Upper Limb Spinal Cord Stimulation for Rehabilitation Enhancement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
研究概览
简要总结
In the United Kingdom, there are more than 1000 new cases of spinal cord injury (SCI) each year, with around half of these injuries affecting the cervical spine. People who have reduced function and control affecting their upper limbs may have difficulty carrying out activities of daily living (ADLs), significantly affecting their independence. Recovering even partial upper limb function is a top priority among tetraplegics.
Regaining voluntary function in the upper limb can have a huge impact on quality of life. Using TSCS in the upper limb for acute SCI can benefit patients early in their rehabilitation, and may reduce the number of patients with problematic spasticity at discharge. Transcutaneous spinal cord stimulation (TSCS) may provide a low-cost method of improving function and spasticity in this cohort.
The aim of this feasibility study is to assess and compare the impact of adding TSCS to the standard rehabilitation of inpatients with acute SCI, compared to a sham (placebo) TSCS intervention added to standard rehabilitation, in an effort to enhance upper limb control and function.
详细描述
Recruitment:
Participants will be recruited from the Royal National Orthopaedic Hospital. A member of our research team will contact participants after they have received this information sheet to discuss participation in the study and answer any questions. People who would like to take part in the study will be asked to attend an initial session to see if they are able to tolerate non-invasive SCS.
Intervention:
Eligible participants will then be randomised either into the intervention group, where they will receive TSCS or sham TSCS in addition to their regular inpatient rehabilitation. We are using this trial design to assess whether adding TSCS to regular inpatient rehabilitation enhances recovery and voluntary function in this participant cohort, and to test that there is not a placebo effect.
For both the sham and intervention groups, we will carry out regular assessments. Some of these assessments will be part of standard care as an inpatient at the RNOH, and others will be additional. Please see the outcome measures for further information about these assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 18
- •Recent spinal cord injury (inpatient at the RNOH)
- •Spinal cord injury level C1-C8
- •Willing and able to provide informed consent
排除标准
- •Women who are pregnant, planning pregnancy or breastfeeding
- •Those who have a cardiac pacemaker
- •Active device at stimulating electrode site
- •Any other musculoskeletal diagnosis affecting the upper limbs
- •Spinal malignancy
- •Spinal cord injury due to cancerous growth
- •Auto-immune disorder
- •Ongoing infection
- •Uncontrolled autonomic dysreflexia
- •Complex regional pain syndrome
- •Neurological degenerative diseases
- •Peripheral nerve damage affecting the upper limbs
- •Taking part in a conflicting research study
- •People who are unable to tolerate TSCS during their first session
研究组 & 干预措施
Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation
Standard inpatient rehabilitation received at the Royal National Orthopaedic Hospital NHS Trust
干预措施: Sham transcutaneous spinal cord stimulation (placebo) added to inpatient rehabilitation (Other)
Transcutaneous spinal cord stimulation added to inpatient rehabilitation
Transcutaneous spinal cord stimulation added to standard inpatient rehabilitation, targetting the upper limbs, received at the Royal National Orthopaedic Hospital NHS Trust
干预措施: Transcutaneous spinal cord stimulation added to inpatient rehabilitation (Other)
结局指标
主要结局
Change in International Standards of Neurological Classification for SCI (ISNC-SCI).
时间窗: 30 minutes
This is a is a clinician-administered scale used to classify the severity (completeness) of injury in individuals with SCI.
次要结局
- Individual goal planning(20 minutes)
- Electromyography (EMG) assessments(90 minutes)
- Tetraplegic upper limb activity questionnaire (TUAQ)(30 minutes)
- Modified Ashworth Scale (MAS)(20 minutes)
- Range of Motion (ROM)(20 minutes)
- Spinal Cord Independence Measure (SCIM)(30 minutes)
- International SCI data sets quality of life basic data set (SCI-QoL)(15 minutes)
- Semi-structured interview(60 minutes)