An interventional study of Videogame therapy and Conventional therapy in Ischemic Stroke, sponsored by Universidad Nacional Autonoma de Mexico. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Universidad Nacional Autonoma de Mexico · Not applicable, Interventional, and Treatment
The use of interactive applications associated with movement sensors has begun to spread as an option for the reinforcement of physical rehabilitation therapies in patients with acquired motor disabilities as a consequence of some neurological damage, due to their portability and the relative autonomy that they grant to the patient. However, the results of its effectiveness and impact continue to be discreet compared to traditional therapy. The present study aims to explore possible changes in motor function and in the brain's functional connectivity through resting-state functional Magnetic Resonance Imaging (rs-fMRI), for subacute ischemic stroke outpatients, associated with occupational therapy using interactive applications as a therapeutic complement, comparing with patients on conventional therapy, for which a randomized pilot study with an experimental group and a matched control group will be carried out. The intervention will consist of the application of a virtual rehabilitation program in addition to physical therapy for the experimental group, while the control group will receive conventional physical therapy. Before and after the said intervention, standardized tests will be applied to evaluate the mobility, motor function, and cognitive impairment of the participants. The results obtained will be subject to statistical analysis.
This intervention protocol aims to validate four interactive applications for telerehabilitation, as an effective therapeutic complement for the rehabilitation of patients with subacute ischemic stroke compared to conventional rehabilitation when it is administered in the subacute stage (weeks 2 to 16 after stroke).
The intervention contemplates first a phase of application of standardized tests in the rehabilitation unit of the National Institute of Neurology and Neurosurgery (INNN) in Mexico City, to determine, among other things, if the patient meets the established inclusion criteria. Patients who meet these criteria will be randomly assigned to the control or experimental group.
In the same INNN, standardized tests will be applied to record their motor and cognitive capacity at the beginning of the protocol. Patients assigned to the experimental group will be given training for using the video games at home. The trained staff of the Laboratory for Research and Development of Interactive Applications for Neurorehabilitation (LANR) will be responsible for the virtual rehabilitation program. Regarding the dose and frequency of treatment, all patients, both in the control and experimental groups, will receive the same number of physical therapy sessions in the INNN rehabilitation unit. Patients in the experimental group will commit to doing additional video game therapy, consisting of 300 minutes distributed over at least 5 days per week for 2 months (8 weeks) for a total of 40 effective days of performing the therapy. Once a week they must send a video showing how they are performing all the exercises and every 15 days they will be scheduled for a supervised virtual therapy session at the INNN, to check that the exercises are being performed correctly. Patients in the control group will receive the prescribed sessions of conventional occupational therapy for 8 weeks.
Some of the patients assigned to the control group and the experimental group will be summoned to undergo functional magnetic resonance imaging in the National Institute of Rehabilitation (INR), which will serve as a reference to assess possible changes in functional connectivity once the treatment is finished.
In the case of the experimental group, four interactive applications will be tested, each with a different sensor and virtual environment, as well as its own therapeutic objective, these applications are part of the National Autonomous University of Mexico (UNAM) virtual rehabilitation platform.
2,612 studies on the registry are indexed under Ischemic Stroke; 971 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,776 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Universidad Nacional Autonoma de Mexico is the lead sponsor of 28 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants will receive conventional physical therapy, plus 300 minutes of videogame in-home therapy a week, for 8 weeks.
Device: Videogame therapy
Participants will receive conventional physical therapy, plus conventional occupational therapy, as prescribed by the doctor for 8 weeks.
Other: Conventional therapy
The usual dose of conventional physical therapy, plus 300 minutes a week of in-home videogame therapy for 8 weeks.
The usual dose of physical and occupational therapy, for 8 weeks.
Fugl-Meyer Upper Extremity Test (FMUE)
The Fugl-Meyer test for Upper extremity. To assess level of motor disability
Time frame: Baseline, 8 Weeks
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test. To assess motor skill level
Time frame: Baseline, 8 Weeks
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
The Chedoke Arm and Hand Activity Inventory 7 tasks Test. To assess motor function
Time frame: Baseline, 8 Weeks
Barthel Index
The Barthel Index. To assess the level of independence in carrying out activities of daily living
Time frame: Baseline, 8 Weeks
Trail Making Test (TMT)
A digital implementation of the Trail Making Test. To assess Changes in cognitive function in terms of speed of executive functions and attention
Time frame: Baseline, 8 Weeks
Corsi block-tapping test
A digital implementation of the Corsi block-tapping test. To assess changes in working memory
Time frame: Baseline, 8 Weeks
WAIS IV - Perceptual Reasoning section (PRI)
Perceptual Reasoning Section of the Wechsler Adult Intelligence Scale (WAIS-IV)
Time frame: Baseline, 8 Weeks
Changes in brain functional connectivity, measured by fMRI
Changes in brain functional connectivity, measured by fMRI
Time frame: Baseline, 8 Weeks
Plan to share: No
Started Dec 2022 (actual). Primary completion is estimated for Nov 2025, 35 months after the start.
Of 572 non-industry interventional studies with no phase under Ischemic Stroke, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 35 months is above that.
Counting every sponsor, half of 653 studies reached it within 27 months; a quarter within 14 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
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Universidad Nacional Autonoma de Mexico