Comparative Effect of virtual reality-based aerobic exercises and circuit-based interval training on endurance and neuropathic pain in person with paraplegia
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
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 |
- Spinal cord injury subject were atleast 3 month post SCI.
- ASIA A-D
- Paraplegic with 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.
EXCLUSION CRITERIA
- 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.
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 %
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- All
入选标准
- •Spinal cord injury subject were atleast 3 month post SCI.
- •ASIA A-D The neurological level of injury T2 to L
- •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.
排除标准
- •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.
研究者
AATIF HASAN
ISIC Institute of Rehabilitation Sciences
