An interventional study of Strength training in Spinal Cord Injury, Nervous System Diseases and Musculoskeletal Diseases, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Prevention
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:
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.
Exclusion Criteria:
This group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury
Other: Strength training
This group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury
Other: Strength training
Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks
change in experienced shoulder pain during activities of daily life
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.
Time frame: Before and after the training intervention (3 months apart)
Experienced shoulder pain during activities of daily life
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.
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Painful events
Specific events that resulted in shoulder pain during the measurement week
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder strength
excerted peak force during six shoulder movements (abduction, adduction, flexion, extension, internal rotation, and external rotation), measured with a force sensor
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder range of motion
active and passive range of motion of six shoulder movements (abduction, adduction, flexion, extension, internal rotation, and external rotation), measured with a goniometer
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder stability
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
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Heart rate during daily life
variation over the day, assessed by a wrist sensor
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Wheelchair use during daily life
Quantified by characteristics such as distance covered, number of pushes and turns or propulsion on an incline, measured by inertial measurement units (IMUs)
Time frame: 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
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
Time frame: 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
Total shoulder load calculated based on the frequency and duration of the activities and the shoulder load related to these activities
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each
Shoulder pathology
Grading of MRI abnormalities of rotator cuff tendons including tendinopathy and tendon tears and determination of Total Tendon Score (range 0-40)
Time frame: 3, 6, 12 and 15 months after discharge
Shoulder muscle volume
Quantification of the muscle volume of the rotator cuff by deep-learning-based segmentation of the MRI
Time frame: 3, 6, 12 and 15 months after discharge
Shoulder muscle quality
Quantification of fatty infiltration (fat fraction) of the rotator cuff by deep-learning-based segmentation of the MRI
Time frame: 3, 6, 12 and 15 months after discharge
Independence during daily life
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.
Time frame: 3, 6, 12 and 15 months after discharge
Participation
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
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
General quality of life
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
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Physical activity
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)
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Training amount
Number of repetitions of each exercise of the shoulder training will be recorded via the PhysiApp
Time frame: During the 12 weeks training intervention, after each session
Training resistance
Resistance used (e.g. weight) during the shoulder training will be recorded via the PhysiApp
Time frame: During the 12 weeks training intervention, after each session
Training exhaustion
Exhaustion felt during the shoulder training will be recorded via the PhysiApp on a scale from one to ten, where ten is highest exhaustion possible
Time frame: During the 12 weeks training intervention, after each session
Plan to share: No
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Swiss Paraplegic Research, Nottwil