NCT03153033

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2018

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.4 years

First QC Date

May 4, 2017

Last Update Submit

November 6, 2023

Conditions

Keywords

Wheelchair propulsionShoulderBiomechanics

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Shoulder load

    4 hours

  • Shoulder kinematics

    4 hours

  • Contact time

    4 hours

  • Muscle activity patterns of the biceps brachii

    4 hours

  • Muscle activity patterns of the upper trapezius

    4 hours

  • +3 more secondary outcomes

Other Outcomes (11)

  • sex

    10 minutes

  • Activity levels

    20 minutes

  • Weight

    15 minutes

  • +8 more other outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Paraplegic Research

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (10)

  • 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.

    PMID: 26603199BACKGROUND
  • Collinger 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.

  • Biering-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.

  • Enoka RM, Duchateau J. Translating Fatigue to Human Performance. Med Sci Sports Exerc. 2016 Nov;48(11):2228-2238. doi: 10.1249/MSS.0000000000000929.

  • Collinger 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.

  • van 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.

  • van 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.

  • van 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.

  • van 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.

    RESULT
  • 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.

MeSH Terms

Conditions

Spinal Cord InjuriesFatigue

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Fransiska Marie Bossuyt, Msc

    Swiss Paraplegic Research, Nottwil

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2017

First Posted

May 15, 2017

Study Start

April 1, 2017

Primary Completion

August 7, 2018

Study Completion

August 7, 2018

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations