Shoulder Health After Rehabilitation and Performance Training (SHARP)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nervous System Diseases; Musculoskeletal Diseases; Spinal Cord Injury; Injury
• Intervention / Treatment: Other: Strength training

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Ursina Arnet; Phone Number: +41419396599; Email: ursina.arnet@paraplegie.ch

Study Locations

• Switzerland
  • Canton of Lucerne
    • Nottwil, Canton of Lucerne, Switzerland, 6207
      • Swiss Paraplegic Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early intervention; This group starts the training program 3 months post discharge from primary rehabilitation after spinal cord injury	Other: Strength training; Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks
Experimental: Late intervention; This group starts the training program 12 months post discharge from primary rehabilitation after spinal cord injury	Other: Strength training; Individualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Painful events	Specific events that resulted in shoulder pain during the measurement week	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Shoulder strength	excerted peak force during six shoulder movements (abduction, adduction, flexion, extension, internal rotation, and external rotation), measured with a force sensor	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
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	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
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	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
Heart rate during daily life	variation over the day, assessed by a wrist sensor	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
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)	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	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	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	Total shoulder load calculated based on the frequency and duration of the activities and the shoulder load related to these activities	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge, measured for one week each
Shoulder pathology	Grading of MRI abnormalities of rotator cuff tendons including tendinopathy and tendon tears and determination of Total Tendon Score (range 0-40)	3, 6, 12 and 15 months after discharge
Shoulder muscle volume	Quantification of the muscle volume of the rotator cuff by deep-learning-based segmentation of the MRI	3, 6, 12 and 15 months after discharge
Shoulder muscle quality	Quantification of fatty infiltration (fat fraction) of the rotator cuff by deep-learning-based segmentation of the MRI	3, 6, 12 and 15 months after discharge
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.	3, 6, 12 and 15 months after discharge
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	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
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	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge
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)	Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Training amount	Number of repetitions of each exercise of the shoulder training will be recorded via the PhysiApp	During the 12 weeks training intervention, after each session
Training resistance	Resistance used (e.g. weight) during the shoulder training will be recorded via the PhysiApp	During the 12 weeks training intervention, after each session
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	During the 12 weeks training intervention, after each session

Collaborators and Investigators

• Sponsor: Swiss Paraplegic Research, Nottwil
• Collaborators: Swiss National Science Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 1, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Training; Monitoring; Shoulder; Functioning; Wheelchair; Capacity; Activity of Daily Life; Load
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries; Musculoskeletal Diseases; Nervous System Diseases; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Physical Therapy Modalities; Patient Care; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Physical Conditioning, Human; Exercise; Resistance Training
• Other Study ID Numbers: 2025-16 (Eskisehir Osmangazi University Scientific Research Projects Unit); 10.003.991 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No