Protocol summary

Study aim
To examine the effect of a four-week adaptive virtual adventure sport tourism intervention on SCI-specific positive affect and well-being in adults with spinal cord injury
Design
Assessor-blinded, two-arm, parallel-group randomized controlled trial with 1:1 allocation and concealed computer-generated randomization
Settings and conduct
The study will be conducted at two specialist spinal cord injury rehabilitation centers in Tehran, Iran. Eligible participants will complete baseline assessments and will then be randomly assigned using the RAND function in Microsoft Excel to either the adaptive VR intervention or active control group. Interventions will be delivered in supervised sessions, and outcomes will be assessed at baseline, 24–72 hours after the four-week intervention, and at 30-day follow-up
Participants/Inclusion and exclusion criteria
Adults aged 18–65 years with SCI for ≥6 months and AIS grade A–D will be included. Major exclusions will be seizures, severe motion sickness, unstable medical conditions, active pressure injury, severe visual impairment, acute psychiatric crisis, cognitive impairment, or concurrent VR intervention
Intervention groups
Intervention group: Participants will receive 12 supervised sessions of adaptive immersive VR adventure sport tourism over 4 weeks using Meta Quest 3. Activities will include virtual kayaking, hand-cycling, accessible trail navigation, seated sailing, and destination exploration, with individualized accessibility and comfort adaptations. Active control group: Participants will receive 12 matched sessions of two-dimensional travel videos without immersion, interaction, navigation, or adaptive challenge
Main outcome variables
SCI-specific positive affect and well-being measured by the SCI-QOL PAWB SF10a T-score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260623069931N2
Registration date: 2026-08-11, 1405/05/20
Registration timing: prospective

Last update: 2026-08-11, 1405/05/20
Update count: 0
Registration date
2026-08-11, 1405/05/20
Registrant information
Name
Hossein Faridniya
Name of organization / entity
University of Tehran
Country
Iran (Islamic Republic of)
Phone
+98 936 387 5989
Email address
hossein.faridniya@ut.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-08-16, 1405/05/25
Expected recruitment end date
2026-09-24, 1405/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Adaptive Virtual Adventure Sport Tourism on Positive Affect and Well-Being in Adults With Spinal Cord Injury
Public title
Virtual reality tourism for adult With Spinal Cord Injury
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 65 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sport Sciences Research Institute Ethics Committee
Street address
No. 3, 5th Alley, Mir Emad St., Ostad Motahari St., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2025-04-20, 1404/01/31
Ethics committee reference number
IR.SSRC.REC.1404.029

Health conditions studied

1

Description of health condition studied
Spinal Cord Injury
ICD-10 code
G82
ICD-10 code description
Paraplegia (paraparesis) and quadriplegia (quadriparesis)

Primary outcomes

1

Description
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)

Secondary outcomes

empty

Intervention groups

1

Description
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
Category
Rehabilitation

2

Description
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
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Specialist Spinal Cord Injury Rehabilitation Center, Tehran
Full name of responsible person
Hossein Faridniya
Street address
Rofeideh Rehabilitation Hospital
City
Tehran
Province
Tehran
Postal code
1935973476
Phone
+98 21 2223 3010
Email
solalll.19966@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali saberi
Street address
16 Azar Street, Enghelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417466191
Phone
+98 21 6111 3411
Email
hossein.faridniya@ut.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
2
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
16 Azar Street, Enghelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417466191
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
16 Azar Street, Enghelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417466191
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Faridniya
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
16 Azar Street, Enghelab Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417466191
Phone
+98 936 387 5989
Email
hossein.faridniya@ut.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Individual participant data will not be publicly shared to protect participant privacy and confidentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study protocol and related study documents
When the data will become available and for how long
After publication of the main study results
To whom data/document is available
Qualified researchers upon reasonable request to the corresponding author
Under which criteria data/document could be used
For academic and research purposes, subject to a reasonable request, approval by the study investigators, and compliance with ethical and confidentiality requirements
From where data/document is obtainable
The corresponding author of the study
What processes are involved for a request to access data/document
Requests will be submitted to the corresponding author and reviewed by the study investigators for scientific purpose, ethical compliance, and confidentiality requirements
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