Spinal Cord InjuriesNCT03153033
Fatigue Induced by Overground Wheelchair Propulsion in Persons With a Spinal Cord Injury: Upper Limb Saving or Straining?
An observational study of Spinal Cord Injuries and Fatigue; Muscle, Heart, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Fatigue; Muscle, Heart
- What is being tested?
- Fatigue protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2017to 7 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will investigate healthy individuals with a SCI. Suitable participants will be identified based on the SwiSCI community survey (EKNZ registration number 1008). Suitable persons will be selected based on age (18-65 years), lesion level of SCI (paraplegia), language (German and French), time since injury, and use of wheelchair for daily activities. These persons will be contacted by letter and asked whether they are interested in participating in the study. After initial screening, further selection will be done using a questionnaire and further contact will be done by either telephone, e-mail or written letter (participants preference).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Research
Nottwil, Canton of Lucerne, 6207
About this study
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
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.
Read more
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.
Read the detailed description
Background and rationale:
Wheelchairs are the most important assistive devices used by persons with a spinal cord injury (SCI). A Danish study reported for example that 83.5% of 236 persons used a manual wheelchair and 27% a powered wheelchair, some of which used both a manual and an electrical wheelchair. The repetitive nature of wheelchair propulsion in combination with the shoulder being prone to injuries results in a high prevalence of persons with a SCI having shoulder pain. Several factors have been associated with shoulder pain but exact pathways remain unclear. In order to improve injury prevention which would have a significant effect on shoulder pain, it is important to focus on biomechanical and neuromuscular risk factors modifiable by training. Fatigue could have a negative effect on propulsion mechanics further increasing the risk of injury. Previous studies have induced fatigue by interventions on a treadmill or with an ergometer. However, it is important to investigate functional fatigue, as the effect of fatigue is task dependent. To date there is no clear understanding of the effect of functional fatigue on biomechanical and neuromuscular risk factors in persons with SCI during wheelchair propulsion.
Objectives:
Main objective: What is the role of muscle fatigue in altering neuromusculoskeletal and movement body functions and structures related to shoulder pain in persons with SCI? Aim1: To define how muscle fatigue induced by wheelchair propulsion changes biomechanical and neuromuscular risk factors of shoulder injuries, leading to shoulder pain, in persons with SCI.
Aim 2: To evaluate how changes in propulsion biomechanics due to propulsion-induced fatigue are associated with changes in tendon appearance related to tendinopathy, in persons with SCI.
Aim 3: To identify predictor variables (e.g., activity levels and muscle strength) for persons with SCI who are susceptible to wheelchair propulsion-induced fatigue.
Study design: Repeated measures within subject design
For this study, 50 participants will be recruited via the Swiss Spinal Cord Injury Cohort study database. The number of 48 participants was calculated based on a sample-size estimation from a study investigating a high-intensity wheelchair propulsion activity that found that echogenicity ratio changed significantly from 1.97 ± 0.74 to 1.73 ± 0.56 (p=0.038) (after the intense wheelchair propulsion activity. To observe this change of 0.24 difference in echogenicity ratio of the biceps tendon at 80% statistical power and alpha=0.05, 48 participants are needed. In order to take into account drop-out and missing data 50 participants will be recruited. All participants will meet the defined inclusion criteria and excluded when meeting the exclusion criteria.
Data collection:
Participants will be tested during one session of four hours after they have read and signed the informed consent. During the testing session the following measurements will be performed:
Participant's characteristics and activity levels: Socio-demographic variables, injury characteristics, presence of contractures and spasticity will be defined with a general questionnaire. Furthermore, activity levels will be defined with the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD).
Participants weight will be measured.
Quantitative ultrasound pre-fatigue: Ultrasound measurements of the biceps brachii and supraspinatus tendon at rest will be collected with Quantitative Ultrasound Protocols (QUS). This technique has been used previously and has proven strong reliability and validity for measures of shoulder pain and tendinopathy. More specifically, for the biceps tendon longitudinal image, participants will be positioned with their non-dominant arm flexed 90˚ at the elbow and their wrist resting on the ipsilateral thigh. Images will be taken so that the fibres are aligned perpendicular to the transducer which optimises the quantification of fibre alignment and tendon thickness. In order to mark the skin location of the pre-fatigue measurement, a steel reference marker will be taped to the skin at the distal end of the transducer. The distinct interference pattern created by the marker at the top of the images is used to define the region of interest (ROI) upon which the computations are performed. For the supraspinatus transverse image, participants will be positioned with their non-dominant palm placed on the lower back, shoulder extended, and elbow flexed posteriorly. The steel marker is now taped to the skin at the proximal end of the transducer and the widest part of the tendon is imaged. The specific positions optimize image quality and repeatability of the imaging protocol. Furthermore, three consecutive measurements of the acromio-humeral distance of the non-dominant hand will be collected under an unloaded and loaded conditions (during push up in wheelchair, once without further instructions and once with the instruction of retracting the shoulders) as has been done previously.
The same trained investigator will perform all ultrasound measurements.
Maximum sprint and strength test: A 15m over ground sprint test will be performed to define anaerobic work capacity. Furthermore a maximum isometric forward push against resistance on the wheelchair will be performed to measure maximal strength.These tests have been used previously. During both tests, external forces will be collected at 100 Hz with the SmartWheel. The 15m sprint aims to define the anaerobic work capacity. The participants will be required to propel as fast as possible from one cone to another standing 15 meters apart which will result in an outcome of the maximum unilateral power output. For the isometric maximum push, the wheelchair with SmartWheel will be connected via a rope to a force transducer and a wall. The participant will be requested to push as hard as possible for 5 seconds with the hands on top of the handrim to measure the maximum applied force.
Wheelchair propulsion pre-fatigue: The participant will be requested to propel his/her wheelchair on the treadmill for two trials of 90 seconds at two power output conditions (intermediate and hard). During the trials, 3D kinematics of the upper extremity, 3D kinetics applied to the handrim of the wheelchair and muscle activation of muscles active during wheelchair propulsion will be collected.
Fatigue protocol: The figure 8 protocol (fatigue intervention) requires the participants to propel three times as many laps as possible for four minutes each. Every bout of four minutes is separated by 90 seconds of rest. Each lap consists of a right and left turn and two complete stops after half a lap. Measurements during the protocol include the Rate of Perceived Exertion (RPE) scale, heart rate, and propulsion kinetics.
Wheelchair propulsion and Quantitative ultrasound post-fatigue: The same measurements as in the pre-fatigue tests will be performed.
Statistical considerations:
Aim 1: To investigate the effect of muscle fatigue induced by wheelchair propulsion on biomechanical and neuromuscular risk factors of shoulder injuries, leading to shoulder pain, in persons with SCI.
Hypothesis 1: Muscle fatigue induced by wheelchair propulsion will result in significant changes in biomechanical and neuromuscular risk factors related to shoulder pathology.
Dependent variables of interest are stroke frequency, glenohumeral contact force, net joint moments, kinematic and normalised muscle forces during wheelchair propulsion, tendon appearance of the m. biceps brachii and m. supraspinatus, and acromio-humeral distance. A statistical parametric mapping (SPM) one way repeated measures ANOVA will be used to assess meaningful variations across time for each continuous variable during wheelchair propulsion (alpha=0.05).
Aim 2: To determine the relation between changes in propulsion biomechanics and changes in tendon appearance related to tendinopathy post-fatigue, in persons with SCI.
Hypothesis 2: There will be a positive association between changes in propulsion biomechanics and changes in tendon appearance of the m.biceps and m.supraspinatus when controlling for sex, level and completeness of injury, health conditions, range of motion and weight.
Independent variables will be changes in propulsion biomechanics that significantly changed after the fatigue protocol and dependent variables will include changes in tendon appearance of the m.biceps and m.supraspinatus. Covariates will be sex, level and completeness of injury, health conditions (spasticity and contractures), range of motion and weight. Multivariable linear regression analysis will be used to test the hypothesis
Aim 3: To investigate the relation of the susceptibility of fatigue and person's characteristics (activity levels and muscle strength), in persons with SCI.
Hypothesis 3: There will be a negative association between changes in propulsion biomechanics (including stroke frequency, scapular kinematics and glenohumeral contact force) and both activity levels and muscle strength, when controlling for sex, level and completeness of injury, health conditions (spasticity and contractures), range of motion and weight.
Independent variables will be propulsion biomechanics that significantly changed after the fatigue protocol and dependent variables will include physical activity levels and muscle strength. Covariates will be sex, level and completeness of injury, health conditions (spasticity and contractures), range of motion and weight. Multivariable linear regression analysis will be used to test the hypothesis.
- Conditions
- Spinal Cord Injuries, Fatigue; Muscle, Heart
- Being tested
- Fatigue protocol
- Keywords
- Wheelchair propulsion, Shoulder, Biomechanics
- Medical subject headings
- Spinal Cord Injuries, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fatigue protocolBehavioural
The figure 8 protocol (fatigue intervention) requires the participants to propel three times as many laps as possible for four minutes each with their wheelchair. The protocol has been developed and used previously. Every bout of four minutes is separated by 90 seconds of rest. Each lap consists of a right and left turn and two complete stops after half a lap. Measurements during the protocol include the Rate of Perceived Exertion (RPE) scale, heart rate, and propulsion kinetics.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours
Secondary outcomes (8)
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.
Measured: 4 hours
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.
Measured: 4 hours
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.
Measured: 4 hours
Muscle activity patterns of the biceps brachii
Muscular activation of the biceps brachii will be identified during the push phase of treadmill wheelchair propulsion.
Measured: 4 hours
Muscle activity patterns of the upper trapezius
Muscular activation of the upper trapezius will be identified during the push phase of treadmill wheelchair propulsion.
Measured: 4 hours
Muscle activity patterns of the lower trapezius
Muscular activation of the lower trapezius will be identified during the push phase of treadmill wheelchair propulsion.
Measured: 4 hours
Muscle activity patterns of the deltoideus
Muscular activation of the deltoideus will be identified during the push phase of treadmill wheelchair propulsion.
Measured: 4 hours
Muscle activity patterns of the pectoralis major
Muscular activation of the pectoralis major will be identified during the push phase of treadmill wheelchair propulsion.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2017
- Study start1 Apr 2017
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Collaborators
- Human Engineering Research Laboratories, University Ghent
- Responsible party
- Sponsor
- Investigators
- Fransiska Marie Bossuyt, Msc, Principal investigator, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03153033
- Sponsor's protocol ID
- 2016-13
- Status last verified
- Nov 2023
- First submitted
- 4 May 2017
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mackenzie TA, Bdaiwi AH, Herrington L, Cools A. Inter-rater Reliability of Real-Time Ultrasound to Measure Acromiohumeral Distance. PM R. 2016 Jul;8(7):629-34. doi: 10.1016/j.pmrj.2015.11.004. Epub 2015 Nov 19.
PubMed 26603199Collinger JL, Gagnon D, Jacobson J, Impink BG, Boninger ML. Reliability of quantitative ultrasound measures of the biceps and supraspinatus tendons. Acad Radiol. 2009 Nov;16(11):1424-32. doi: 10.1016/j.acra.2009.05.001. Epub 2009 Jul 10.
PubMed 19596592Biering-Sorensen F, Hansen RB, Biering-Sorensen J. Mobility aids and transport possibilities 10-45 years after spinal cord injury. Spinal Cord. 2004 Dec;42(12):699-706. doi: 10.1038/sj.sc.3101649.
PubMed 15289807Enoka RM, Duchateau J. Translating Fatigue to Human Performance. Med Sci Sports Exerc. 2016 Nov;48(11):2228-2238. doi: 10.1249/MSS.0000000000000929.
PubMed 27015386Collinger JL, Impink BG, Ozawa H, Boninger ML. Effect of an intense wheelchair propulsion task on quantitative ultrasound of shoulder tendons. PM R. 2010 Oct;2(10):920-5. doi: 10.1016/j.pmrj.2010.06.007.
PubMed 20970761van Drongelen S, Boninger ML, Impink BG, Khalaf T. Ultrasound imaging of acute biceps tendon changes after wheelchair sports. Arch Phys Med Rehabil. 2007 Mar;88(3):381-5. doi: 10.1016/j.apmr.2006.11.024.
PubMed 17321833van der Scheer JW, de Groot S, Tepper M, Gobets D, Veeger DH; ALLRISC group; van der Woude LH. Wheelchair-specific fitness of inactive people with long-term spinal cord injury. J Rehabil Med. 2015 Apr;47(4):330-7. doi: 10.2340/16501977-1934.
PubMed 25594246van der Helm FC. A finite element musculoskeletal model of the shoulder mechanism. J Biomech. 1994 May;27(5):551-69. doi: 10.1016/0021-9290(94)90065-5.
PubMed 8027090van der Helm FCT. A thee dimensional model of the shoulder and elbow. First conference of the international shoulder group. Shaker Publishers BV, Delft University of Technology, The Netherlands. 1997.
Minder U, Arnet U, Muller E, Boninger M, Bossuyt FM. Changes in neuromuscular activation, heart rate and rate of perceived exertion over the course of a wheelchair propulsion fatigue protocol. Front Physiol. 2023 Oct 18;14:1220969. doi: 10.3389/fphys.2023.1220969. eCollection 2023.
PubMed 37920802
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03153033
- Acronym / sponsor ID
- 2016-13
- Conditions
- Spinal Cord Injuries, Fatigue; Muscle, Heart
- Keywords
- Wheelchair propulsion, Shoulder, Biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Collaborators
- Human Engineering Research Laboratories, University Ghent
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 15 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and rationale:
Wheelchairs are the most important assistive devices used by persons with a spinal cord injury (SCI). A Danish study reported for example that 83.5% of 236 persons used a manual wheelchair and 27% a powered wheelchair, some of which used both a manual and an electrical wheelchair. The repetitive nature of wheelchair propulsion in combination with the shoulder being prone to injuries results in a high prevalence of persons with a SCI having shoulder pain. Several factors have been associated with shoulder pain but exact pathways remain unclear. In order to improve injury prevention which would have a significant effect on shoulder pain, it is important to focus on biomechanical and neuromuscular risk factors modifiable by training. Fatigue could have a negative effect on propulsion mechanics further increasing the risk of injury. Previous studies have induced fatigue by interventions on a treadmill or with an ergometer. However, it is important to investigate functional fatigue, as the effect of fatigue is task dependent. To date there is no clear understanding of the effect of functional fatigue on biomechanical and neuromuscular risk factors in persons with SCI during wheelchair propulsion.
Objectives:
Main objective: What is the role of muscle fatigue in altering neuromusculoskeletal and movement body functions and structures related to shoulder pain in persons with SCI? Aim1: To define how muscle fatigue induced by wheelchair propulsion changes biomechanical and neuromuscular risk factors of shoulder injuries, leading to shoulder pain, in persons with SCI.
Aim 2: To evaluate how changes in propulsion biomechanics due to propulsion-induced fatigue are associated with changes in tendon appearance related to tendinopathy, in persons with SCI.
Aim 3: To identify predictor variables (e.g., activity levels and muscle strength) for persons with SCI who are susceptible to wheelchair propulsion-induced fatigue.
Study design: Repeated measures within subject design
For this study, 50 participants will be recruited via the Swiss Spinal Cord Injury Cohort study database. The number of 48 participants was calculated based on a sample-size estimation from a study investigating a high-intensity wheelchair propulsion activity that found that echogenicity ratio changed significantly from 1.97 ± 0.74 to 1.73 ± 0.56 (p=0.038) (after the intense wheelchair propulsion activity. To observe this change of 0.24 difference in echogenicity ratio of the biceps tendon at 80% statistical power and alpha=0.05, 48 participants are needed. In order to take into account drop-out and missing data 50 participants will be recruited. All participants will meet the defined inclusion criteria and excluded when meeting the exclusion criteria.
Data collection:
Participants will be tested during one session of four hours after they have read and signed the informed consent. During the testing session the following measurements will be performed:
Participant's characteristics and activity levels: Socio-demographic variables, injury characteristics, presence of contractures and spasticity will be defined with a general questionnaire. Furthermore, activity levels will be defined with the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD).
Participants weight will be measured.
Quantitative ultrasound pre-fatigue: Ultrasound measurements of the biceps brachii and supraspinatus tendon at rest will be collected with Quantitative Ultrasound Protocols (QUS). This technique has been used previously and has proven strong reliability and validity for measures of shoulder pain and tendinopathy. More specifically, for the biceps tendon longitudinal image, participants will be positioned with their non-dominant arm flexed 90˚ at the elbow and their wrist resting on the ipsilateral thigh. Images will be taken so that the fibres are aligned perpendicular to the transducer which optimises the quantification of fibre alignment and tendon thickness. In order to mark the skin location of the pre-fatigue measurement, a steel reference marker will be taped to the skin at the distal end of the transducer. The distinct interference pattern created by the marker at the top of the images is used to define the region of interest (ROI) upon which the computations are performed. For the supraspinatus transverse image, participants will be positioned with their non-dominant palm placed on the lower back, shoulder extended, and elbow flexed posteriorly. The steel marker is now taped to the skin at the proximal end of the transducer and the widest part of the tendon is imaged. The specific positions optimize image quality and repeatability of the imaging protocol. Furthermore, three consecutive measurements of the acromio-humeral distance of the non-dominant hand will be collected under an unloaded and loaded conditions (during push up in wheelchair, once without further instructions and once with the instruction of retracting the shoulders) as has been done previously.
The same trained investigator will perform all ultrasound measurements.
Maximum sprint and strength test: A 15m over ground sprint test will be performed to define anaerobic work capacity. Furthermore a maximum isometric forward push against resistance on the wheelchair will be performed to measure maximal strength.These tests have been used previously. During both tests, external forces will be collected at 100 Hz with the SmartWheel. The 15m sprint aims to define the anaerobic work capacity. The participants will be required to propel as fast as possible from one cone to another standing 15 meters apart which will result in an outcome of the maximum unilateral power output. For the isometric maximum push, the wheelchair with SmartWheel will be connected via a rope to a force transducer and a wall. The participant will be requested to push as hard as possible for 5 seconds with the hands on top of the handrim to measure the maximum applied force.
Wheelchair propulsion pre-fatigue: The participant will be requested to propel his/her wheelchair on the treadmill for two trials of 90 seconds at two power output conditions (intermediate and hard). During the trials, 3D kinematics of the upper extremity, 3D kinetics applied to the handrim of the wheelchair and muscle activation of muscles active during wheelchair propulsion will be collected.
Fatigue protocol: The figure 8 protocol (fatigue intervention) requires the participants to propel three times as many laps as possible for four minutes each. Every bout of four minutes is separated by 90 seconds of rest. Each lap consists of a right and left turn and two complete stops after half a lap. Measurements during the protocol include the Rate of Perceived Exertion (RPE) scale, heart rate, and propulsion kinetics.
Wheelchair propulsion and Quantitative ultrasound post-fatigue: The same measurements as in the pre-fatigue tests will be performed.
Statistical considerations:
Aim 1: To investigate the effect of muscle fatigue induced by wheelchair propulsion on biomechanical and neuromuscular risk factors of shoulder injuries, leading to shoulder pain, in persons with SCI.
Hypothesis 1: Muscle fatigue induced by wheelchair propulsion will result in significant changes in biomechanical and neuromuscular risk factors related to shoulder pathology.
Dependent variables of interest are stroke frequency, glenohumeral contact force, net joint moments, kinematic and normalised muscle forces during wheelchair propulsion, tendon appearance of the m. biceps brachii and m. supraspinatus, and acromio-humeral distance. A statistical parametric mapping (SPM) one way repeated measures ANOVA will be used to assess meaningful variations across time for each continuous variable during wheelchair propulsion (alpha=0.05).
Aim 2: To determine the relation between changes in propulsion biomechanics and changes in tendon appearance related to tendinopathy post-fatigue, in persons with SCI.
Hypothesis 2: There will be a positive association between changes in propulsion biomechanics and changes in tendon appearance of the m.biceps and m.supraspinatus when controlling for sex, level and completeness of injury, health conditions, range of motion and weight.
Independent variables will be changes in propulsion biomechanics that significantly changed after the fatigue protocol and dependent variables will include changes in tendon appearance of the m.biceps and m.supraspinatus. Covariates will be sex, level and completeness of injury, health conditions (spasticity and contractures), range of motion and weight. Multivariable linear regression analysis will be used to test the hypothesis
Aim 3: To investigate the relation of the susceptibility of fatigue and person's characteristics (activity levels and muscle strength), in persons with SCI.
Hypothesis 3: There will be a negative association between changes in propulsion biomechanics (including stroke frequency, scapular kinematics and glenohumeral contact force) and both activity levels and muscle strength, when controlling for sex, level and completeness of injury, health conditions (spasticity and contractures), range of motion and weight.
Independent variables will be propulsion biomechanics that significantly changed after the fatigue protocol and dependent variables will include physical activity levels and muscle strength. Covariates will be sex, level and completeness of injury, health conditions (spasticity and contractures), range of motion and weight. Multivariable linear regression analysis will be used to test the hypothesis.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will investigate healthy individuals with a SCI. Suitable participants will be identified based on the SwiSCI community survey (EKNZ registration number 1008). Suitable persons will be selected based on age (18-65 years), lesion level of SCI (paraplegia), language (German and French), time since injury, and use of wheelchair for daily activities. These persons will be contacted by letter and asked whether they are interested in participating in the study. After initial screening, further selection will be done using a questionnaire and further contact will be done by either telephone, e-mail or written letter (participants preference).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigue protocolThe figure 8 protocol (fatigue intervention) requires the participants to propel three times as many laps as possible for four minutes each with their wheelchair. The protocol has been developed and used previously. Every bout of four minutes is separated by 90 seconds of rest. Each lap consists of a right and left turn and two complete stops after half a lap. Measurements during the protocol include the Rate of Perceived Exertion (RPE) scale, heart rate, and propulsion kinetics. | Behavioural | – |
Primary outcome
Echogenicity ratio of the biceps brachii tendon
Time frame: 4 hours
This is the ratio of the tendon pixel grayscale and the muscle pixel grayscale of the muscle above the tendon.
8 secondary outcomes
Shoulder load
Time frame: 4 hours
Shoulder kinematics
Time frame: 4 hours
Contact time
Time frame: 4 hours
Muscle activity patterns of the biceps brachii
Time frame: 4 hours
Muscle activity patterns of the upper trapezius
Time frame: 4 hours
Muscle activity patterns of the lower trapezius
Time frame: 4 hours
Muscle activity patterns of the deltoideus
Time frame: 4 hours
Muscle activity patterns of the pectoralis major
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 26603199Mackenzie TA, Bdaiwi AH, Herrington L, Cools A. Inter-rater Reliability of Real-Time Ultrasound to Measure Acromiohumeral Distance. PM R. 2016 Jul;8(7):629-34. doi: 10.1016/j.pmrj.2015.11.004. Epub 2015 Nov 19.
- Results publication: PubMed 19596592Collinger JL, Gagnon D, Jacobson J, Impink BG, Boninger ML. Reliability of quantitative ultrasound measures of the biceps and supraspinatus tendons. Acad Radiol. 2009 Nov;16(11):1424-32. doi: 10.1016/j.acra.2009.05.001. Epub 2009 Jul 10.
- Results publication: PubMed 15289807Biering-Sorensen F, Hansen RB, Biering-Sorensen J. Mobility aids and transport possibilities 10-45 years after spinal cord injury. Spinal Cord. 2004 Dec;42(12):699-706. doi: 10.1038/sj.sc.3101649.
- Results publication: PubMed 27015386Enoka RM, Duchateau J. Translating Fatigue to Human Performance. Med Sci Sports Exerc. 2016 Nov;48(11):2228-2238. doi: 10.1249/MSS.0000000000000929.
- Results publication: PubMed 20970761Collinger JL, Impink BG, Ozawa H, Boninger ML. Effect of an intense wheelchair propulsion task on quantitative ultrasound of shoulder tendons. PM R. 2010 Oct;2(10):920-5. doi: 10.1016/j.pmrj.2010.06.007.
- Results publication: PubMed 17321833van Drongelen S, Boninger ML, Impink BG, Khalaf T. Ultrasound imaging of acute biceps tendon changes after wheelchair sports. Arch Phys Med Rehabil. 2007 Mar;88(3):381-5. doi: 10.1016/j.apmr.2006.11.024.
- Results publication: PubMed 25594246van der Scheer JW, de Groot S, Tepper M, Gobets D, Veeger DH; ALLRISC group; van der Woude LH. Wheelchair-specific fitness of inactive people with long-term spinal cord injury. J Rehabil Med. 2015 Apr;47(4):330-7. doi: 10.2340/16501977-1934.
- Results publication: PubMed 8027090van der Helm FC. A finite element musculoskeletal model of the shoulder mechanism. J Biomech. 1994 May;27(5):551-69. doi: 10.1016/0021-9290(94)90065-5.
- Results publicationvan der Helm FCT. A thee dimensional model of the shoulder and elbow. First conference of the international shoulder group. Shaker Publishers BV, Delft University of Technology, The Netherlands. 1997.
- Derived from this study: PubMed 37920802Minder U, Arnet U, Muller E, Boninger M, Bossuyt FM. Changes in neuromuscular activation, heart rate and rate of perceived exertion over the course of a wheelchair propulsion fatigue protocol. Front Physiol. 2023 Oct 18;14:1220969. doi: 10.3389/fphys.2023.1220969. eCollection 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Spinal Cord Injuries
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fransiska Marie Bossuyt, Msc principal investigator
Swiss Paraplegic Research, Nottwil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries and Fatigue; Muscle, Heart, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echogenicity ratio of the biceps brachii tendon (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03153033, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.