Reliability and Validity Study to Assess the Test-retest and Intra-rater Reliability of SWE in Shoulder Muscles in Persons After Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- SWV m. infraspinatus
研究概览
简要总结
This study aims
- To examine the reliability of SWE assessment in the shoulder muscles of persons after a stroke.
- To assess if differentiation can be made between the hemiplegic (HP) and non-hemiplegic (NHP) side and between stroke patients and matched healthy volunteers (discriminative validity).
- To assess if an immediate effect on the pectoralis major and minor can be measured after applying transversal stretch technique to the pectoralis major muscles (response validity).
详细描述
Stroke patients will be assessed on 2 days with an interval of 3 days (Friday - Monday).
Day 1 (Friday): shear wave velocity (SWV) will be assessed by 2 assessors in randomised order. Each assessor will evaluate SWV of 6 shoulder muscles (m. supraspinatus, m. infraspinatus, m. rhomboid major, m. deltoideus, m. pectoralis major, m. pectoralis minor).
At the end of the assessment secondary outcome measures will be assessed.
Day 2 (Monday): SWV will be reassessed by assessor 1 to measure test-retest reliability.
Position of the patient will be changed. SWV of the pectoralis major and minor muscle will be reassessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- •Stroke group
- •Stroke patients in the subacute phase after stroke (< 6 months post stroke)
- •Able to sit independently with support of the back, but without support of the arms
- •With upper-limb (UL) impairment: i.e. no maximum score (36) on the shoulder elbow part of the Fugl-Meyer UL (FM UL)
排除标准
- •Other neurologic disorders
- •Shoulder or neck surgery before stroke onset
- •Arthroscopic surgery in the last year before stroke onset.
- •Shoulder or neck pain in the last year before stroke onset.
- •Severe cognitive or language deficits that inhibit the participants of understanding simple commands or providing valuable information regarding the outcome measures - measured with the Ability Q.
- •Participants who are not able to maintain the test position.
- •Pregnancy
- •Healthy controls can participate if they
- •Have not suffered a stroke or other neurological disorders
- •Did not have surgery at the shoulder and/or neck
- •Did not have arthroscopic surgery in the last year before stroke
- •If they do not suffer any shoulder or neck pain
研究组 & 干预措施
Stroke group
SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order.
- m. supraspinatus
- m. infraspinatus
- m. rhomboideus major
- m. deltoideus
- m. pectoralis major
- m. pectoralis minor
干预措施: SWE assessor 1 (Procedure)
Stroke group
SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order.
- m. supraspinatus
- m. infraspinatus
- m. rhomboideus major
- m. deltoideus
- m. pectoralis major
- m. pectoralis minor
干预措施: SWE assessor 2 (Procedure)
Stroke group
SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order.
- m. supraspinatus
- m. infraspinatus
- m. rhomboideus major
- m. deltoideus
- m. pectoralis major
- m. pectoralis minor
干预措施: Stretch intervention (Procedure)
Stroke group
SWE for 6 shoulder muscles will be performed by 2 assessors in randomised order.
- m. supraspinatus
- m. infraspinatus
- m. rhomboideus major
- m. deltoideus
- m. pectoralis major
- m. pectoralis minor
干预措施: No stretch intervention (Procedure)
Healthy controls
SWE for 6 shoulder muscles will be performed by 1 assessors.
- m. supraspinatus
- m. infraspinatus
- m. rhomboideus major
- m. deltoideus
- m. pectoralis major
- m. pectoralis minor
干预措施: SWE assessor 1 (Procedure)
结局指标
主要结局
SWV m. infraspinatus
时间窗: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. infraspinatus
SWV m. pectoralis major
时间窗: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. pectoralis major
SWV m. supraspinatus
时间窗: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. supraspinatus
SWV m. deltoideus
时间窗: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. deltoideus
SWV m. pectoralis minor
时间窗: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. pectoralis minor
SWV m. rhomboideus major
时间窗: Single point of assessment on day 2 (retest)
Shear wave velocity of the m. rhomboideus major
SWV m. supraspinatus
时间窗: Single point of assessment on day 1 (test)
Shear wave velocity of the m. supraspinatus
SWV m. infraspinatus
时间窗: Single point of assessment on day 1 (test)
Shear wave velocity of the m. infraspinatus
SWV m. rhomboideus major
时间窗: Single point of assessment on day 1 (test)
Shear wave velocity of the m. rhomboideus major
SWV m. pectoralis minor
时间窗: Single point of assessment on day 1 (test)
Shear wave velocity of the m. pectoralis minor
SWV m. deltoideus
时间窗: Single point of assessment on day 1 (test)
Shear wave velocity of the m. deltoideus
SWV m. pectoralis major
时间窗: Single point of assessment on day 1 (test)
Shear wave velocity of the m. pectoralis major
次要结局
- Sports before stroke(Assessment day 1)
- Passive range of motion of shoulder(Baseline assessment day 1)
- Spasticity shoulder muscles(Assessment day 1)
- Shoulder subluxation - ultrasound measurement(Assessment day 1)
- Subjective feeling of shoulder stiffness(Assessment day 1)
- Demographic variables(Baseline assessment day 1)
- Fugl-Meyer assessment upper limb section(Assessment day 1)