AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
  • Swiss Paraplegic Research

    Nottwil, Canton of Lucerne, 6207

    Recruiting

Other trials in Switzerland

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 groups in NCT07245706
Study groupRoleWhat they receive
Early interventionExperimentalThis group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury
Receives: Other: Strength training
Late interventionExperimentalThis 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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.

  1. First posted24 Nov 2025
  2. Study start16 Jul 2026
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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)
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

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.

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