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Changes in Motor Function and Brain Connectivity on Subacute Stroke Patients, Associated With Videogame Therapy

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Videogame therapy
Conventional therapy
Sponsored by
Universidad Nacional Autonoma de Mexico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Hemiparesis, Subacute, virtual rehabilitation, Functional Magnetic Resonance Imaging, videogames

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ana María Escalante-GonzalboRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Videogame therapy

Conventional therapy

Arm Description

Participants will receive conventional physical therapy, plus 300 minutes of videogame in-home therapy a week, for 8 weeks.

Participants will receive conventional physical therapy, plus conventional occupational therapy, as prescribed by the doctor for 8 weeks.

Outcomes

Primary Outcome Measures

Fugl-Meyer Upper Extremity Test (FMUE)
The Fugl-Meyer test for Upper extremity. To assess level of motor disability

Secondary Outcome Measures

Wolf Motor Function Test (WMFT)
The Wolf Motor Function Test. To assess motor skill level
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
The Chedoke Arm and Hand Activity Inventory 7 tasks Test. To assess motor function
Barthel Index
The Barthel Index. To assess the level of independence in carrying out activities of daily living
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
Corsi block-tapping test
A digital implementation of the Corsi block-tapping test. To assess changes in working memory
WAIS IV - Perceptual Reasoning section (PRI)
Perceptual Reasoning Section of the Wechsler Adult Intelligence Scale (WAIS-IV)

Full Information

First Posted
February 23, 2022
Last Updated
January 3, 2023
Sponsor
Universidad Nacional Autonoma de Mexico
Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
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1. Study Identification

Unique Protocol Identification Number
NCT05283369
Brief Title
Changes in Motor Function and Brain Connectivity on Subacute Stroke Patients, Associated With Videogame Therapy
Official Title
Changes in Motor Function and Functional Brain Connectivity on Subacute Ischemic Stroke Patients, Associated With a New Videogame Therapy Platform
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Autonoma de Mexico
Collaborators
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Hemiparesis, Subacute, virtual rehabilitation, Functional Magnetic Resonance Imaging, videogames

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One control group will receive conventional rehabilitation therapy, and one experimental group will receive telerehabilitation videogame therapy.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Videogame therapy
Arm Type
Experimental
Arm Description
Participants will receive conventional physical therapy, plus 300 minutes of videogame in-home therapy a week, for 8 weeks.
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
Participants will receive conventional physical therapy, plus conventional occupational therapy, as prescribed by the doctor for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Videogame therapy
Intervention Description
The usual dose of conventional physical therapy, plus 300 minutes a week of in-home videogame therapy for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Conventional therapy
Intervention Description
The usual dose of physical and occupational therapy, for 8 weeks.
Primary Outcome Measure Information:
Title
Fugl-Meyer Upper Extremity Test (FMUE)
Description
The Fugl-Meyer test for Upper extremity. To assess level of motor disability
Time Frame
Baseline, 8 Weeks
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test (WMFT)
Description
The Wolf Motor Function Test. To assess motor skill level
Time Frame
Baseline, 8 Weeks
Title
Chedoke Arm and Hand Activity Inventory (CAHAI-7)
Description
The Chedoke Arm and Hand Activity Inventory 7 tasks Test. To assess motor function
Time Frame
Baseline, 8 Weeks
Title
Barthel Index
Description
The Barthel Index. To assess the level of independence in carrying out activities of daily living
Time Frame
Baseline, 8 Weeks
Title
Trail Making Test (TMT)
Description
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
Title
Corsi block-tapping test
Description
A digital implementation of the Corsi block-tapping test. To assess changes in working memory
Time Frame
Baseline, 8 Weeks
Title
WAIS IV - Perceptual Reasoning section (PRI)
Description
Perceptual Reasoning Section of the Wechsler Adult Intelligence Scale (WAIS-IV)
Time Frame
Baseline, 8 Weeks
Other Pre-specified Outcome Measures:
Title
Changes in brain functional connectivity, measured by fMRI
Description
Changes in brain functional connectivity, measured by fMRI
Time Frame
Baseline, 8 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana María Escalante-Gonzalbo, MCompSci
Phone
(52)5523397244
Email
aescalan@ifc.unam.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Yoás S Ramírez-Graullera, MCompSci
Phone
(52)5527409802
Email
ygraullera@ifc.unam.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana María Escalante-Gonzalbo, MCompSci
Organizational Affiliation
Universidad Nacional Autonoma de Mexico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ana María Escalante-Gonzalbo
City
Mexico City
State/Province
Tlalpan, CDMX
ZIP/Postal Code
14269
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana María Escalante-Gonzalbo, MCSc
Phone
5556225730
Email
aescalan@ifc.unam.mx

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34987304
Citation
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.
Results Reference
result
Links:
URL
https://lanr.ifc.unam.mx
Description
Web Page of the Research and Development Laboratory of Interactive Applications for Neuro-Rehabilitation (LANR) of the UNAM

Learn more about this trial

Changes in Motor Function and Brain Connectivity on Subacute Stroke Patients, Associated With Videogame Therapy

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