Shoulder Health After Rehabilitation and Performance Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSwiss Paraplegic Research, Nottwil
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Persons with a paraplegia below T2
Manual wheelchair user
Age 18 - 70 years
At discharge from initial rehabilitation
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Strength training
Other interventionIndividualized, home-based strength trainig consisting of 6 ecxercises that will be carried out twice a week for 12 weeks
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Early interventionExperimental treatment 1 intervention
Group B: Late interventionExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Before and after the training intervention (3 months apart)Secondary outcomes
1
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.
Time frame
Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge2
Painful events
Specific events that resulted in shoulder pain during the measurement week
Time frame
Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge3
Shoulder strength
excerted peak force during six shoulder movements (abduction, adduction, flexion, extension, internal rotation, and external rotation), measured with a force sensor
Time frame
Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past discharge4
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
Time frame
Before discharge from primary rehabilitation, 3, 6, 9, 12 and 15 months past dischargeOther outcomes
1
Training amount
Number of repetitions of each exercise of the shoulder training will be recorded via the PhysiApp
Time frame
During the 12 weeks training intervention, after each session2
Training resistance
Resistance used (e.g. weight) during the shoulder training will be recorded via the PhysiApp
Time frame
During the 12 weeks training intervention, after each session3
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
Time frame
During the 12 weeks training intervention, after each sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Swiss Paraplegic Research, Nottwil
Lead sponsor
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov