Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (SCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Grasp Release Test
研究概览
简要总结
The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device.
The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).
详细描述
Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual.
In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic SCI with tetraplegia.
- •Male or female.
- •18-65 yrs old.
- •At least 1 yr post-SCI.
- •Tolerate sitting upright at for at least one hour.
- •Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested.
- •Motor grade >1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested.
- •Cognitively and behaviorally capable of complying with the regimen.
排除标准
- •Fracture of the treated limb resulting in loss of range of motion
- •Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study)
- •DVT of the treated extremity
- •Peripheral nerve injury of the treated extremity
- •Osteo- or rheumatoid-arthritis limiting range of motion
- •Contractures equal to or greater than 50% of the normal ROM
- •Skin condition not tolerant of device
- •Progressive neurodegenerative disorder
- •Botox treatment of the treated extremity in the prior 5 month
- •Chronic ITB therapy
- •Uncontrolled seizure disorder
- •Uncontrolled high blood pressure/angina
- •Pain in affected limb or exercise intolerance
研究组 & 干预措施
AMES treatment
The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.
干预措施: AMES treatment (Device)
结局指标
主要结局
Grasp Release Test
时间窗: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.
次要结局
- ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch(Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training)
- Capabilities of Upper Extremity Instrument(Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training)
- Strength Test - Thumb/Finger Extension(Prior to training (baseline), after each of 25 training sessions (about 3 times/week))
- ASIA Motor Key Muscles(Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training)
- ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick(Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training)
- Van Lieshout Hand Function Test for Tetraplegia- Short Version(Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training)
- Modified Ashworth Scale(Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training)
- Strength Test - Thumb/Fingers Flexion(Prior to training (baseline), after each of 25 training sessions (about 3 times/week))
- Strength Test - Wrist Extension(Prior to training (baseline), after each of 25 training sessions (about 3 times/week))
- Strength Test - Wrist Flexion(Prior to training (baseline), after each of 25 training sessions (about 3 times/week))
- Active Motion Test - Fingers/Thumb(Prior to training (baseline), after each of 25 training sessions (about 3 times/week))
- Active Motion Test - Wrist(Prior to training (baseline), after each of 25 training sessions (about 3 times/week))
研究者
Paul J. Cordo
Study Principal Investigator
Oregon Health and Science University