Spinal Cord Injuries Clinical Trial
Official title:
The Effect of a Wheelchair Propulsion-induced Fatigue Protocol on Biomechanical and Neuromuscular Risk Factors of Shoulder Pain in Persons With a Spinal Cord Injury Living in Switzerland: a Cross-sectional Study With a Repeated Measures Within Subject Design
NCT number | NCT03153033 |
Other study ID # | 2016-13 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2017 |
Est. completion date | August 7, 2018 |
Verified date | November 2023 |
Source | Swiss Paraplegic Research, Nottwil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
What are the implications of wheelchair propulsion-induced fatigue for the development of shoulder pain and how can this knowledge improve prevention programs? With this project, the "Shoulder Health and Mobility group" of the Swiss Paraplegic Research in Nottwil (Switzerland) wants to investigate how fatigue during wheelchair propulsion affects risk factors for shoulder pain of persons with a spinal cord injury (SCI). The investigators want to find out how the handrim wheelchair propulsion technique changes with fatigue and want to define persons who are susceptible to fatigue. Getting life back after a SCI will most likely occur with the help of a wheelchair, whether it is at the beginning of rehabilitation or throughout further life. Gaining back mobility and participation in social life is important, also because of the multiple positive effects of physical activity on person's health and self-esteem, preventing several chronic diseases. Therefore, it is needed to try to stay away from shoulder injuries. Since the shoulder is very mobile and thus unstable, the joint is at increased risk for injuries. This is reflected in the high amount of persons with a SCI having shoulder pain (between 30 to 70 %). Once pain or an injury occurred, it is hard to recover, as so far no effective treatment is available. Several factors as gender, weight, age, level and completeness of the SCI, movement patterns and muscle strength were found to be related with injury and pain. However, it is currently not well understood what exactly causes shoulder injuries. Handrim wheelchair propulsion is an inefficient mode of propulsion and asks a lot of demands to the upper body. Because of the inefficient movement and the shoulder being prone to injuries, wheelchair propulsion has a high chance of inducing shoulder injuries and pain. Propelling with a technique minimizing the loads on the shoulders and improving the capacity to perform these movements (as increasing muscle strength) is of utmost importance as these factors can be modified by training. Previous intervention programs have learned wheelchair users to propel with long and smooth strokes aiming to reduce the loads. Although someone might be aware of the recommended techniques and can apply them, propulsion technique might change with fatigue and could become less optimal. A similar phenomena happens for example in landing strategies from a jump. In a fresh state, persons will try to have a stable landing reducing the impact on the lower limbs. With fatigue, however, there will be a tendency to forget about the proper landing technique which on its turn can increase the risk of injuries. This was suggested to be one of the reasons why there is an increased prevalence of injuries towards the end of a game. So far, it is unclear how fatigue alters propulsion technique and how these changes are related with an increased risk of shoulder pain. Tis project aims to achieve the goals by investigating how very strenuous wheelchair propulsion (fatigue intervention) of 15 minutes alters the propulsion technique of 50 persons with a SCI. All participants will perform the fatigue protocol in the movement analysis lab at the Swiss Paraplegic Research. During the protocol, participants will be requested to perform as many 8 loops as possible with their wheelchairs, including starts, stops, and right and left turns. Before and after the protocol, movement patterns, muscle usage and loads during wheelchair propulsion and the characteristics of the shoulder muscle tendons during rest will be assessed. Furthermore, the person's characteristics, such as weight, age, gender, time since injury, injury level, health conditions, use of medication, muscle strength and activity levels will be assessed. All these factors might be associated with the susceptibility to fatigue. To answer our questions, we will first compare the propulsion technique (movement patterns, loads, and muscle usage) before and after the protocol to investigate the direct effect of fatigue. Secondly, we will investigate the association of negative changes in tendon appearance (which has been related to injury) with the changes in the propulsion technique to investigate the implications of acute changes that might increase the risk of injury. Finally we will run a model including all variables to determine which person's characteristics are associated with an increased susceptibility to fatigue. The results will be highly relevant as it will give answers about the content, the aims and the target population of prevention programs for shoulder injury, aiming to improve mobility, participation, and quality of life in persons with SCI.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 7, 2018 |
Est. primary completion date | August 7, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Healthy adults with non-progressive traumatic or non-traumatic SCI with permanent residence in Switzerland. - Diagnosed with a paraplegia (lesion level T2-L1) - At least 1 year post discharge from rehabilitation - Use a handrim wheelchair for daily use and no required support for moving around for more than 100m with the handrim wheelchair - Able to manually propel a wheelchair for at least 15 minutes continuously - German or French speaking Exclusion Criteria: - New SCI in context of palliative care - SCI due to congental conditions, neurodegenerative disorders, or Guillain-arré syndrome. - Upper extremity pain that limits their ability to propel the wheelchair - History of shoulder, elbow, or wrist fractures/dislocations that are still causing symptoms - History of cardiopulmonary problems that could be exacerbated by strenuous physical activity - The wheelchair has no quick release axle |
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Paraplegic Research | Nottwil | Luzern |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Research, Nottwil | Human Engineering Research Laboratories, University Ghent |
Switzerland,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | sex | This is the biological sex of the participant | 10 minutes | |
Other | Activity levels | will be defined with a valid questionnaire (Physical Activity Scale for Individuals with a Disability (PASIPD)) at the beginning of data-collection to reduce recall-bias. | 20 minutes | |
Other | Weight | Weight of the person will be defined as the weight of the participant and the wheelchair minus the weight of the wheelchair itself. | 15 minutes | |
Other | Sprint time | Duration of a 15 m overground wheelchair propulsion sprint test. | 2 hours | |
Other | Maximum power output | Maximum power output of an isometric push against resistance. | 2 hours | |
Other | Etiology of the spinal cord injury | The participant will be asked whether the spinal cord injury has a traumatic or non-traumatic etiology | 10 minutes | |
Other | Lesion level of the spinal cord injury | The participant will be asked for the lesion level of the spinal cord injury (e.g., Thoracic 7-8). | 10 minutes | |
Other | Completeness of the spinal cinjury | The participant will be asked whether the spinal cord injury is complete or incomplete. | 10 minutes | |
Other | Time since injury of the spinal cord injury | The time since injury will be calculated from the data of measurement and the date the spinal cord injury occurred. | 10 minutes | |
Other | Health condition spasticity | Spasticity in the upper extremities will be reported via questions that will be asked to the persons. | 10 minutes | |
Other | Health condition contractures | Contractures in the upper extremities will be reported via questions that will be asked to the persons. | 10 minutes | |
Primary | Echogenicity ratio of the biceps brachii tendon | This is the ratio of the tendon pixel grayscale and the muscle pixel grayscale of the muscle above the tendon. | 4 hours | |
Secondary | Shoulder load | Defined as the glenohumeral contact force (3D total force of the head of the humerus against the glenoid fossa). This outcome will be based on a computerized model that uses kinetic and kinematic data. An instrumented wheelchair wheel will provide the kinetic data. The kinematic data will be measured with an eight-camera infrared camera system, using passive markers. In wheelchair research, this is the most widely accepted way of collecting data, since it is non-invasive as well as accurate. | 4 hours | |
Secondary | Shoulder kinematics | The shoulder kinematics will be defined as the relative orientations of the bony segments of the shoulder (thorax, clavicle, scapula and humerus) in 3D. The calculations will be done in agreement with the ISB definitions. The data will be provided with an eight-camera infrared camera system, using reflective markers. | 4 hours | |
Secondary | Contact time | This is the amount of time that the hand spends on the push rim during a stroke of wheelchair propulsion. An instrumented wheelchair wheel will provide the kinetic data from which contact time can be calculated. | 4 hours | |
Secondary | Muscle activity patterns of the biceps brachii | Muscular activation of the biceps brachii will be identified during the push phase of treadmill wheelchair propulsion. | 4 hours | |
Secondary | Muscle activity patterns of the upper trapezius | Muscular activation of the upper trapezius will be identified during the push phase of treadmill wheelchair propulsion. | 4 hours | |
Secondary | Muscle activity patterns of the lower trapezius | Muscular activation of the lower trapezius will be identified during the push phase of treadmill wheelchair propulsion. | 4 hours | |
Secondary | Muscle activity patterns of the deltoideus | Muscular activation of the deltoideus will be identified during the push phase of treadmill wheelchair propulsion. | 4 hours | |
Secondary | Muscle activity patterns of the pectoralis major | Muscular activation of the pectoralis major will be identified during the push phase of treadmill wheelchair propulsion. | 4 hours |
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