- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05283369
Changes in Motor Function and Brain Connectivity on Subacute Stroke Patients, Associated With Videogame Therapy
Changes in Motor Function and Functional Brain Connectivity on Subacute Ischemic Stroke Patients, Associated With a New Videogame Therapy Platform
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ana María Escalante-Gonzalbo, MCompSci
- Phone Number: (52)5523397244
- Email: aescalan@ifc.unam.mx
Study Contact Backup
- Name: Yoás S Ramírez-Graullera, MCompSci
- Phone Number: (52)5527409802
- Email: ygraullera@ifc.unam.mx
Study Locations
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Tlalpan, CDMX
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Mexico City, Tlalpan, CDMX, Mexico, 14269
- Recruiting
- Ana María Escalante-Gonzalbo
-
Contact:
- Ana Maria Escalante-Gonzalbo, MCSc
- Phone Number: 5556225730
- Email: aescalan@ifc.unam.mx
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Upper extremity hemiparesis caused by ischemic stroke on its dominant side or not
- In the subacute phase. From 2 to 16 weeks of ischemic stroke event
- Fugl-Meyer Upper Extremity > 15
- No previous stroke
Exclusion Criteria:
- Token Test < 17. Inability to understand verbal instructions
- Instability of the shoulder, elbow, or wrist joints
- Severe concomitant medical problems such as congestive heart failure or seizures
- Anosognosia
- Severe aphasia
- Hemispatial neglect
- Visual impairments that are not corrected with glasses
- Uncompensated hearing impairment
- Patients receiving concomitant therapies
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Videogame therapy
Participants will receive conventional physical therapy, plus 300 minutes of videogame in-home therapy a week, for 8 weeks.
|
The usual dose of conventional physical therapy, plus 300 minutes a week of in-home videogame therapy for 8 weeks.
|
Active Comparator: Conventional therapy
Participants will receive conventional physical therapy, plus conventional occupational therapy, as prescribed by the doctor for 8 weeks.
|
The usual dose of physical and occupational therapy, for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fugl-Meyer Upper Extremity Test (FMUE)
Time Frame: Baseline, 8 Weeks
|
The Fugl-Meyer test for Upper extremity.
To assess level of motor disability
|
Baseline, 8 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wolf Motor Function Test (WMFT)
Time Frame: Baseline, 8 Weeks
|
The Wolf Motor Function Test.
To assess motor skill level
|
Baseline, 8 Weeks
|
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
Time Frame: Baseline, 8 Weeks
|
The Chedoke Arm and Hand Activity Inventory 7 tasks Test.
To assess motor function
|
Baseline, 8 Weeks
|
Barthel Index
Time Frame: Baseline, 8 Weeks
|
The Barthel Index.
To assess the level of independence in carrying out activities of daily living
|
Baseline, 8 Weeks
|
Trail Making Test (TMT)
Time Frame: Baseline, 8 Weeks
|
A digital implementation of the Trail Making Test.
To assess Changes in cognitive function in terms of speed of executive functions and attention
|
Baseline, 8 Weeks
|
Corsi block-tapping test
Time Frame: Baseline, 8 Weeks
|
A digital implementation of the Corsi block-tapping test.
To assess changes in working memory
|
Baseline, 8 Weeks
|
WAIS IV - Perceptual Reasoning section (PRI)
Time Frame: Baseline, 8 Weeks
|
Perceptual Reasoning Section of the Wechsler Adult Intelligence Scale (WAIS-IV)
|
Baseline, 8 Weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in brain functional connectivity, measured by fMRI
Time Frame: Baseline, 8 Weeks
|
Changes in brain functional connectivity, measured by fMRI
|
Baseline, 8 Weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ana María Escalante-Gonzalbo, MCompSci, Universidad Nacional Autonoma de Mexico
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 127/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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