Spinal Cord InjurySHARPNCT07245706
Shoulder Health After Rehabilitation and Performance Training
A study testing Strength training in people with Spinal Cord Injury and Nervous System Diseases, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Nervous System Diseases, Musculoskeletal Diseases
- What is being tested?
- Strength training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 16 Jul 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons with a paraplegia below T2
- Manual wheelchair user
- Age 18 - 70 years
- At discharge from initial rehabilitation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Ensuring Shoulder Health as a Key Factor for Long Term Health and Functioning of Manual Wheelchair Users
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.
Read more
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.
- Being tested
- Strength training
- Keywords
- Shoulder, Wheelchair, Training, Activity of Daily Life, Load, Capacity, Functioning, Monitoring
- Medical subject headings
- Spinal Cord Injuries, Nervous System Diseases, Musculoskeletal Diseases, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength trainingOther
Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Experimental | This group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury Receives: Other: Strength training |
| Late intervention | Experimental | This group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury Receives: Other: Strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and after the training intervention (3 months apart)
Secondary outcomes (16)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start16 Jul 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245706
- Sponsor's protocol ID
- 2025-16
- Other IDs
- 10.003.991
- Acronym
- SHARP
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensuring Shoulder Health as a Key Factor for Long Term Health and Functioning of Manual Wheelchair Users
- ClinicalTrials.gov ID
- NCT07245706
- Acronym / sponsor ID
- SHARP / 2025-16
- Keywords
- Shoulder, Wheelchair, Training, Activity of Daily Life, Load, Capacity, Functioning, Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Swiss National Science Foundation
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early intervention | Experimental | Other: Strength trainingThis group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury |
| Late intervention | Experimental | Other: Strength trainingThis group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons with a paraplegia below T2
- Manual wheelchair user
- Age 18 - 70 years
- At discharge from initial rehabilitation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength trainingIndividualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks | Other | Early intervention, Late intervention |
Primary outcome
change in experienced shoulder pain during activities of daily life
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.
16 secondary outcomes
Experienced shoulder pain during activities of daily life
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Painful events
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder strength
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder range of motion
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder stability
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Heart rate during daily life
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Wheelchair use during daily life
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
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
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each
Shoulder pathology
Time frame: 3, 6, 12 and 15 months after discharge
Shoulder muscle volume
Time frame: 3, 6, 12 and 15 months after discharge
Shoulder muscle quality
Time frame: 3, 6, 12 and 15 months after discharge
Independence during daily life
Time frame: 3, 6, 12 and 15 months after discharge
Participation
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
General quality of life
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Physical activity
Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength training in people with Spinal Cord Injury and Nervous System Diseases, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ursina Arnet (+41419396599, ursina.arnet@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in experienced shoulder pain during activities of daily life (time frame: Before and after the training intervention (3 months apart)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.