Technology-assisted Upper Extremity Rehabilitation in Subjects with Incomplete Cervical Spinal Cord Injury - Randomized Controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The aim of the study is to investigate the effects of 6 weeks of technological-assisted rehabilitation on function of upper extremity and hand in subjects with incomplete cervical spinal cord injury.
详细描述
In this crossover study, persons with motor incomplete cervical (C2-C8) spinal cord injury (AIS C-D) will be recruited from the Hospital District of Helsinki and Uusimaa. In the first period of the crossover study, other part of the participants will get technological-assisted upper extremity rehabilitation, while the other part of the participants continue their normal lives. The first period is followed by 4-week wash-out period. In the second period, roles of the participants will be switched. The rehabilitation phase lasts for 6 weeks with 3 weekly sessions, each therapy session including at least 30 minutes of technological-assisted upper extremity rehabilitation. Rehabilitation includes passive, active and resistance exercises, and will be carried out by using AMADEO, PABLO and/or DIEGO devices made by Tyromotion.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •incomplete motor spinal cord injury (AIS C-D)
- •injury level C2-C8
- •time since injury from 1 to 5 years
- •to be able to sit
- •motivation and ability to participate in intensive rehabilitation 3 times per week for 6 week period.
排除标准
- •participation in other exercise study or technological-assisted upper extremity study
- •unlikely completion of intervention and participation in follow up
- •injuries that prevent training
- •weak tolerance of intense training
- •severe joint movement restriction or instability
- •irreversible muscle contractures
- •grade 4 on Modified Ashworth Scale in glenohumeral, elbow, wrist and finger joints
- •recent significant forearm or hand injuries
- •memory disorder
- •orthopedic, rheumatic or neurological diseases (other than spinal cord injury) that prevent training
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: 6 weeks,16 weeks, and 6 months
Maximum score is 114 (on a scale from 0 to 114) as the higher score indicate better upper extremity functioning.
Goal Attainment Scaling (GAS)
时间窗: 6 weeks or 16 weeks
A method to evaluate rehabilitation effects. A 5-point scale ranging from -2 to 2. Zero represents expected level of performance after rehabilitation, +1 more than expected, and +2 much more than expected. Respectively, -1 means less than expected and -2 much less than expected.
次要结局
- American Spinal Injury Association - Upper Extremity Motor Scores (ASIA-UEMS)(6 weeks,16 weeks, and 6 months)
- Pinch strength(6 weeks,16 weeks, and 6 months)
- Grip strength(6 weeks,16 weeks, and 6 months)
- Upper extremity active range of motion(6 weeks,16 weeks, and 6 months)
- Spinal Cord Independence Measure - Self Report (SCIM-SR)(6 weeks,16 weeks, and 6 months)
研究者
Joonas Poutanen
Principal investigator
University of Helsinki