Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06055569

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

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-11-13

60

Participants Needed

1

Research Sites

125 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 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Upper arm motor impairment after unilateral stroke confirmed by MRI or CT
  • Stroke occurred between 2 weeks and 6 months before enrollment
  • Upper arm motor impairment greater than 2 on the Medical Research Council scale
Not Eligible

You will not qualify if you...

  • Neurological or orthopedic conditions interfering with upper limb exercises
  • Medical conditions preventing MRI or Transcranial Magnetic Stimulation exams
  • Skin problems preventing use of neuromuscular stimulation
  • Presence of implanted electronic devices under the skin
  • Peripheral neuropathy
  • Epilepsy
  • Pregnancy
  • Severe cognitive or language comprehension impairments detected during neurological evaluation

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italia, Italy, 20148

Actively Recruiting

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Research Team

M

Monia Cabinio, Ph.D.

CONTACT

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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