A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Robotic Gait Training in Trunk Muscle Activity and Walking Index in Chronic Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- 10-Meter Walk Test (10MWT)
研究概览
简要总结
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks.
Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.
详细描述
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment robotic gait training (RGT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+RGT on health-related quality of life (HRQOL), compared to RGT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with paraplegia and 6 subjects with tetraplegia will be recruited. Once subject is identified to be eligible for the study and is agreeable to participate into the study, he/she will undergo Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks.
Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment. During tSCS, two surface electrodes will be positioned in between the vertebral processes located generally one vertebral segment rostral and one vertebral segment caudal to the site of injury. Reference/Ground electrodes placed over the ASIS. It will be on biphasic mode with an overlap frequency of 10kHz, Burst Frequency of 30Hz, Pulse width of 1ms. Stimulation intensity ranges from 5-100 mA and will be adjusted according to the patient's response. The tSCS stimulation duration for each session will be 45 minutes in conjunction with the RGT training
Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline (within 1 week before the starting of Phase 1 of training), Post-Phase 1 (within 1 week after Phase 1 of training) and Post-Phase 2 (within 1 week after Phase 2 of training).
A satisfaction survey on the intervention "RGT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;
- •Age between 21 to 65 years old;
- •Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;
- •Spinal cord injury level: T1- L1, or C2-C8;
- •SCI-TCT Score > 13;
- •Capable of providing an informed consent;
- •Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;
- •Meets prerequisites for Ekso wearable robotic exoskeleton training.
排除标准
- •Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator;
- •Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment;
- •Unstable or uncontrolled autonomic dysreflexia;
- •Requires ventilator support;
- •Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator;
- •Skin conditions that limit the application of tSCS electrodes;
- •Active implanted medical devices that may be affected by tSCS;
- •Pregnant, planning to become pregnant or breastfeeding;
- •Concurrent participation in another drug or device trial that may interfere with this study;
- •Participated in wearable exoskeleton training within the last 3 months prior to enrolment.
- •Peripheral nerve injury or significant Lumbar Radiculopathy
研究组 & 干预措施
RGT+ conventional physiotherapy
16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks
干预措施: RGT+ conventional physiotherapy (Device)
RGT+ tSCS + conventional physiotherapy
Phase 2: 16 sessions of RGT training + transcutaneous electrical stimulation (tSCS) + functional training in 8-10 weeks.
干预措施: RGT+ tSCS + conventional physiotherap (Device)
结局指标
主要结局
10-Meter Walk Test (10MWT)
时间窗: Week 17
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
时间窗: Week 17
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Walking Index in Spinal Cord Injury-II (WISCI-II)
时间窗: Week 17
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Central motor conduction time (CMCT)
时间窗: Week 17
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
International standards for Neurological Classification of SCI (ISNCSCI)
时间窗: Week 17
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
时间窗: Week 0
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
时间窗: Week 8
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Walking Index in Spinal Cord Injury-II (WISCI-II)
时间窗: Week 0
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Walking Index in Spinal Cord Injury-II (WISCI-II)
时间窗: Week 8
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
10-Meter Walk Test (10MWT)
时间窗: Week 0
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
10-Meter Walk Test (10MWT)
时间窗: Week 8
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
Central motor conduction time (CMCT)
时间窗: Week 0
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
Central motor conduction time (CMCT)
时间窗: Week 8
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
International standards for Neurological Classification of SCI (ISNCSCI)
时间窗: Week 0
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
International standards for Neurological Classification of SCI (ISNCSCI)
时间窗: Week 8
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
次要结局
- EQ5D(Week 17)
- Modified Tardieu Scale(Week 17)
- EMG measurement(Week 17)
- EQ5D(Week 0)
- EQ5D(Week 8)
- Modified Tardieu Scale(Week 0)
- Modified Tardieu Scale(Week 8)
- EMG measurement(Week 0)
- EMG measurement(Week 8)