Action Observation Training for Upper Limb Rehabilitation in Stroke Patients

Stroke Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622189
• Other study ID #: Brain_AOT_stroke
• Status: Completed
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: December 9, 2021

Study information

• Verified date: May 2022
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 9, 2021
• Est. primary completion date: December 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

Device:
• Action observation training
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.

Locations

Country	Name	City	State
Italy	Sofia Straudi	Ferrara	Emilia Romagna

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital of Ferrara	Istituto Italiano di Tecnologia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl-Meyer Assessment Upper Extremity between four time points	Scale that assess the sensorimotor impairment in individuals who have had stroke.	Baseline, week 3, week 4, after 6 months
Primary	Change in Barthel Index between four time points	Scale that measures disability or dependence in activities of daily living in stroke patients.	Baseline, week 3, week 4,after 6 months
Primary	Change in Box and Block Test between four time points	To assess unilateral gross manual dexterity	Baseline, week 3, week 4,after 6 months
Primary	Change in Modified Ashworth Scale between four time points	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.	Baseline, week 3, week 4,after 6 months
Primary	Change in Visual Analogue Scale between four time points	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.	Baseline , week 3, week 4,after 6 months
Primary	Electroencephalography power in alpha band	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.	Up to 1 month
Primary	Motion Capture (MOCAP) recordings	Kinematic data of trunk and affected hand will be recorded during subject imitations and will be analysed to assess any improvements.	Up to 1 month
Primary	Change in Oxford Cognitive Screen between two time points	is a stroke-specific cognitive screen	Baseline and week 4
Secondary	Applicability perception and satisfaction degree of the proposed treatment	self-report questionnaire using a 5 point Likert scale (1 - Strongly disagree; 5 - Strongly agree). Higher score indicates greater satisfaction with the treatment.	At week 4