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IRCT20260623069931N2 IRCT 2026-08-11 Tehran University of Medical Sciences Virtual reality tourism for adult With Spinal Cord Injury Effects of Adaptive Virtual Adventure Sport Tourism on Positive Affect and Well-Being in Adults With Spinal Cord Injury 2026-08-16 anticipated 80 Recruiting https://irct.ir/trial/92357 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants will be randomized individually in a 1:1 ratio to the adaptive VR intervention or active control group using computer-generated permuted blocks of four and six. Randomization will be stratified by neurological level (tetraplegia vs paraplegia) and baseline positive affect and well-being score (below vs at or above the sample median). An independent researcher not involved in recruitment, intervention delivery, or outcome assessment will generate the allocation sequence. Group assignments will be placed in sequentially numbered, opaque, sealed envelopes and opened by the intervention coordinator only after completion of baseline assessment, Blinding description: Participants and intervention personnel will not be blinded because of the visible differences between immersive VR and two-dimensional video viewing. Outcome assessments will be conducted by a research assistant who will not attend intervention sessions and will remain unaware of group allocation. Participants will be reminded not to disclose their assigned condition during assessments. For the primary analysis, groups will be coded as A and B, and the data analyst will remain blinded to group identity until the main analysis is completed. N/A Spinal Cord Injury. Intervention 1: Intervention group: Participants will receive 12 supervised sessions of adaptive immersive virtual reality adventure sport tourism over 4 weeks, with 3 sessions per week. Using Meta Quest 3, participants will engage in virtual coastal kayaking, hand-cycling, wheelchair-accessible trail navigation, seated sailing, and destination exploration. Activities will be adapted to participants’ functional abilities and comfort. Intervention 2: Control group: Participants will receive 12 supervised sessions of non-immersive two-dimensional travel videos over 4 weeks, with 3 sessions per week. Videos will be viewed on a 24-inch monitor with session duration, setting, and facilitator contact matched to the intervention group. The control condition will not include immersion, motion tracking, interactive tasks, performance feedback, adaptive challenge, or active navigation. No - There is not a plan to make this available Justification or reason for not sharing IPD is Individual participant data will not be publicly shared to protect participant privacy and confidentiality
public Hossein Faridniya
16 Azar Street, Enghelab Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417466191 +98 936 387 5989 hossein.faridniya@ut.ac.ir Tehran University of Medical Sciences scientific Hossein Faridniya
16 Azar Street, Enghelab Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417466191 +98 936 387 5989 hossein.faridniya@ut.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age 18–65 years Spinal cord injury for at least 6 months AIS grade A–D Ability to perform light-to-moderate upper-limb activity while seated Adequate vision and hearing to participate in the intervention Successful completion of the VR familiarization session 18 years 65 years Male History of seizure within the past year Severe vestibular disorder or motion sickness Acute or uncontrolled autonomic dysreflexia Unstable cardiovascular or respiratory condition Active pressure injury Severe uncorrected visual impairment Acute psychiatric crisis Cognitive or communication impairment preventing participation Concurrent participation in another VR-based intervention Planned change in mood-related medication during the study period G82 Paraplegia (paraparesis) and quadriplegia (quadriparesis) Rehabilitation Rehabilitation Intervention group: Participants will receive 12 supervised sessions of adaptive immersive virtual reality adventure sport tourism over 4 weeks, with 3 sessions per week. Using Meta Quest 3, participants will engage in virtual coastal kayaking, hand-cycling, wheelchair-accessible trail navigation, seated sailing, and destination exploration. Activities will be adapted to participants’ functional abilities and comfort Control group: Participants will receive 12 supervised sessions of non-immersive two-dimensional travel videos over 4 weeks, with 3 sessions per week. Videos will be viewed on a 24-inch monitor with session duration, setting, and facilitator contact matched to the intervention group. The control condition will not include immersion, motion tracking, interactive tasks, performance feedback, adaptive challenge, or active navigation SCI-specific positive affect and well-being T-score. Timepoint: Baseline, 24–72 hours post-intervention, and 30-day follow-up. Method of measurement: SCI-QOL Positive Affect and Well-Being Short Form 10a (SCI-QOL PAWB SF10a). Tehran University of Medical Sciences Approved 2025-04-20 Sport Sciences Research Institute Ethics Committee No. 3, 5th Alley, Mir Emad St., Ostad Motahari St., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)