Shoulder Health After Rehabilitation and Performance Training

NCT ID: NCT07245706

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-31
• Study Completion Date: 2029-12-31

Brief 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.

Conditions

Spinal Cord Injury; Nervous System Diseases; Musculoskeletal Diseases; Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Early intervention

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

Group Type: EXPERIMENTAL

Strength training

Intervention Type: OTHER

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

Late intervention

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

Group Type: EXPERIMENTAL

Strength training

Intervention Type: OTHER

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

Interventions

Strength training

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

Swiss Paraplegic Research, Nottwil

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, Switzerland

Countries

Switzerland

Central Contacts

Dr. Ursina Arnet

Role: CONTACT

ursina.arnet@paraplegie.ch

+41419396599

Other Identifiers

10.003.991

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2025-16

Identifier Type: -

Identifier Source: org_study_id