Efficacy of Neurofeedback EEG training before virtual reality enhanced partial body weight supported treadmill training in improving neuropsychological status, balance and quality of life in incomplete spinal cord injury-A randomized clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Walking index for Spinal Cord Injury (WISCI)-II
研究概览
简要总结
The present study is a single-blinded, three-arm parallel-group randomized clinical trial which will include a total of 60 subjects diagnosed with incomplete spinal cord injury, (15% dropouts) will be selected based on inclusion criteria. The primary objective of the study is to evaluate the effectiveness of NF-EEG training before virtual reality enhanced partial body weight supported treadmill training and conventional physiotherapy in improving neuropsychological status, static & dynamic standing balance, walking index and quality of life in subjects with incomplete spinal cord injury. Before initiation of the study, subjects will be explained the purpose and procedure of the study. Thereafter written informed consent will be obtained from each subject and will undergo pre- intervention assessment by using Walking index for Spinal Cord Injury (WISCI)-II, Berg Balance Scale (BBS), Swaymeter, Beck Depression inventory and State-trait anxiety inventory, Modified Ashworth Scale (MAS), ASIA impairment scale and WHOQOL-BREF-participation. Afterwards, they will be randomly allocated into three groups: Group 1 (NF-EEG training prior to Virtual reality and conventional physiotherapy), Group 2 (NF- EEG training prior to conventional physiotherapy) and Group 3 (Conventional physiotherapy). Thereafter subjects of Group 1 (n=20) will undergo NF-EEG training prior to gait rehabilitation using virtual reality enhanced partial body weight supported treadmill training along with conventional physiotherapy. Whereas, Group 2 (n=20) will be treated with NF-EEG training prior to conventional physiotherapy. Subjects of Group 3 (n=20) will be treated with conventional physiotherapy only. Balance and Gait rehabilitation using virtual reality will be given for 30 minutes. Conventional physiotherapy protocol will also be followed for 40 minutes. The intervention will be given for three days a week on alternative days, for 12 weeks to all the subjects. After 12 weeks, post-intervention assessment will be done using same outcome measures as on first day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Age group of 20-40 years.
- •Both male and female.
- •Subjects who will be willing to participate in the study.
- •Subjects with traumatic incomplete SCI.
- •Subjects with Incomplete SCI; ASIA C and ASIA D as per ASIA impairment scale.
- •Subjects with a level of injury at or below the sixth thoracic (T6) vertebrae with preserved trunk balance in the sitting (Sitting Balance Measure scale will be used).
- •Subjects with spasticity Grade ≤ 2 on the Modified Ashworth scale.
- •Duration of injury shall be ≥3 months.
排除标准
- •Subjects having paraplegia because of myelopathy or any other space-occupying lesion.
- •Subjects with Pressure sores will be excluded.
- •Subjects who any have fixed deformity of the lower limb will be excluded.
- •Subjects who are not able to understand the commands of the therapist, having marked visual and hearing impairment, with other medical conditions like Autoimmune disease, and with other neurological disorder, e.g., stroke, Parkinson’s disease, multiple sclerosis, Leprosy/skin disease will be excluded.
结局指标
主要结局
1. Walking index for Spinal Cord Injury (WISCI)-II
时间窗: Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment.
2. Berg Balance Scale (BBS)
时间窗: Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment.
3. Swaymeter
时间窗: Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment.
4. Beck Depression inventory
时间窗: Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment.
5. State-trait anxiety inventory
时间窗: Two points- Pre-test readings before the commencement of treatment and post-test readings after 12 weeks of treatment.
次要结局
- 1. Modified Ashworth Scale (MAS)(2. ASIA impairment scale)
研究者
Shanika Sharma
Lovely Professional University, Phagwara
