Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207, Switzerland
Location status: Recruiting
NCT Number: NCT07245706
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Nottwil, Canton of Lucerne, 6207, Switzerland
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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:
Rated as painful, weak, negative, or not possible
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
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, 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: During the 12 weeks training intervention, after each session
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
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
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
Contact information is provided by the study sponsor or research team.
Swiss Paraplegic Research, Nottwil
Network
Ensuring Shoulder Health as a Key Factor for Long Term Health and Functioning of Manual Wheelchair Users
Acronym: SHARP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04460872
Androgen Deficiency, Bone Diseases
Gainesville, Florida, United States
View Trial DetailsNCT02325414
Acute Spinal Cord Injury, Bone Diseases
Chicago, Illinois, United States
View Trial DetailsNCT02025179
Bone Diseases, Bone Diseases, Metabolic
Chicago, Illinois, United States
View Trial DetailsNCT02195895
Bone Diseases, Bone Diseases, Metabolic
Chicago, Illinois, United States
View Trial Details