Long Term Effects of Soft Splints on Stroke Patients and Patients With Disorders of Consciousness
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in the Palm-finger distance
研究概览
简要总结
The purpose of this study is to assess the effects on upper limb spasticity of soft splints worn during three weeks three hours a day by patients with stroke or disorders of consciousness.
详细描述
Patients with stroke or disorders of consciousness (DOC) are likely to suffer from major muscular troubles such as spasticity. This spasticity may induce pain, loss in range of motion and permanent joint deformities. The aim of this study is to investigate the effects of soft splinting on the hand spasticity in both patients with stroke and patients with disorders of consciousness. The investigators plan to include 100 patients (50 stroke - 50 with DOC) and each subgroup will be divided in two arms: one wearing real soft splints (6 cm diameter) three hours a day for 3 three weeks and the other one wearing 'placebo' splints (1 cm diameter).
Skin condition will be followed by the nursing team during the three weeks. Spasticity, pain and consciousness assessments will be performed at baseline (week 0), after 1 week of treatment (week 1) at the end of the treatment (week 3), 1 week later (week 4), 3 weeks later (week 6) and three months later (week 12).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Altered state of consciousness according to international criteria since more than three months
- •Stable condition
- •Ashworth score > 1 for at least one upper limb joint
排除标准
- •Bone fracture/lesion at the upper limbs
- •Serious neurological disorder (MMSE > 24) prior to the accident
- •Botox injection on the upper limbs in the 6 months preceding the inclusion
- •Inclusion Criteria (stroke):
- •Central nervous system injury responsible for the spasticity
- •Ashworth score > 1 for at least one upper limb joint
- •Exclusion Criteria:
- •Bone fracture/lesion at the upper limbs
- •Serious neurological disorder (MMSE > 24)
- •Botox injection on the upper limbs in the 6 months preceding the inclusion
研究组 & 干预措施
DOC - real
Spastic patients with disorders of consciousness receiving the real soft splint
干预措施: Real soft splint (6 cm) (Device)
DOC - placebo
Spastic patients with disorders of consciousness receiving the placebo soft splint
干预措施: Placebo soft splint (1 cm) (Device)
Stroke - real
Spastic patients stroke receiving the real soft splint
干预措施: Real soft splint (6 cm) (Device)
Stroke - placebo
Spastic patients stroke receiving the placebo soft splint
干预措施: Placebo soft splint (1 cm) (Device)
结局指标
主要结局
Change in the Palm-finger distance
时间窗: Week 0, 1, 3, 4, 6, 12
Range of motion assessment
Change in the Modified Tardieu Scale
时间窗: Week 0, 1, 3, 4, 6, 12
Spasticity assessment
Change in the Visual Analogue Scale
时间窗: Week 0, 1, 3, 4, 6, 12
Pain assessment
Change in the Nociception Coma Scale-Revised
时间窗: Week 0, 1, 3, 4, 6, 12
Pain assessment
Change in the Modified Ashworth Scale
时间窗: Week 0, 1, 3, 4, 6, 12
Spasticity assessment
次要结局
- Change in the Coma Recovery Scale-Revised(Week 0, 1, 3, 4, 6, 12)
研究者
Géraldine Martens
PhD student
University of Liege