therapy involving action observation and muscle stimulation or control interventions for motor recovery after stroke.
5 consecutive days per week, 60-minute sessions
Duration - Up to 6 months after treatment
Participants are monitored to assess long-term changes in motor performance and brain function after rehabilitation treatment.
Visits at 1 month (end of treatment) and 6 months (follow-up)
Trial Site Locations
Total: 1 location
1
IRCCS Fondazione Don Carlo Gnocchi
Milan, Italia, Italy, 20148
Actively Recruiting
Research Team
M
Monia Cabinio, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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