A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Upper Limb Robotics Training in Upper Limb Rehabilitation in Patients With Tetraplegic 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
- GRASSP 2
研究概览
简要总结
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluates the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 to 8 subjects with C2-8 level injuries will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1, Post-Phase 2, and 4 weeks Follow-up. A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at end of the study.
详细描述
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with C2-8 level injuries 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 upper limb robotic training (ULRT) + conventional occupational therapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
This study will use the locally developed H-Man arm rehabilitation robot and Esoglove™ PRO hand rehabilitation system for ULRT. The H-Man robot, a table-top, portable, 2D planar, end-effector with virtual reality feedback is designed to deliver self-paced, repetitive reaching arm movements. The soft robotic glove EsoGlove enables patients to carry out upper-limb rehabilitation with multiple training modes, such as passive training, active-assisted range of motion training, and bilateral training. Participants could choose either H-man or Esoglove, or use both alternatively for ULRT training, according to their functional impairment. ULRT will be paired with functional training during the intervention sessions.
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), Post-Phase 2 (within 1 week after Phase 2 of training), and 4 weeks Post Phase 2
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 6 months to 5 years from the diagnosis of the traumatic SCI;
- •Participants between 21 and 80 years of age;
- •C2-8 level injuries;
- •ISNCSCI-UEMS >25,
- •Pinch force > 25 N;
- •Grasp force > 100 N;
- •Able to perform the box and block test;
- •Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance);
- •Capable of providing an informed consent;
- •Cleared by Neurosurgeons/Orthopaedic Surgeon for tSCS;
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.
- •Has an autoimmune etiology of spinal cord dysfunction/injury
- •History of additional neurologic disease, such as stroke, multiple sclerosis and traumatic brain Injury.
- •Pain in shoulder and/or hand which will be inhibitory towards rehabilitative therapy.
- •Severe Upper limb contractures.
- •Acute Medical conditions to Upper limb (ie Fractures that would limit ROM and/or weightbearing).
- •Participants who are pregnant.
研究组 & 干预措施
ULRT+ conventional occupational therapy
16 sessions of ULRT + conventional occupational therapy in 8-10 weeks
干预措施: ULRT + conventional occupational therapy (Device)
ULRT + tSCS + conventional occupational therapy
Phase 2: 16 sessions of ULRT training + transcutaneous electrical stimulation (tSCS) + conventional occupational therapy in 8-10 weeks
干预措施: ULRT + tSCS + conventional occupational therapy (Device)
结局指标
主要结局
GRASSP 2
时间窗: Week 0
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
GRASSP 2
时间窗: Week 8
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
GRASSP 2
时间窗: Week 16
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
GRASSP 2
时间窗: Week 20
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
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)
International standards for Neurological Classification of SCI (ISNCSCI)
时间窗: Week 16
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 20
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)
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.
Central motor conduction time (CMCT)
时间窗: Week 16
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 20
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.
Capabilities of Upper Extremity Test (CUE-T)
时间窗: Week 0
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Capabilities of Upper Extremity Test (CUE-T)
时间窗: Week 8
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Capabilities of Upper Extremity Test (CUE-T)
时间窗: Week 16
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Capabilities of Upper Extremity Test (CUE-T)
时间窗: Week 20
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
次要结局
- Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge(Week 0)
- Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge(Week 8)
- Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge(Week 16)
- Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge(Weeks 20)
- Modified Tardieu Scale(Week 0)
- Modified Tardieu Scale(Week 8)
- Modified Tardieu Scale(Week 16)
- Modified Tardieu Scale(Week 20)
- EQ5D(Week 0)
- EQ5D(Week 8)
- EQ5D(Week 16)
- EQ5D(Week 20)
- EMG measurement(Week 0)
- EMG measurement(Week 8)
- EMG measurement(Week 16)
- EMG measurement(Week 20)
- Box and Block Assessment(Week 0)
- Box and Block Assessment(Week 8)
- Box and Block Assessment(Week 16)
- Box and Block Assessment(Week 20)
- Nine Hole Peg Test(Week 0)
- Nine Hole Peg Test(Week 8)
- Nine Hole Peg Test(Week 16)
- Nine Hole Peg Test(Week 20)
- Spinal Cord Injury Independence Measure (SCIIM)(Week 0)
- Spinal Cord Injury Independence Measure (SCIIM)(Week 8)
- Spinal Cord Injury Independence Measure (SCIIM)(Week 16)
- Spinal Cord Injury Independence Measure (SCIIM)(Week 20)
- Modified Goal attainment Scale (GAS)(Week 0)
- Modified Goal attainment Scale (GAS)(Week 8)
- Modified Goal attainment Scale (GAS)(Week 16)
- Modified Goal attainment Scale (GAS)(Week 20)