Ischemic StrokeNCT05283369
Changes in Motor Function and Brain Connectivity on Subacute Stroke Patients, Associated With Videogame Therapy
A study testing Videogame therapy and Conventional therapy in people with Ischemic Stroke, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Videogame therapy and Conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 2 Dec 2022to Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Visual impairments that are not corrected with glasses
- Uncompensated hearing impairment
- Patients receiving concomitant therapies
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Ana María Escalante-Gonzalbo
Mexico City, Tlalpan, CDMX, 14269
Ana María Escalante-Gonzalbo, MCSc, 5556225730, aescalan@ifc.unam.mx
About this study
Official title: Changes in Motor Function and Functional Brain Connectivity on Subacute Ischemic Stroke Patients, Associated With a New Videogame Therapy Platform
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Being tested
- Videogame therapy, Conventional therapy
- Keywords
- Hemiparesis, Subacute, virtual rehabilitation, Functional Magnetic Resonance Imaging, videogames
- Medical subject headings
- Ischemic Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videogame therapyDevice
The usual dose of conventional physical therapy, plus 300 minutes a week of in-home videogame therapy for 8 weeks.
Conventional therapyOther
The usual dose of physical and occupational therapy, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Videogame therapy | Experimental | Participants will receive conventional physical therapy, plus 300 minutes of videogame in-home therapy a week, for 8 weeks. Receives: Device: Videogame therapy |
| Conventional therapy | Active comparator | Participants will receive conventional physical therapy, plus conventional occupational therapy, as prescribed by the doctor for 8 weeks. Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Upper Extremity Test (FMUE)
The Fugl-Meyer test for Upper extremity. To assess level of motor disability
Measured: Baseline, 8 Weeks
Secondary outcomes (6)
Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test. To assess motor skill level
Measured: 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
Measured: Baseline, 8 Weeks
Barthel Index
The Barthel Index. To assess the level of independence in carrying out activities of daily living
Measured: 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
Measured: Baseline, 8 Weeks
Corsi block-tapping test
A digital implementation of the Corsi block-tapping test. To assess changes in working memory
Measured: Baseline, 8 Weeks
WAIS IV - Perceptual Reasoning section (PRI)
Perceptual Reasoning Section of the Wechsler Adult Intelligence Scale (WAIS-IV)
Measured: Baseline, 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start2 Dec 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One control group will receive conventional rehabilitation therapy, and one experimental group will receive telerehabilitation videogame therapy.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Responsible party
- Principal investigator, Ana María Escalante Gonzalbo, Universidad Nacional Autonoma de Mexico
- Investigators
- Ana María Escalante-Gonzalbo, MCompSci, Principal investigator, Universidad Nacional Autonoma de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05283369
- Sponsor's protocol ID
- 127/21
- Status last verified
- May 2024
- First submitted
- 23 Feb 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Escalante-Gonzalbo AM, Ramirez-Graullera YS, Pasantes H, Aguilar-Chale JJ, Sanchez-Castillo GI, Escutia-Macedo XA, Briseno-Soriano TM, Franco-Castro P, Estrada-Rosales AL, Vazquez-Abundes SE, Andrade-Morales D, Hernandez-Franco J, Palafox L. Safety, Feasibility, and Acceptability of a New Virtual Rehabilitation Platform: A Supervised Pilot Study. Rehabil Process Outcome. 2021 Aug 7;10:11795727211033279. doi: 10.1177/11795727211033279. eCollection 2021.
PubMed 34987304
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Motor Function and Functional Brain Connectivity on Subacute Ischemic Stroke Patients, Associated With a New Videogame Therapy Platform
- ClinicalTrials.gov ID
- NCT05283369
- Acronym / sponsor ID
- 127/21
- Conditions
- Ischemic Stroke
- Keywords
- Hemiparesis, Subacute, virtual rehabilitation, Functional Magnetic Resonance Imaging, videogames
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad Nacional Autonoma de MexicoUniversity, hospital or other
- Collaborators
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 17 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- One control group will receive conventional rehabilitation therapy, and one experimental group will receive telerehabilitation videogame therapy.
| Arm | Type | Receives |
|---|---|---|
| Videogame therapy | Experimental | Device: Videogame therapyParticipants will receive conventional physical therapy, plus 300 minutes of videogame in-home therapy a week, for 8 weeks. |
| Conventional therapy | Active comparator | Other: Conventional therapyParticipants will receive conventional physical therapy, plus conventional occupational therapy, as prescribed by the doctor for 8 weeks. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videogame therapyThe usual dose of conventional physical therapy, plus 300 minutes a week of in-home videogame therapy for 8 weeks. | Device | Videogame therapy |
| Conventional therapyThe usual dose of physical and occupational therapy, for 8 weeks. | Other | Conventional therapy |
Primary outcome
Fugl-Meyer Upper Extremity Test (FMUE)
Time frame: Baseline, 8 Weeks
The Fugl-Meyer test for Upper extremity. To assess level of motor disability
6 secondary outcomes
Wolf Motor Function Test (WMFT)
Time frame: Baseline, 8 Weeks
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
Time frame: Baseline, 8 Weeks
Barthel Index
Time frame: Baseline, 8 Weeks
Trail Making Test (TMT)
Time frame: Baseline, 8 Weeks
Corsi block-tapping test
Time frame: Baseline, 8 Weeks
WAIS IV - Perceptual Reasoning section (PRI)
Time frame: Baseline, 8 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Results publication: PubMed 34987304Escalante-Gonzalbo AM, Ramirez-Graullera YS, Pasantes H, Aguilar-Chale JJ, Sanchez-Castillo GI, Escutia-Macedo XA, Briseno-Soriano TM, Franco-Castro P, Estrada-Rosales AL, Vazquez-Abundes SE, Andrade-Morales D, Hernandez-Franco J, Palafox L. Safety, Feasibility, and Acceptability of a New Virtual Rehabilitation Platform: A Supervised Pilot Study. Rehabil Process Outcome. 2021 Aug 7;10:11795727211033279. doi: 10.1177/11795727211033279. eCollection 2021.
- Web Page of the Research and Development Laboratory of Interactive Applications for Neuro-Rehabilitation (LANR) of the UNAMLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke
RecruitingPhase 3
Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Posterior Circulation Large Vessel Occlusion Stroke
Ischemic Stroke
Not yet recruiting
Short-Term External Trigeminal Nerve Stimulation for Acute Ischemic Stroke: A Sham-Controlled Trial
Acute Ischemic Stroke
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Not yet recruitingPhase 1
ARTEMIS: UC-MSCs After Mechanical Thrombectomy for Acute Ischemic Stroke
Acute Ischemic Stroke
RecruitingPhase 2
Remote Ischaemic Conditioning for Fatigue After Stroke 2 (RICFAST 2)
Stroke, Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana María Escalante-Gonzalbo, MCompSci principal investigator
Universidad Nacional Autonoma de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videogame therapy and Conventional therapy in people with Ischemic Stroke, run by Universidad Nacional Autonoma de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana María Escalante-Gonzalbo, MCompSci ((52)5523397244, aescalan@ifc.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Upper Extremity Test (FMUE) (time frame: Baseline, 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05283369, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.