EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Spinal Cord Independence Measure version III (SCIM III)
研究概览
简要总结
Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life.
The objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total.
Patients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage.
We shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
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
- •Age 18+ years.
- •The levels of C5 C6 Asia C/D would provide individuals with elbow and hand impairment and potentially functional shoulder movements. C7, C8 individuals could also benefit from the hand component of the device.
- •Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest potential for functional change.
- •Preservation of hand sensation as base for motor restoration.
- •Some sitting balance would give the best opportunity for the arm to be released for functional upper limb activity.
- •EMG (muscle activity) evidence of active finger flexion, extension and elbow flexion extension Grade 1-
- •Minimal or No community functional use of upper limb at start of trial.
- •Spasticity MAS 1-3/5.
排除标准
- 未提供
结局指标
主要结局
Spinal Cord Independence Measure version III (SCIM III)
时间窗: Change from baseline (week 1) at 12 weeks
assesses performance in activities of daily living and mobility for individuals with spinal cord injury
次要结局
- Canadian Occupational Performance Measure (COPM)(Change from baseline (week 1) at 6 weeks and 12 weeks)
- The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).(Change from baseline (week 1) at 6 weeks and 12 weeks)
- The modified Ashworth scale(Change from baseline (week 1) at 6 weeks and 12 weeks)
- Range of Motion(Change from baseline (week 1) at 6 weeks and 12 weeks)