Clinical trial NCT07019207: Virtual Reality Dual Task Training in SCI: Effects on Cognition and Cortical Activation
Official title: The Effect of Virtual Reality-Based Dual-Task Training on Cognition, Cortical Activation, and Functional Level in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injury
Keywords: Dual-task
Virtual Reality
Cognition
Spinal Cord Injuries
Cortical Activation
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants who meet the inclusion criteria will be randomly assigned to one of three groups: a VR-based dual-task training with motor imagery group, a VR-based dual-task training without motor imagery group and a control group. Each arm will receive a distinct intervention protocol concurrently over the same study period.
Primary purpose: TREATMENT

Brief summary: Spinal cord injury (SCI) is a severe neurological condition characterized by the loss of motor and sensory functions due to damage in the spinal cord or the nerves branching from it. Although studies investigating cognitive function after SCI are limited, it has been reported that up to 60% of individuals experience cognitive impairments. Because of impaired motor control, patients may need to invest more cognitive effort to perform even simple movements. This situation can negatively affect their ability to carry out multiple tasks at the same time and to respond effectively to environmental threats while walking, which may increase their risk of falling. Although the presence of cognitive changes after SCI is recognized in the literature, there are only a few studies examining the effects of rehabilitation on cortical activation, highlighting the need for innovative approaches to improve both motor and cognitive functions. The aim of this randomized controlled study is to investigate the effects of virtual reality (VR)-based dual-task training, both with and without motor imagery, on cortical activation, cognition, and functional level in individuals with SCI. Participants who meet the inclusion criteria will be recruited from the Turkish Spinal Cord Paralytics Association and will be randomly assigned to one of three groups: (1) a VR-based dual-task training group including motor imagery (n=15), (2) a VR-based dual-task training group without motor imagery (n=15), and (3) a control group (n=15). After obtaining informed consent and recording demographic data, pre-treatment (T0) and post-treatment (T1) assessments will be conducted. Cortical activation will be measured using functional near-infrared spectroscopy (fNIRS), grip strength with a Jamar hand dynamometer, upper extremity functional level with the Fugl-Meyer Assessment, sitting balance with the Modified Functional Reach Test, cognitive status with the Montreal Cognitive Assessment (MoCA), and occupational performance with the Canadian Occupational Performance Measure (COPM). Patient satisfaction and general health status will also be recorded. In addition to upper extremity strengthening exercises, patients in the VR groups will perform a cognitive-motor dual-task game developed by the researchers, which is played with VR glasses. The motor imagery group will complete the tasks while visualizing themselves standing and walking, while the other group will play the same game without walking imagery, from a wheelchair perspective. The game will involve motor tasks such as crossing the street between moving cars and walking on the sidewalk without bumping into people, as well as cognitive tasks based on the Stroop test, which will become progressively more difficult through three stages. Completing all stages will take approximately 20 minutes. Patients in the control group will only receive upper extremity strengthening exercises. The intervention will last for 12 sessions, conducted twice a week. The findings of this study are expected to emphasize the importance of simultaneous motor and cognitive rehabilitation in individuals with SCI and to contribute scientifically to the use of VR-supported innovative approaches in rehabilitation practices.


Eligibility criteria: Inclusion Criteria:

* Being between 18-60 years old
* Having full or partial paraplegia
* Having an injury level of T1 or below
* Having at least 90° active shoulder flexion and abduction
* Having at least 3 months since the injury

Exclusion Criteria:

* Musculoskeletal pain greater than 5 out of 10 on the Visual Analog Scale
* Patients who cannot sit in a chair for at least 30 minutes
* Presence of deformities or color changes in joints that prevent upper extremity movements
* Patients who have had fractures or operations on the upper extremity within the last 6 months
* History of head trauma
* Presence of a disease known to affect cognitive impairment
* Severe deafness, blindness or significant physical illnesses that cause communication disorders and prevent patients from participating in the study
* Presence of any known cardiovascular disease
* Conditions in which virtual reality glasses are contraindicated (epilepsy; vertigo and similar severe movement disorders)
* Patients with a history of stroke or progressive neurodegenerative disease
* Patients with neuromuscular disease
* Patients with uncontrolled epilepsy
* Concurrent participation in other studies or treatments

Primary outcomes:
measure: Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
measure: Upper Extremity Functional Level (Fugl-Meyer Motor Assessment Scale - Upper Extremity (FMA))
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
measure: Cognition (Montreal Cognitive Assessment Test (MoCA))
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
measure: Sitting Balance (Modified Functional Reach Test)
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
Secondary outcomes:
measure: Gross grip strength (Jamar hand dynamometer)
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
measure: Occupational Performance (Canadian Activity Performance Scale (COPM))
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
measure: Patient Satisfaction (Patient Satisfaction Short Evaluation Form)
timeFrame: Pre-treatment (Week 0) and after treatment (Week 6)
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Hüsnü Ayık Care Center
state: Beylikdüzü
Study officials:
affiliation: Istinye University
name: NURGÜL DÜRÜSTKAN ELBAŞI
role: STUDY_CHAIR
References:
citation: Cheng C, Liu T, Zhang B, Wu X, Song Z, Zhao Z, Ren X, Zhao M, Su Y, Wang J. Effects of robot-assisted hand function therapy on brain functional mechanisms: a synchronized study using fNIRS and sEMG. Front Med (Lausanne). 2024 Oct 31;11:1411616. doi: 10.3389/fmed.2024.1411616. eCollection 2024.
citation: Zhou Y, Zhao Y, Xiang Z, Yan Z, Shu L, Xu X, Zhang L, Tian X. A dual-task-embedded virtual reality system for intelligent quantitative assessment of cognitive processing speed. Front Hum Neurosci. 2023 Mar 30;17:1158650. doi: 10.3389/fnhum.2023.1158650. eCollection 2023.
citation: Chiaravalloti ND, Weber E, Wylie G, Dyson-Hudson T, Wecht JM. The impact of level of injury on patterns of cognitive dysfunction in individuals with spinal cord injury. J Spinal Cord Med. 2020 Sep;43(5):633-641. doi: 10.1080/10790268.2019.1696076. Epub 2019 Dec 20.