Ensuring Shoulder Health as a Key Factor for Long Term Health and Functioning of Manual Wheelchair Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change in experienced shoulder pain during activities of daily life
研究概览
简要总结
The goal of this study is to investigate the impact of a home-based shoulder strength training on the overall shoulder health in manual wheelchair users, and if the timepoint of such a training makes a difference. The study is focusing on persons with a spinal cord injury in the thoracic or lumbar region of the spine, that have only recently been injured and will soon be discharged from primary rehabilitation.
The shoulder training will take place either 3 or 12 months after discharge from primary rehabilitation and will be carried out twice a week for 12 weeks.
There are six measurements occurring every three months, which leads to an overall duration of 15 months. The measurements consist of:
- Questionnaires about independence in daily life, participation, quality of life and physical activity
- Assessment of shoulder strength, range of motion and function
- Measurement of the daily wheelchair use during one week via sensors that are fixed to the wheelchair and wrist
- one further questionnaire at the end of the measurement week about the occurrence of shoulder pain
Additionally, on four of the six measurement timepoints, a magnet resonance image (MRI) of the shoulder will be taken to assess the shoulder status (pathology, muscle volume and quality).
Though all these measurements the researchers can additionally assess the load of daily life on the shoulders, and how well this matches the preparation during the primary rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The general radiologist who assesses the MRI images will be masked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with a paraplegia below T2
- •Manual wheelchair user
- •Age 18 - 70 years
- •At discharge from initial rehabilitation
排除标准
- •Trauma or surgery of the shoulder with medical indication for immobilization of more than four weeks
- •Constant use of power assistance for the wheelchair
- •Any surgical implants that exclude the participant for MRI assessments of the shoulder
- •Inability to follow the study instructions, e.g., mental health problems, language problems, dementia, claustrophobia (for MRI) etc.
- •Persons with congenital conditions leading to SCI, SCI in the context of palliative care, neurodegenerative disorders, and Guillain-Barré syndrome
- •Pregnancy
研究组 & 干预措施
Early intervention
This group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury
干预措施: Strength training (Other)
Late intervention
This group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury
干预措施: Strength training (Other)
结局指标
主要结局
change in experienced shoulder pain during activities of daily life
时间窗: Before and after the training intervention (3 months apart)
Expressed by the Wheelchair User's Shoulder Pain Index (WUSPI) score, a validated 15-item self-report instrument measuring shoulder pain during activities of daily life. For each activity, the shoulder pain experienced during the preceding week (corresponding to the week of monitoring of external exposure) is scored using a Visual Analog Scale (0-10). Total index scores can range from zero to 150 with zero meaning no pain and 150 maximal possible pain.
次要结局
- Experienced shoulder pain during activities of daily life(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Painful events(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Shoulder strength(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Shoulder range of motion(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Shoulder stability(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Heart rate during daily life(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Wheelchair use during daily life(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each)
- Shoulder loading acivities of daily life(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each)
- Shoulder load during activities of daily life(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each)
- Shoulder pathology(3, 6, 12 and 15 months after discharge)
- Shoulder muscle volume(3, 6, 12 and 15 months after discharge)
- Shoulder muscle quality(3, 6, 12 and 15 months after discharge)
- Independence during daily life(3, 6, 12 and 15 months after discharge)
- Participation(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- General quality of life(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)
- Physical activity(Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge)