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

NCT05283369 | Recruiting

• 1 other identifier: 127/21
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Hemiparesis; Subacute; virtual rehabilitation; Functional Magnetic Resonance Imaging; videogames

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Extremity Test (FMUE)

  The Fugl-Meyer test for Upper extremity. To assess level of motor disability

  Baseline, 8 Weeks

Secondary Outcomes (6)

• Wolf Motor Function Test (WMFT)

  Baseline, 8 Weeks

• Chedoke Arm and Hand Activity Inventory (CAHAI-7)

  Baseline, 8 Weeks

• Barthel Index

  Baseline, 8 Weeks

• Trail Making Test (TMT)

  Baseline, 8 Weeks

• Corsi block-tapping test

  Baseline, 8 Weeks

Other Outcomes (1)

• Changes in brain functional connectivity, measured by fMRI

  Baseline, 8 Weeks

Study Arms (2)

Videogame therapy

EXPERIMENTAL

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

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.

Other: Conventional therapy

Interventions

Videogame therapy DEVICE

The usual dose of conventional physical therapy, plus 300 minutes a week of in-home videogame therapy for 8 weeks.

Videogame therapy

Conventional therapy OTHER

The usual dose of physical and occupational therapy, for 8 weeks.

Conventional therapy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Nacional Autonoma de Mexico: lead
• El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez: collaborator

Study Sites (1)

Ana María Escalante-Gonzalbo

Mexico City, Tlalpan, CDMX, 14269, Mexico

RECRUITING

Related Publications (1)

• 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.

  PMID: 34987304 RESULT

Related Links

• Web Page of the Research and Development Laboratory of Interactive Applications for Neuro-Rehabilitation (LANR) of the UNAM

MeSH Terms

Conditions

Ischemic Stroke; Paresis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ana María Escalante-Gonzalbo, MCompSci

  Universidad Nacional Autonoma de Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana María Escalante-Gonzalbo, MCompSci

CONTACT

(52)5523397244; aescalan@ifc.unam.mx

Yoás S Ramírez-Graullera, MCompSci

CONTACT

(52)5527409802; ygraullera@ifc.unam.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: One control group will receive conventional rehabilitation therapy, and one experimental group will receive telerehabilitation videogame therapy.

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 17, 2022
• Study Start: December 2, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)