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CTRI Number  CTRI/2025/12/098501 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 27/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing VR Games and circuit training exercises to improve endurance and Pain in People with spinal cord injury 
Scientific Title of Study   Comparative Effect of virtual reality-based aerobic exercises and circuit-based interval training on endurance and neuropathic pain in person with paraplegia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  AATIF HASAN 
Designation  MPT (NEUROLOGY) 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  VILLAGE SUNAHRA, POST NAITHALA, DIST. BULANDSHAHR
SECOND FLOOR, INSTITUTE DEPARTMENT, INDIAN SPINAL INJURIES CENTRE, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
Bulandshahar
UTTAR PRADESH
203001
India 
Phone  8476072298  
Fax    
Email  aatifhasan4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Ms Garima Wadhwa  
Designation  Assistant Professor 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  SECOND FLOOR, INSTITUTE DEPARTMENT, INDIAN SPINAL INJURIES CENTRE, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South West
DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ms Garima Wadhwa  
Designation  Assistant Professor 
Affiliation  ISIC Institute of Rehabilitation Sciences 
Address  SECOND FLOOR, INSTITUTE DEPARTMENT, INDIAN SPINAL INJURIES CENTRE, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070

South West
DELHI
110070
India 
Phone  9650086472  
Fax    
Email  garimawdhw@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  ISIC Institute of Rehabilitation Sciences 
Address  SECOND FLOOR, INSTITUTE DEPARTMENT, INDIAN SPINAL INJURIES CENTRE, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
AATIF HASAN   ISIC Institute of Rehabilitation Sciences  SECOND FLOOR, INSTITUTE DEPARTMENT, INDIAN SPINAL INJURIES CENTRE, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi, Delhi 110070
South West
DELHI 
8476072298

aatifhasan4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Circuit Based Interval TRAINING GROUP  30 min. of Circuit Based Interval TRAINING GROUP and conventional physiotherapy for 3 times a week for 4 weeks. 
Intervention  VIRTUAL REALITY BASED AEROBIC EXERCISE  30 min. of virtual reality-based aerobic exercise and conventional physiotherapy for 3 times a week for 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Spinal cord injury subject were atleast 3 month post SCI.
ASIA A-D
The neurological level of injury T2 to L2.
Age 18-55 year
Male and female
Self-reported ability to independently self-propel a manual wheelchair.
Ability to complete 6 minute push test.
Diagnosis of neuropathic pain using the international SCI pain data set.
 
 
ExclusionCriteria 
Details  History of unstable angina within past 1 month.
Resting heart rate more than 120 bpm
Any Uncorrected visual impairment.
Systolic BP more than 180 mm Hg and diastolic BP more than 100 mm Hg.
Self reported active medical issues such as pressure sore and cardiovascular disorders contraindicated for exercise testing
A person with neurological deficit(other than SCI) and uncontrolled psychiatric illness
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Wheelchair Propulsion Test
 
04 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
6 minute push test
 
04 weeks 
International Spinal Cord Injury Pain Basic Data Set
 
04 weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

TITLE: Comparative Effect of virtual reality-based aerobic exercises and circuit-based interval training on endurance and neuropathic pain in person with paraplegia

 

BACKGROUND

Spinal cord injury (SCI) leads to loss of function, sensation, or movement below the level of injury. This often results in reduced endurance and commonly causes neuropathic pain. It affects 250,000 to 500,000 people globally, particularly males aged 16–30, and can be caused by both traumatic and non-traumatic factors. (1) Almost 60-70% of SCI individual suffered from neuropathic pain. 

Virtual Reality (VR) is a computer-generated simulation that creates immersive or non-immersive environments, allowing users to interact with a virtual world. In rehabilitation, VR provides repetitive, task-oriented, and personalized training that can enhance endurance by promoting sustained physical activity. Additionally, VR-based distraction and sensory feedback can help in neuropathic pain management by reducing pain perception.

Circuit-based interval training is an approach that includes a combination of wheelchair propulsion, punching bag boxing, and arm ergometer hand cycling. These are effective aerobic exercises that improve cardiovascular endurance, strength, coordination, and circulation, while also helping reduce neuropathic pain. Combined in a circuit, they provide a comprehensive approach to enhance endurance, strength, and pain management in spinal cord injury rehabilitation. 

While traditional Circuit-based interval training is an approach that includes a combination of wheelchair propulsion, punching bag boxing, and arm ergometer hand cycling exercises combined in a circuit are well-established in improving cardiorespiratory endurance and reducing neuropathic pain, VR-based rehabilitation offers an interactive and engaging approach that may enhance neuroplasticity, pain modulation, and adherence to therapy. However, there is limited research directly comparing these two methods, making it essential to determine which is more effective, sustainable, and beneficial for long-term rehabilitation. Therefore, this research is vital for advancing evidence-based interventions that enhance endurance and alleviate neuropathic pain for individuals with paraplegia.

OBJECTIVES

1.     To identify the effectiveness of virtual reality based aerobic exercise on endurance and neuropathic pain in person with paraplegia.

2.     To identify the effectiveness of circuit-based interval training on endurance and neuropathic pain in person with paraplegia.

3.     To compare the effect of virtual reality-based aerobic exercises and circuit-based interval training on endurance and neuropathic pain in person with paraplegia.

 

HYPOTHESIS:

 

NULL HYPOTHESIS-

HN1: There is no difference between the effect of virtual reality based aerobic exercise and circuit-based interval training on endurance in person with paraplegia.

HN2: There is no difference between the effect of virtual reality based aerobic exercise and circuit-based interval training on endurance in person with paraplegia

 

ALTERNATE HYPOTHESIS-

HA1: There is a significant difference between the effect of virtual reality based aerobic exercise and circuit-based interval training on endurance in person with paraplegia

HA2: There is a significant difference between the effect of virtual reality based aerobic exercise and circuit-based interval training on endurance in person with paraplegia..

 

MATERIALS AND METHODS

STUDY DESIGN: Experimental study design

SAMPLE SIZE: 30 (15 in each group)

(Outcome measure used is Wheelchair Propulsion Test)

Thorat, K. D. (2022). Effectiveness of virtual rehabilitation on functional outcome for wheelchair navigation in patients with spinal cord injury – A pilot study. International Journal of Science and Healthcare Research, 7(2), 322–330. https://doi.org/10.52403/ijshr.20220444

ENROLMENT PERIOD: 6-7 months after RRC and IEC clearance

INCLUSION CRITERIA

 

  1. Spinal cord injury subject were atleast 3 month post SCI.
  2. ASIA A-D
  3. Paraplegic with the neurological level of injury T2 to L2.
  4. Age 18-55 year
  5. Male and female.
  6. Self-reported ability to independently self-propel a manual wheelchair.
  7. Ability to complete 6 minute push test.
  8. Diagnosis of neuropathic pain using the international SCI pain data set.

 

EXCLUSION CRITERIA

 

  1. History of unstable angina within past 1 month.
  2. Resting heart rate more than 120 bpm
  3. Any Uncorrected visual impairment.
  4. Systolic BP more than 180 mm Hg and diastolic BP more than 100 mm Hg.
  5. Self reported active medical issues such as pressure sore and cardiovascular disorders contraindicated for exercise testing.
  6. A person with neurological deficit(other than SCI) and uncontrolled psychiatric illness.

 

TOTAL STUDY DURATION: 4 weeks intervention duration.

 

STUDY PROCEDURES: Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. (Experimental Group 1) will receive virtual reality-based aerobic exercise and conventional physiotherapy for 3 times a week for 4 weeks. (Control Group 2) will receive Circuit-based interval training along with conventional physiotherapy for the same duration.

 

ASSESSMENT TOOLS: Pre- and post-intervention tests will be carried out using-

·       6 minute push test

·       Wheelchair Propulsion Test

·       International Spinal Cord Injury Pain Basic Data Set

 

STATISTICAL ANALYSIS PLAN (SAP):

·       DESCRIPTIVE STATISTICS: Descriptive statistics will be used to calculate mean and standard deviation for quantitative variables (such as age, 6 minute push test, Wheelchair Propulsion Test and International Spinal Cord Injury Pain Basic Data Set) and number and percentages for categorical variables (such as gender)

·       ASSUMPTIONS AND DATA PREPARATION: Normality of data will be checked by Shapiro Wilk Test.

·       INFERENTIAL  STATISTICS TO TEST THE HYPOTHESES: If data is found to be normally distributed then to find the mean difference in endurance and neuropathic pain between group ( Virtual Reality group and Circuit based interval  training group) will be examined by using T test (independent ) and dependent t test used within groups

·       If the data is found to be skewed then

·       Mann-Whitney U test will be used to check the average difference between endurance and neuropathic pain between the groups.

·       Wilcoxin signed rank test will be used to assess the change in score in 6 minute push test, Wheelchair Propulsion Test and International Spinal Cord Injury Pain Basic Data Set within the group

·       Statistical software analysis of subjects will be performed by using software SPSS 21 for Windows version.

·       Data will be managed and processed in excel before importing into SPSS

·       INTERPRETATION OF RESULTS statistical significance will be assessed using alpha level of 5 %

 
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