A Comprehensive Assessment of Trunk, Scapula and Upper Limb in Neurological Patients. Reliability, Validity and Interrelatedness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- The Reaching performance scale (RPS)
研究概览
简要总结
The study aimed to provide insights in the coordination between trunk, shoulder and upper limb while reaching. Two main phases are present in this study:
In phase A: the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS (Persons with Multiple Sclerosis) and healthy controls.
- To investigate the test-retest reliability of the Clinical Scapular Protocol (ClinScaP) and the Reaching Performance Scale (RPS) in PwMS
- To investigate the discriminative of the ClinScaP between PwMS and healthy controls
- To investigate the discriminative of the RPS between PwMS and healthy controls
- To investigate the concurrent validity of ClinScaP and RPS in PwMS, compared with upper limb dysfunction measurements.
In phase B: 5. To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients. 6. To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for all participants: Healthy controls, PwMS (Persons with Multiple Sclerosis) and stroke patients
- •Age > 18 years
- •Able to understand and execute the test instructions
- •Able to sit on a chair with low back support for 10 minutes
- •Inclusion criteria specific for PwMS:
- •Diagnosed with MS (Multiple Sclerosis) using McDonald criteria
- •Able to move at least 1 out of 3 joints (wrist, elbow or shoulder): Medical Research Council score
- •Inclusion criteria for stroke patients:
- •First- ever single, unilateral (ischemic or hemorrhagic) stroke
- •No apraxia or hemi spatial neglect
- •Able to move at least 1 out of 3 joints of the affected upper limb (wrist, elbow or shoulder): Medical Research Council score 3.
排除标准
- •Other medical conditions interfering with the upper limb function or trunk (orthopedic or rheumatoid impairment)
- •Perceived pain in one of the upper limbs of more than 4/10 (Visual Analog Scale)
- •Severe cognitive or visual deficits interfering with testing
- •For the PwMS: a relapse or relapse-related treatment in the last month prior to the study
结局指标
主要结局
The Reaching performance scale (RPS)
时间窗: Day 1
The Reaching performance scale (RPS) evaluates 6 components during reaching to a cup. The first four components: 1. trunk displacement, 2. movement smoothness, 3. shoulder movements, and 4. elbow movements. The components are evaluated during reaching movements to targets placed close or far from the person. The 2 additional components globally rate 5. the quality of prehension and 6. the accomplishment of the task.
The clinical scapular protocol
时间窗: day 1
The clinical scapular protocol consists of five items. A score is given between 0 and 2, based on observation of tilting and winging, shoulder girdle position (measuring acromial and pectoralis minor index and scapular distance test), scapular lateral rotation, maximal active humeral elevation, medial rotation test
次要结局
- Box and Block test(day 1)
- The Action Research Arm Test (ARAT)(day 1)
- Trunk Impairment Scale(day 1)
- Modified Ashworth Scale(day 1)
- Maximal hand grip strength test (HGS)(Baseline)
- The Manual Ability Measure-36 (MAM-36)(day 1)
- Symbol digit modalities test(Day 1)
- Modified fatigue impact scale(Day 1)
- The Brunnström Fugl Meyer (BFM)(day 1)
- The Nine Hole Peg Test (NHPT)(day 1)
- Arm Function in Multiple Sclerosis Questionnaire(Day 1)
- Active and passive range of motion of shoulder, elbow and wrist movement(Day 1)
- Maximal hand grip strength HGS)(Day 1)
- National Institutes of Health Stroke Scale (NIHSS)(Day 1)
- 10 Meter loop test (10MWT)(Day 1)
- Modified Rankin Scale (MRS)(day 1)
研究者
Peter Feys
Principal Investigator
Hasselt University