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Completed

NCT Number: NCT04622189

Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

The purpose of this study is to assess the changes in physiological parameters and clinical scales resulting from treatment with AOT (action observation training) in subjects with subacute stroke. Furthermore, this study assess the perception of applicability and satisfaction degree for this kind of treatments.

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Key information

Conditions

Stroke Rehabilitation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sofia Straudi

Ferrara, Emilia-Romagna, 44124, Italy

About this study

After being informed about the study, all patients give written informed consent and will undergo a 1-week screening period to determine eligibility for study entry. Patient who meet the eligibility requirements will be given clinical and instrumental assessments before the start of treatment (T0) after 3 weeks (T1), at the end of the treatment (T2) and after 6 months (T3). A training program of 4 weeks including 250 videos of every day actions has been developed. Videos includes transitive and intransitive actions. Each week has a five day program, each day is divided in three sessions, in each session there are observation and imitation and attentional questions. AOT is always performed in conjunction with the conventional rehabilitation program.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Should had experienced first ever ischemic or haemorrhagic stroke
  • Fugl-Meyer Assessment < 55
  • normal or corrected to normal visual acuity

Exclusion criteria

  • presence of severe neuropsychological disorders
  • medical conditions likely to interfere with the ability to safely complete the study protocol
  • pain in the upper limb assessed with the Visual Analogue Scale (VAS)> 7
  • intracranial metal implants
  • history of seizures or epilepsy
  • severe cardiopulmonary, renal, and hepatic diseases
  • pregnancy

Treatment and study plan

Action observation training

Device

Integration of four main tools:

  • PATIENT INTERFACE, which has been implemented to present stimuli with a user friendly interface, with personalized menu and with the possibility to manage the training program; user personal page containing user information and history of activities with daily performance are stored too.
  • MOCAP during action imitation will be recorded using MindMotion infrared camera to capture the trunk movement while an electromagnetic system (Trackstar from NDI) will be used to record fingers fine movements.
  • EEG data will be collected during video observation using an Enobio wireless system integrated with the platform.

Primary outcomes

  1. Change in Fugl-Meyer Assessment Upper Extremity between four time points

    Time frame: Baseline, week 3, week 4, after 6 months

    Scale that assess the sensorimotor impairment in individuals who have had stroke.

  2. Change in Barthel Index between four time points

    Time frame: Baseline, week 3, week 4,after 6 months

    Scale that measures disability or dependence in activities of daily living in stroke patients.

  3. Change in Box and Block Test between four time points

    Time frame: Baseline, week 3, week 4,after 6 months

    To assess unilateral gross manual dexterity

  4. Change in Modified Ashworth Scale between four time points

    Time frame: Baseline, week 3, week 4,after 6 months

    To measure spasticity. It consists of a 5-point nominal scale using subjective clinical assessments of tone ranging from 0 - 'No increases in tone' to 4 - 'Limb rigid in flexion or extension [abduction/adduction]'. An additional grade is added (1+) for the MAS to indicate resistance in the movement.

  5. Change in Visual Analogue Scale between four time points

    Time frame: Baseline , week 3, week 4,after 6 months

    Scale that consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The length of the line is 10-cm. Measurements from the starting point (left end) of the scale to the patients' marks are recorded in centimeters and are interpreted as their pain.

  6. Electroencephalography power in alpha band

    Time frame: Up to 1 month

    EEG data will be recorded to test presence of particular changes in brain activity in during AOT training. In particular plasticity and mu rhythm desynchronization will be investigated.

  7. Motion Capture (MOCAP) recordings

    Time frame: Up to 1 month

    Kinematic data of trunk and affected hand will be recorded during subject imitations and will be analysed to assess any improvements.

  8. Change in Oxford Cognitive Screen between two time points

    Time frame: Baseline and week 4

    is a stroke-specific cognitive screen

Secondary outcomes

  1. Applicability perception and satisfaction degree of the proposed treatment

    Time frame: At week 4

    self-report questionnaire using a 5 point Likert scale (1 - Strongly disagree; 5 - Strongly agree). Higher score indicates greater satisfaction with the treatment.

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Collaborators

  • Istituto Italiano di Tecnologia

Registry information

Official study title

Neuro-rehabilitation of Upper Limb Stroke Patients Through Motor Resonance and Mirror Neurons

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 9, 2020
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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