Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Severity of Gleno-humeral Subluxation
研究概览
简要总结
To determine whether functional electrical stimulation (FES) promotes neurological and physical recovery in patients with spinal cord injury (SCI).
The researchers will investigate the extent of functional recovery in patients with spinal cord injury who receive functional electrical stimulation in the upper extremities compared with patients who do not receive FES.
详细描述
A randomized, controlled, single-blinded, in-subject controlled (A-B type) trial will be performed in patients with SCI receiving an upper extremities non-FES assisted exercise protocol compared with patients receiving upper extremities ergometry in combination with FES. Neurological and functional outcome measures will be obtained at baseline (time 0), after 1st 4 months of intervention (4 months), after 1 month washout (5 months),after 2nd 4 months intervention (9 months), and 3 month after completing the last intervention (12 months).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male, Female, age 18-55, all ethnic groups
- •Spinal Cord Injury, traumatic and non-traumatic
- •C1-C6 neurological level
- •ASIA class A-B
- •Chronic injury > 12 months and < 20 years from the injury
- •No upper-extremity electrical stimulation in the previous 4 weeks
- •Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
- •Baseline physical activity is kept stable
- •Pain and antispasticity medications dose are kept stable
- •Subjects are legally able to make their own health care decisions
排除标准
- •Associated lower motor neuron/peripheral nerve injury in the C1-C6 levels
- •Presence of pacemaker
- •Presence of cancer
- •History of seizures
- •Women who are pregnant
结局指标
主要结局
Severity of Gleno-humeral Subluxation
时间窗: 12 months
This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally
Capabilities of the Upper Extremity (CUE) Test
时间窗: Baseline, 4 months, 5 months, 9 months, 12 months
This is a routine exam performed for people with spinal cord injury.The CUE test is a 32-item interview. It is designed to self-assess upper extremity performance on a 7-point scale (nominal scale, \[45\]).Subjects are questioned while sitting in their wheelchairs. A brief description of the test will be read to the subjects and then questions asked, one at a time. Subjects will give verbal responses on a 7-point likert scale. total score possible is 0- 225, higher the score better outcome
Box and Blocks (BB) Test
时间窗: Baseline, 4 months, 5 months, 9 months, 12 months
This is a routine exam performed for people with spinal cord injury. The BB assesses gross hand function. Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The BB requires subjects to reach for, lift, and move one inch cubes across a divider inside a wooden box. The amount of time (seconds) subject is able to move around is measured. Higher scores mean better outcome by timed test.
Modified Ashworth Scale
时间窗: Baseline, 4 months, 5 months, 9 months, 12 months
This is a routine exam performed for people with spinal cord injury.The Modified Ashworth Scale assesses muscle resistance to passive movement. The evaluator moves the joint through the available range of motion and assigns a score from 0-4, where 0 is no tone and 4 is fixed limb (ordinal scale, \[44\]).Subjects are tested in a seated position preferably in their wheelchairs. The subjects' upper extremity is stabilized by the examiner above and below the joint to be tested. Then the joint is quickly moved through the previously determined subjects' maximum range of motion
Jebsen-Taylor Hand Function (JTHF) Test
时间窗: Baseline, 4 months, 5 months, 9 months, 12 months
This is a routine exam performed for people with spinal cord injury.The JTHF test is a 7-item test designed to objectively assess various hand functions and speed of performance (ordinal scale, \[46\]). Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The JTHF requires subjects to reach for, lift, and in some cases manipulate small objects. smallest time in seconds mean a better outcome
次要结局
- Range of Motion(Baseline, 4 months, 5 months, 9 months, 12 months)
- Action Research Arm (ARA) Test(Baseline, 4 months, 5 months, 9 months, 12 months)
- Numerical Rating Scale (NRS).(Baseline, 4 months, 5 months, 9 months, 12 months)
研究者
Cristina Sadowsky, M.D.
Director, Paralysis Restoration Clinic, International Center for Spinal Cord Injury, Kennedy Krieger Institute; Assistant Professor, Johns Hopkins University School of Medicine
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.