Effectiveness of Upper Limb Rehabilitation Using the Powerball System in People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Isometric pincer force
研究概览
简要总结
There is a high percentage of impairment in the upper limbs (UL) in patients with multiple sclerosis (MS), being muscle strength and hand dexterity a determining factor for the preservation of functional activities, constituting the basis of independence and quality of life. The aim of this study is to determine the effects of a training protocol on UL muscle strength, through the NDS-Powerball® system, in combination with conventional physiotherapy, during 8 weeks in terms of muscle strength, coordination, fatigue, functionality and quality of life in people with MS.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 20 and 60 years
- •Diagnosed with MS according to McDonald criteria with an evolution time of more than two years
- •Evaluation in the Kurtzke Disability Status Scale in Multiple Sclerosis (EDSS) with a score between 3.5 and 6
- •Score less than or equal to 4 on the "Pyramidal Function" section of the EDSS functional scale
- •Stable medical treatment for at least six months prior to surgery
- •Muscle tone in the upper extremities no greater than 2 points on the modified Ashworth scale.
- •Muscle balance equal to or greater than 3 in the upper extremity
- •Absence of cognitive impairment with ability to understand instructions and score equal to or greater than 4 on the Minimental Test.
排除标准
- •Diagnosis of another neurological disease or musculoskeletal alteration other than MS
- •Diagnosis of any cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study
- •Having suffered an exacerbation or hospitalization in the last three months before starting the assessment protocol, or during the therapeutic intervention process.
- •Having received treatment with botulinum toxin in the six months prior to the start of the study
- •Presence of visual alterations not corrected by means of ocular devices.
结局指标
主要结局
Isometric pincer force
时间窗: 3 minutes
A Baseline Pinch Gauge® was used to assess pinch force. Three presses were performed with the maximum possible force for 3 seconds, alternating between the dominant and non-dominant hand; the force obtained is marked in kilograms by the dynamometer. Once the 3 results were obtained, the average of these was obtained.
Isometric hand strength:
时间窗: 1 minute
Measured through the JAMAR® fist dynamometer, which is a sealed hydraulic system with an adjustable space to adapt to the handgrip of each patient. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of handgrip strength. In turn, its test-retest and inter-rater reliability is excellent in different populations. The patient held the tool with the upper limb at 0º of abduction and rotation; elbow flexed at 90º and the forearm in neutral position; wrist between 0 and 15º of radial deviation; and performed a maximum grip for 3 seconds with his 5 fingers, quantifying the force exerted in kilograms. Three measurements were taken with each hand, always starting with the dominant hand; once the three measurements were taken, the mean of these was used.
次要结局
- Fatigue Severity Scale (FSS)(2 minutes)
- Likert satisfaction questionnaire for the experimental group(1 minute)
- Box and Block Test (BBT)(3 minutes)
- Abilhand test(3 minutes)
- Nine Hole Peg Test (NHPT)(2 minutes)
- Multiple Sclerosis Impact Scale (MSIS-29)(3 minutes)
- Customer Satisfaction Questionnaire (CSQ8)(2 minutes)
研究者
Josue Fernandez Carnero
Principal Investigator
Universidad Rey Juan Carlos