CClinicalTrials.gg
RecruitingNCT07245706SHARPUpdated Jul 23, 2026

Shoulder Health After Rehabilitation and Performance Training

An interventional study of Strength training in Spinal Cord Injury, Nervous System Diseases and Musculoskeletal Diseases, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Spinal Cord Injury
  • Nervous System Diseases
  • Musculoskeletal Diseases
  • Injury

Keywords

  • Shoulder
  • Wheelchair
  • Training
  • Activity of Daily Life
  • Load
  • Capacity
  • Functioning
  • Monitoring
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Early intervention

    This group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury

    Other: Strength training

  • Experimental
    Late intervention

    This group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury

    Other: Strength training

Interventions

  • OtherStrength training

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

05

What researchers measure

Primary outcomes

  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.

    Time frame: Before and after the training intervention (3 months apart)

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge

Other outcomes

  1. Training amount

    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

  2. Training resistance

    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

  3. 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

    Time frame: During the 12 weeks training intervention, after each session

06

Study locations

1 of 1 sites recruiting
  • Swiss Paraplegic Research
    Nottwil, Canton of Lucerne 6207, Switzerland
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07245706
Lead sponsor
Swiss Paraplegic Research, Nottwil
Collaborators
Swiss National Science Foundation
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Jul 16, 2026
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Jul 23, 2026

Study contacts

Dr. Ursina Arnet
Contact
ursina.arnet@paraplegie.ch
+41419396599

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion