Stroke
Conditions
Brief summary
Many studies have demonstrated the usefulness of repetitive task practice by using robotic devices, including Lokomat, for the treatment of lower limb paresis. Virtual reality (VR) has proved to be a valuable tool to improve neurorehabilitation training. Our pilot randomized clinical trial aimed at evaluating the correlation between the modifications of brain oscillations during a VR neurorehabilitative training of gait and the motor function recovery in patients with chronic stroke. Twenty-four patients suffering from a first unilateral ischemic stroke in the chronic phase were randomized into two groups. One group performed 40 sessions of Lokomat with VR (RAGT+VR) whereas the other group underwent Lokomat without VR (RAGT-VR). Outcomes (clinical, kinematic, and event-related synchronization, ERS, and desynchronization, ERD, at the EEG) were measured before and after the robotic intervention. The robotic-based rehabilitation combined with VR could be associated with improvements in several measurements of lower limb function, gait, and balance in patient with chronic hemiparesis. Moreover, ERS/ERD analysis can be proposed as a tool to monitor motor performance and to develop non-invasive brain-computer interfaces controlling robotic devices.
Interventions
DEVICELokomat
Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The RAGTand VR group received a visual feedback showing a VR run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. Each avatar's leg movement corresponded to that performed by the patient. On the other hand, the RAGT without VR group was not provided an avatar, and a smile indicating the goodness of each leg movement. The biofeedback of the Lokomat gait orthosis is based on the interaction torques between the participant and the orthosis
Sponsors
IRCCS Centro Neurolesi Bonino Pulejo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥55 years * A first-ever ischemic supra-tentorial stroke (confirmed by MRI scan) at least 6 months before their enrollment; * An unilateral hemiparesis, with a Muscle Research Council -MCR- score ≤3 * Ability to follow verbal instructions, with a Mini-Mental State Examination (MMSE) \>24 * A mild to moderate spasticity according to a Modified Ashworth Scale (MAS) ≤2 * No severe bone or joint disease * No history of concomitant neurodegenerative diseases or brain surgery.
Exclusion criteria
* Severe cognitive and behavioral impairments * Severe osteoporosis and previous bone fractures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gait evaluated by Rivermead Mobility Index (RMI) | Six months |
Secondary
| Measure | Time frame |
|---|---|
| Spasticity evaluated by Modified Ashworth Scale (MAS) | Six months |
Outcome results
None listed