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| ID | Type | Description | Link |
|---|---|---|---|
| 10.003.991 | Other Grant/Funding Number | Swiss National Science Foundation (SNSF) |
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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early intervention | Experimental | This group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury |
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| Late intervention | Experimental | This group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strength training | Other | Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Before and after the training intervention (3 months apart) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Training amount | Number of repetitions of each exercise of the shoulder training will be recorded via the PhysiApp | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ursina Arnet | Contact | +41419396599 | ursina.arnet@paraplegie.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Paraplegic Research | Nottwil | Canton of Lucerne | 6207 | Switzerland |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D009422 | Nervous System Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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The general radiologist who assesses the MRI images will be masked.
| 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 | 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 | 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 | 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:
Rated as painful, weak, negative, or not possible | 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 | 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) | 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 | 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 | 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) | 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 | 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 | 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. | 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 | 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 | 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) | Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge |
| 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 | During the 12 weeks training intervention, after each session |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |