Shoulder Health After Rehabilitation and Performance Training

NCT07245706 | Not Yet Recruiting

• 2 other identifiers: 2025-1610.003.991
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Shoulder; Wheelchair; Training; Activity of Daily Life; Load; Capacity; Functioning; Monitoring

Outcome Measures

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.

  Before and after the training intervention (3 months apart)

Secondary Outcomes (16)

• Experienced shoulder pain during activities of daily life

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

• Painful events

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

• Shoulder strength

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

• Shoulder range of motion

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

• Shoulder stability

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

Other Outcomes (3)

• Training amount

  During the 12 weeks training intervention, after each session

• Training resistance

  During the 12 weeks training intervention, after each session

• Training exhaustion

  During the 12 weeks training intervention, after each session

Study Arms (2)

Early intervention

EXPERIMENTAL

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

Other: Strength training

Late intervention

EXPERIMENTAL

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

Other: Strength training

Interventions

Strength training OTHER

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

Early intervention; Late intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Nervous System Diseases; Musculoskeletal Diseases; Wounds and Injuries

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Dr. Ursina Arnet

CONTACT

+41419396599; ursina.arnet@paraplegie.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The general radiologist who assesses the MRI images will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: November 24, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)