Stroke Clinical Trial
Official title:
Effectiveness of Action Observation Therapy Based on Virtual Reality Technology in Motor Rehabilitation of Paretic Stroke Patients: a Randomized Clinical Trial
Rehabilitation of paretic stroke patients, aimed to improve function of the impaired upper limb, uses a wide range of intervention programs. A new rehabilitative approach, called Action Observation Therapy (AOT), based on the discovery of mirror neurons, has been used to improve motor functions of adult stroke patients and children with cerebral palsy. Recently, Virtual Reality (VR) provided the potential to increase the frequency and the effectiveness of rehabilitation treatment and offered challenging and motivating tasks. The purpose of the present project is to design a randomized, controlled, six-month follow-up trial (RCT) for evaluating whether action observation (AO) added to standard VR (AO+VR) is effective in improving upper limb function in patients with stroke, compared with a control treatment consisting in observation of naturalistic scenes (CO) devoid of action content, followed by VR training (CO+VR). The AO+VR treatment may represent an extension of the current rehabilitative interventions available for recovery after stroke and the outcome of the project could allow to include this treatment within the standard sensorimotor training or in individualized tele-rehabilitation.
Status | Recruiting |
Enrollment | 94 |
Est. completion date | September 24, 2024 |
Est. primary completion date | September 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. primarily motor symptoms with unilateral upper limb paresis (controlled via standard neurological examination); 2. residual movement ability of the paretic upper limb, controlled by Medical Research Council (MRC) index > 2 and < 4, active use of the hemiplegic limb, from minimal (mainly for assistance tasks to the preserved limb) to discrete (characterized by coarse manipulation and an inability to perform precision grip); 3. sufficient cooperation and cognitive understanding to participate in the activities, controlled by the investigator recruiting the patient. Exclusion Criteria: 1. severe cognitive impairment (score <20 on MMSE); 2. presence of severe forms of unilateral spatial neglect (Bells Test, cut-off =/> 50% ). 3. presence of severe anosognosia; 4. presence of severe language comprehension deficits assessed by clinical examination; 5. presence of severe untreated psychiatric disorders; 6. sensory impairment hindering participation and/or not compensated visual deficits of central origin; 7. drug-resistant epilepsy; 8. presence of cognitive disability (IQ < 65) controlled by administration of Wechsler Adult Intelligence Scale IV (WAIS-IV) (Wechsler, 2008). |
Country | Name | City | State |
---|---|---|---|
Italy | Istituto Clinico Quarenghi | Bergamo | Lombardia |
Italy | Centro Cardinal Ferrari, Gruppo S. Stefano Riabilitazione | Parma | Emilia-Romagna |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria di Parma | Ministry of Health, Italy |
Italy,
Buchignani B, Beani E, Pomeroy V, Iacono O, Sicola E, Perazza S, Bieber E, Feys H, Klingels K, Cioni G, Sgandurra G. Action observation training for rehabilitation in brain injuries: a systematic review and meta-analysis. BMC Neurol. 2019 Dec 27;19(1):344. doi: 10.1186/s12883-019-1533-x. — View Citation
Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31. — View Citation
Laver KE, Lange B, George S, Deutsch JE, Saposnik G, Crotty M. Virtual reality for stroke rehabilitation. Cochrane Database Syst Rev. 2017 Nov 20;11(11):CD008349. doi: 10.1002/14651858.CD008349.pub4. — View Citation
Rizzolatti G, Cattaneo L, Fabbri-Destro M, Rozzi S. Cortical mechanisms underlying the organization of goal-directed actions and mirror neuron-based action understanding. Physiol Rev. 2014 Apr;94(2):655-706. doi: 10.1152/physrev.00009.2013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of functional Magnetic Resonance Imaging (fMRI) brain activation between two time points | Functional MRI (fMRI) is used to assess plastic changes in functional brain activity. Participants are instructed to perform action observation and execution tasks consisting in observation and execution of bimanual actions inside the Magnetic Resonance scanner. Changes in Blood Oxygen Level Dependent (BOLD) signal is assessed within the main brain areas of the Mirror Neuron System, namely the ventral premotor cortex (PMv) and the inferior parietal lobule (IPL). Change of BOLD percent signal change >1% indicates increase in brain activation. Higher BOLD signal change % between time points indicate a better outcome. | Baseline (T0) and after 5 weeks of treatment (T1). | |
Primary | Change in Box and Block test (BBT) score between three time points | BBT is a timed test for assessing upper limb dexterity and motor coordination. The test consists of 150 small wooden cubes (25 mm side) contained in a wooden box. The box is split in two equal compartments. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment to the other, within 60 seconds.
The score is calculated as the number of blocks moved by the patient within 1 min, with the paretic hand. Score=0-100. Higher BBT scores between time points indicate a better outcome. |
Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2). | |
Secondary | Change in Modified Ashworth scale (MAS) score between three time points | Modified Ashworth Scale (MAS) is used to assess spasticity in patients with stroke. It is performed by extending the patients limb from a position of maximal possible flexion to maximal possible extension. Afterwards, the MAS is assessed while moving from extension to flexion.
Scoring: 0=No increase in tone. 1=Slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 2=Slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ). 3=More marked increase in tone but more marked increased in muscle tone through most limb easily flexed. 4=Considerable increase in tone, passive movement difficult. 5=Limb rigid in flexion or extension. Lower scores between time points indicate a better outcome. |
Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2). | |
Secondary | Change in Motricity Index (MI) score between three time points | The Motricity Index is used to measure strength in upper and lower extremities after stroke. Minimum score: 0. Maximum score: 100. Higher scores between time points indicate a better outcome. | Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2). | |
Secondary | Change in Rankin Scale (RS) score between three time points | The Rankin Scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. Score: 0=No symptoms at all. 1=No significant disability despite symptoms. able to carry out all usual duties and activities. 2=Slight disability, unable to carry out all previous activities, but able to look after own affairs without assistance. 3=Moderate disability; requiring some help, but able to walk without assistance. 4=Moderately severe disability; unable to walk and attend to bodily needs without assistance. 5=Severe disability, bedridden, incontinent and requiring constant nursing care and attention. Lower scores between time points indicate a better outcome. | Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2). | |
Secondary | Change in Barthel Index (BI) score between three time points | The Barthel Scale/Index is an ordinal scale used to measure performance in activities of daily living (ADL). Ten variables describing ADL and mobility are scored, a higher number being a reflection of greater ability to function independently following hospital discharge.Time taken and physical assistance required to perform each item are used in determining the assigned value of each item. Score: 0-20= "total" dependency. 21-60="severe" dependency. 61-90= "moderate" dependency. 91-99="slight" dependency.
Higher scores between time points indicate a better outcome. |
Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2). |
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