Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07245706

Shoulder Health After Rehabilitation and Performance Training

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons with a paraplegia below T2
  • Manual wheelchair user
  • Age 18 - 70 years
  • At discharge from initial rehabilitation

Exclusion criteria

  • 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

Treatment and study plan

Strength training

Other

Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks

Primary outcomes

  1. 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.

Secondary outcomes

  1. Experienced shoulder pain during activities of daily life

    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.

  2. Painful events

    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

  3. Shoulder strength

    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

  4. Shoulder range of motion

    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

  5. Shoulder stability

    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:

    • 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

  6. Heart rate during daily life

    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

  7. 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

    Quantified by characteristics such as distance covered, number of pushes and turns or propulsion on an incline, measured by inertial measurement units (IMUs)

  8. 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

    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

  9. 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

    Total shoulder load calculated based on the frequency and duration of the activities and the shoulder load related to these activities

  10. Shoulder pathology

    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)

  11. Shoulder muscle volume

    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

  12. Shoulder muscle quality

    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

  13. Independence during daily life

    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.

  14. Participation

    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

  15. General quality of life

    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

  16. Physical activity

    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)

Other outcomes

  1. Training amount

    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

  2. Training resistance

    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

  3. Training exhaustion

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Ursina Arnet

CONTACT

[email protected]

+41419396599

Sponsors and collaborators

Lead sponsor

Swiss Paraplegic Research, Nottwil

Network

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

Ensuring Shoulder Health as a Key Factor for Long Term Health and Functioning of Manual Wheelchair Users

Acronym: SHARP

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 24, 2025
Registry last updated
Jul 23, 2026

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.