Effectiveness of Sensory Electrical Stimulation Augmented Virtual Reality Training in Improving Sitting Balance and Quality of Life in Individuals with Incomplete Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Sitting Balance (Forward reach distance) using Modified Functional Reach Test
研究概览
简要总结
Spinal cord injury (SCI) is a debilitating neurological condition characterized by sensory, motor, autonomic, or bowel dysfunction caused by a lesion to neuronal elements of the spinal cord that leads to functional dependence, asymmetric posture, abnormal balance and deficits in ability to transfer weight. As most of the functional activities performed by individuals with SCI are carried out in sitting position, sitting balance is considered as a prerequisite for effective performance of activities of daily living.
Virtual Reality (VR) and Sensory Electrical Stimulation (SES) are two promising interventions that have shown to improve balance and quality of life (QoL) in individuals with various neurological disorders, but their combined effectiveness has not been explored yet. Hence this research aims to find their effectiveness on sitting balance and quality of life in individuals with incomplete SCI.
Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. One group (Experimental group) will receive SES augmented VR training and conventional physiotherapy 5 times a week for 4 weeks. Whereas the second group (control group) will receive VR training along with conventional physiotherapy for the same duration.
The outcome measurements will be done by mFRT(modified functional reach test), Star test and International Spinal Cord Injury Quality of Life Basic Data Set (IScoS QoL BDS Version 1.0). Variations in the pre and post outcome measurements will help us find out the effectiveness of SES augmented VR on sitting balance and QoL in individuals with incomplete SCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosis of SCI
- •T6- T12 Level of injury
- •ASIA B,C and D
- •Ability to sit unsupported for 10 seconds
- •Minimum of 90 degree shoulder flexion.
排除标准
- •Uncorrected hearing or visual impairment
- •Deformity of upper limb, any other psychiatric, neurological or musculoskeletal impairment
- •History of severe recent urinary tract infection or autonomic dysreflexia
- •Refusal or inability to provide informed consent and inability to follow commands
- •Subjects with any contraindications for electrical stimulation such as pressure sores (grade 2 or more) at the site of stimulation and cardiac pacekmaker.
结局指标
主要结局
Sitting Balance (Forward reach distance) using Modified Functional Reach Test
时间窗: 0 weeks (Baseline, Pre-test) and 4 weeks (Post-test)
次要结局
- Multidirectional reach distance using Star Test (Using Tecnobody Prokin 252)(0 weeks (Baseline, Pre-test) and 4 weeks (Post-test))
- Quality of Life Using International Spinal Cord Society (ISCoS) QoL Basic Data Set Version 1.0(0 weeks (Baseline, Pre-test) and 4 weeks (Post-test))
研究者
Nikhil Chowdhary
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences