Injury, Musculoskeletal Diseases, Nervous System Diseases, Spinal Cord Injury
Conditions
Keywords
Shoulder, Wheelchair, Training, Activity of Daily Life, Load, Capacity, Functioning, Monitoring
Brief summary
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.
Interventions
OTHERStrength training
Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks
Sponsors
Swiss Paraplegic Research, Nottwil
Swiss National Science Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The general radiologist who assesses the MRI images will be masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Persons with a paraplegia below T2 * Manual wheelchair user * Age 18 - 70 years * At discharge from initial rehabilitation
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in experienced shoulder pain during activities of daily life | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Experienced shoulder pain during activities of daily life | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | 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. |
| Painful events | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | Specific events that resulted in shoulder pain during the measurement week |
| Shoulder strength | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | excerted peak force during six shoulder movements (abduction, adduction, flexion, extension, internal rotation, and external rotation), measured with a force sensor |
| Shoulder range of motion | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | active and passive range of motion of six shoulder movements (abduction, adduction, flexion, extension, internal rotation, and external rotation), measured with a goniometer |
| Shoulder stability | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | Assessed with clinical tests (provocative testing); Aggregated tests against resistance in eight different positions: * Full can test * Empty can test * Gerber's Lift off test * Neer's Test * Hawkins-Kennedy Test * Yergason's Test * Crank's Test * Belly-Press Test Rated as painful, weak, negative, or not possible |
| Heart rate during daily life | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | variation over the day, assessed by a wrist sensor |
| Wheelchair use during daily life | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each | Quantified by characteristics such as distance covered, number of pushes and turns or propulsion on an incline, measured by inertial measurement units (IMUs) |
| 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 | Classified by a machine learning algorithm including wheelchair propulsion, weight relief lift, manual material handling, transfer and deskwork, measured by inertial measurement units (IMUs) and a wheelchair cushion pressure mat |
| 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 | Total shoulder load calculated based on the frequency and duration of the activities and the shoulder load related to these activities |
| Shoulder pathology | 3, 6, 12 and 15 months after discharge | Grading of MRI abnormalities of rotator cuff tendons including tendinopathy and tendon tears and determination of Total Tendon Score (range 0-40) |
| Shoulder muscle volume | 3, 6, 12 and 15 months after discharge | Quantification of the muscle volume of the rotator cuff by deep-learning-based segmentation of the MRI |
| Shoulder muscle quality | 3, 6, 12 and 15 months after discharge | Quantification of fatty infiltration (fat fraction) of the rotator cuff by deep-learning-based segmentation of the MRI |
| Independence during daily life | 3, 6, 12 and 15 months after discharge | Quantified by the Self Report Spinal Cord Independence Measure (SR-SCIM)., a valid 17-item self-report instrument measuring independence in the domains of self-care, respiration and sphincter management and mobility. Total index scores can range from zero to 100. |
| Participation | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | Assessed with the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P), a valid 31-item instrument measuring participation in the domains of frequency, restrictions and satisfaction |
| General quality of life | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | Quantified by the 12-Item Short Form Survey (SF-12), a self-reported outcome measure assessing the impact of health on an individual's everyday life. Total scores can range from zero to 100 |
| Physical activity | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge | Assessed by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD), a 13-item questionnaire assessing physical activity over the preceding week in the domains of leisure, household and occupational activity. Scores are quantified in Metabolic Equivalents (METS h/day) and range from 0 (no activity) to over 100 METS h/day (very high) |
Countries
Switzerland
Contacts
CONTACTDr. Ursina Arnet
Outcome results
None listed