Shoulder Health After Rehabilitation and Performance Training (SHARP)

Swiss Paraplegic Research, Nottwil

Status: Not yet enrolling

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

Treatments: Other: Strength training

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT07245706

10.003.991 (Other Grant/Funding Number)

2025-16

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Early intervention

Experimental group

Description:

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

Treatment:

Other: Strength training

Late intervention

Experimental group

Description:

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

Treatment:

Other: Strength training