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Clinical Trials/NCT04622189
NCT04622189
Completed
N/A

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

University Hospital of Ferrara1 site in 1 country10 target enrollmentJune 11, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke Rehabilitation
Sponsor
University Hospital of Ferrara
Enrollment
10
Locations
1
Primary Endpoint
Motion Capture (MOCAP) recordings
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2020
End Date
December 9, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
University Hospital of Ferrara
Responsible Party
Principal Investigator
Principal Investigator

Sofia Straudi

MD, PhD

University Hospital of Ferrara

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Change in Oxford Cognitive Screen between two time points

Time Frame: Baseline and week 4

is a stroke-specific cognitive screen

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

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.

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.

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.

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.

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.

Secondary Outcomes

  • Applicability perception and satisfaction degree of the proposed treatment(At week 4)

Study Sites (1)

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