Virtual Reality Dual Task Training in SCI: Effects on Cognition and Cortical Activation

Not Applicable

Not yet recruiting

• Conditions: Spinal Cord Injury

• Registration Number: NCT07019207
• Lead Sponsor: Istinye University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Study Start: 2025-06-16
• Primary Completion: 2026-01-25
• Study Completion: 2026-03-26

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cortical Hemodynamics (Functional Near-Infrared Spectroscopy)	Pre-treatment (Week 0) and after treatment (Week 6)	A portable functional near-infrared spectroscopy (fNIRS) system (Brite MKIII, Artinis, The Netherlands) will be used to monitor hemodynamic changes during patients' cognitive tasks. Optode placement will be based on previous studies and Brodmann areas. Data will be simultaneously collected and analyzed using OxySoft software. The device includes ten emitters and eight detectors arranged in a 2 × 12 channel layout, covering cortical regions related to upper extremity representation. Channels will be symmetrically distributed across hemispheres. The emitter-detector distance will be set at 30 mm, and light wavelengths of 763 nm and 842 nm will be used. HbO₂ concentrations in regions of interest (PFC, SFC, SMA, and PMC) will be measured. ΔHbO₂, ΔHbR, and ΔHbT values will be recorded per channel as time-series data in units of μmol/L.
Upper Extremity Functional Level (Fugl-Meyer Motor Assessment Scale - Upper Extremity (FMA))	Pre-treatment (Week 0) and after treatment (Week 6)	The scale consists of five sections: motor function (upper and lower extremities), sensory function, balance, joint range of motion, and joint pain; however, the motor function assessment is the most commonly used section. It includes 33 items, each scored on a three-point ordinal scale based on the participant's ability to perform the task. For the upper extremity motor function, a participant can achieve a maximum score of 66. Higher scores indicate better motor function.
Cognition (Montreal Cognitive Assessment Test (MoCA))	Pre-treatment (Week 0) and after treatment (Week 6)	MoCA consists of nine subtests. It assesses multiple cognitive domains, including executive functions (e.g., trail making), visuospatial abilities (clock drawing task and three-dimensional cube copying), attention, concentration, working memory, language (e.g., a three-item naming task with low-familiarity animals), short-term memory, and orientation to time and place. These correspond to the following MoCA subtests: trail making, visuoconstructional skills, naming, attention, sentence repetition, verbal fluency, abstraction, delayed recall, and orientation. A score of 21 or higher on the scale is considered normal.
Sitting Balance (Modified Functional Reach Test)	Pre-treatment (Week 0) and after treatment (Week 6)	The test is conducted with the individual seated in a standard wheelchair with footrests. The measuring rod is mounted on the wall at the level of the acromion process of the shoulder. To measure reach, the ulnar styloid process is used as the anatomical landmark. The participant is asked to flexion their shoulder to 90 degrees for the first reading, then to reach as far as possible without any support for the second reading, and finally to return to the starting position. The difference between the two readings is recorded. Each participant is given three trials, and the average is calculated.

Secondary Outcome Measures

Name	Time	Method
Gross grip strength (Jamar hand dynamometer)	Pre-treatment (Week 0) and after treatment (Week 6)	Standard grip strength is measured using the Jamar hand dynamometer (Pro Med Products, Atlanta, GA) in the standardized test position recommended by the American Society of Hand Therapists, with the patient seated, the arm positioned at the side of the body, and the elbow flexed at 90 degrees. Participants are instructed to squeeze the dynamometer with maximum effort and then fully relax. This procedure is repeated three times for both the right and left hands, and the average values are calculated in kilograms.
Occupational Performance (Canadian Activity Performance Scale (COPM))	Pre-treatment (Week 0) and after treatment (Week 6)	The Canadian Occupational Performance Measure (COPM) is a semi-structured, client-centered scale designed to detect changes over time in self-reported occupational performance. It consists of five steps and three scoring phases: (1) The individual identifies occupations in the areas of self-care, productivity, and leisure, rating their importance on a scale from 1 (not important at all) to 10 (extremely important). (2) Using these ratings, the individual selects the five most important occupations. (3) The individual then rates their performance and satisfaction with performance in these selected occupations on a scale from 1 to 10. Two distinct dimensions-Performance and Satisfaction-are evaluated. Each dimension is scored from 1 to 10, with a maximum score of 10 for each. Higher scores indicate better performance and greater satisfaction.
Patient Satisfaction (Patient Satisfaction Short Evaluation Form)	Pre-treatment (Week 0) and after treatment (Week 6)	The level of patient satisfaction with the treatment they receive is a critical variable for their adherence to treatment and the continuity of their well-being. The scale developed to measure this can yield scores ranging from 0 to 28. Higher scores indicate a greater level of dissatisfaction.

Trial Locations

Locations (1)

Hüsnü Ayık Care Center; 🇹🇷 İstanbul, Beylikdüzü, Turkey