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Recruiting NCT07245706

Shoulder Health After Rehabilitation and Performance Training

No phase Interventional Spinal Cord Injury Nervous System Diseases Musculoskeletal Diseases Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Strength training.
Who it may be relevant to
Registry conditions: Spinal Cord Injury, Nervous System Diseases, Musculoskeletal Diseases, Injury. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • change in experienced shoulder pain during activities of daily life [Time frame: Before and after the training intervention (3 months apart)]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Switzerland · 1 center
  • Swiss Paraplegic Research — Nottwil

Identifiers

NCT: NCT07245706 · 2025-16 · 10.003.991

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗