Effectiveness of AOT Based on Virtual Reality in Stroke Rehabilitation. (NCT05163210) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of AOT Based on Virtual Reality in Stroke Rehabilitation.
Italy48 participantsStarted 2021-09-24
Plain-language summary
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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. primarily motor symptoms with unilateral upper limb paresis (controlled via standard neurological examination);
✓. 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);
✓. sufficient cooperation and cognitive understanding to participate in the activities, controlled by the investigator recruiting the patient.
Exclusion criteria
✕. severe cognitive impairment (score \<20 on MMSE);
✕. presence of severe forms of unilateral spatial neglect (Bells Test, cut-off =/\> 50% ).
✕. presence of severe anosognosia;
✕. presence of severe language comprehension deficits assessed by clinical examination;
✕. presence of severe untreated psychiatric disorders;
What they're measuring
1
Change in Box and Block test (BBT) score between three time points
Timeframe: Baseline (T0), after 5 weeks of treatment (T1) and after 6 months (T2).