Effects of a Dynamic Upper Limb Orthosis in Reducing Tremor and Rigidity on Patients With Parkinson's Disease: a Randomized Clinical Test Study Protocol
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rigidity of the upper limb
研究概览
简要总结
This is a randomized controlled clinical trial aimed at Parkinson's disease patients. Its objective is to evaluate the effects of a dynamic upper limb orthosis to achieve maximum hand functionality, reducing tremor and rigidity
详细描述
Objective
To assess the effect at 3 and 6 months of the upper limb orthosis, applied for 3 months in the functionality of the affected upper member, manual dexterity, performance of daily living activities and quality of life in Parkinson patients.
Design and setting: A randomized controlled clinical trial of two parallel groups.
Population: 40 patients with tremor and stiffness due to Parkinson´s disease will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the Burgos University Hospital (Spain)
. Measurements and intervention: Functionality of the affected upper member, manual dexterity, performance of daily living activities and health-related quality of life will be evaluated. All participants will continue to receive the medical treatment indicated to their health status. The intervention group will receive a treatment based on a dynamic orthosis during 3 months. No additional intervention with the participants of the control group will be completed.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Parkinson's disease according to "brain bank" criteria
- •Parkinson's disease stage 1 to 3 according to the Hoehn and Yahr scale
排除标准
- •Moderate cognitive or language impairment
- •Musculoskeletal or dermatological diseases in the upper limb
- •Impossibility of follow-up for 6 months
- •Difficulty to attend to assessment visits
- •Allergy to glove composition
结局指标
主要结局
Rigidity of the upper limb
时间窗: 3 months
Measurement by the Movement Disorders. Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - Subscale III Score between 0 (best functionality) and 68 (worst functionality)
Tremor of the upper limb
时间窗: 3 months
Measurement by the Kinesia One Device This device will provide information on the speed, amplitude and rhythm of the tremor of the upper limb. There are no minimum or maximum values
次要结局
- Emotional state and quality of life.(3 months)
- Manual dexterity of the upper limb(3 months)
- Daily Living Activities(3 months)