Trinity College Dublin study on SCI

A junior doctor at Trinity College Dublin is currently conducting research on spinal cord injury as part of his masters degree and he is looking for participants who have a SCI to be involved with the study. The study focuses on the reliability of the International Standards for Neurological Classification of SCI using motor and sensory examinations. If you are living with a SCI in Ireland and would like to be involved with this study, read below for a more detailed explanation of what is involved in the study.

** Please note that the anorectal parts of the examination will NOT be performed as part of this study**

Participant Information Sheet

Study Title

The intrarater reliability of the International Standards for Neurological Classification of Spinal Cord Injury motor and sensory examinations in a cohort of people with spinal cord injury from Ireland.

Introduction

The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) and the American Spinal Injury Association (ASIA) Impairment Scale are considered the gold standard for spinal cord injury (SCI) classification. However, evidence shows that only a small number of studies have examined ISNCSCI reliability. Given the frequent use of this classification scale in both clinical practice and clinical trials it is important that its reliability is properly established. Our study aims to evaluate the reliability of the ISNCSCI.

Procedures

You will need to attend the exercise laboratory in Trinity College Dublin’s high-performance unit on two occasions (the duration of each visit will be approximately one to two hours). On both occasions, you will be met by the same medical professional (doctor) who is acting as lead investigator. During visit one you will:

  • Be familiarised with all procedures and have an opportunity to ask questions.
  • Be asked to sign a consent form.
  • Complete a medical questionnaire and undergo a preliminary general medical examination.
  • Undergo a full ISNCSCI examination (except for the voluntary anal contraction or deep anal pressure elements of the examination).

The ISNCSCI examination involves lying the participant flat on their back on a bed and testing the sensory and motor components of his/her neurological system. The sensory component of the examination involves the application of pinprick and light touch stimuli to areas of skin across the participant’s body to determine sensory levels for the right and left sides. The motor component involves testing the participant’s power in specific muscles in their upper and lower limbs to determine motor levels for the right and left sides.

During visit two you will:

  • Undergo a second full ISNCSCI examination.

Your ISNCSCI examination scores from the two visits will then be compared in order to calculate its reliability.

With your consent, we would like to contact your neuro rehabilitation specialist to obtain information on your formally documented ISNCSCI scores and your radiology reports detailing your SCI. This will enable comparisons to be made between ISNCSCI scores from our study and those from your neuro rehabilitation specialist, as well as comparisons to be made between ISNCSCI scores and radiological findings. We will not require access to your medical records.

Accessibility

The high-performance unit in TCD Watt’s building is readily accessible via public transport. Alternatively, as per the trinity disability service, disabled parking is available for all blue badge holders on campus (please enter via Lincoln Gate and ask staff on the day where the best place is to park nearest Watts building). The lab is on the second floor and has lift access.

Benefits

The potential benefits from participating in this study include:

  • Contribution to valuable research in the field of SCI. According to the world health organisation, between 250 000 and 500 000 people suffer SCI every year around the world. This high incidence demonstrates the need to have a SCI classification system that is robust. You have the opportunity to help develop this classification system further.
  • Having an up to date neurological assessment performed that will assess your SCI.
  • The opportunity to meet a friendly team of researchers in a world renowned educational establishment.

Risks

The risk of any adverse outcome is minimal, as all procedures undertaken in this study are non- invasive. You will be assessed while lying on your back on a couch and as such, the risk of injury (for example, due to falls) is very small.

Exclusion from participation

Inclusion in the study is open to all individuals aged 18-45 years of age. The spinal cord injury can be complete or incomplete (ASIA A-D). Both traumatic and atraumatic causes of the spinal cord injury will be included. Participants must have a stable medical condition. Unfortunately, you cannot participate in the study if you have any of the following:

  • Cardiopulmonary disease
  • Autonomic Dysreflexia
  • Painful musculoskeletal dysfunctions (for example, unhealed fracture, contracture, pressure sore)
  • Clinically significant depression
  • Drug abuse
  • Acute infection – Urinary tract infection, cellulitis, respiratory tract infection
  • Botox (Botulinum Toxin Type A) injections in the previous six months into lower limb muscles for spasticity
  • *Some medications may need to be withheld for greater than 12 hours prior to testing – If you are taking Diazepam or Baclofen we will time your test to be 12 hours from your last dose. Please can you inform us if you are on these medications.

Confidentiality

Your identity will remain confidential at all times. Your name will not be published and will not be disclosed to anyone outside the designated research group. All your data collected during the study will be stored on a computer in a secure location which only the primary investigators will have access to. The computer will be password protected and only the primary investigators will have access to the password. All your hard copy records will be kept in a secure storage place in the laboratory, which only the primary investigators will have access to. For additional security, your identity and data will be referenced under a study specific code number at all times. These security measures will stay in place during the study and after it has finished. Data will only be analysed in group format and no personal information or data relating to any participant will be disclosed. Your data will be kept for the duration of the study and until the work is fully reported and disseminated, and your data will then be kept in a locked cabinet for a further five years. If you withdraw from the study all your data held by the research team relating to the study will be destroyed.

Compensation

This study is covered by standard institutional indemnity insurance. Nothing in this document restricts or curtails your rights.

Study results

This study is being carried out to fulfil the requirement for thesis presentation as part of the MSc in Sports and Exercise Medicine at Trinity College Dublin. Therefore, results will be presented in thesis format. At a later stage, they may be presented at conferences or as a journal paper. At all times, your identity will remain confidential as described above. Raw data and results will be kept for five years post-study to comply with university requirements before being securely destroyed.

Voluntary Participation

You are not under any obligation to volunteer for this proposed study. If you do wish to take part you are free to subsequently withdraw at any stage.

Stopping the study

You understand that the investigators may withdraw your participation in the study at any time without your consent.

Permission

This study has been reviewed and received ethics clearance by the Faculty of Health Sciences Research Ethics Committee at Trinity College Dublin. If you have any further questions, you can get more information or answers to your questions about the study, your participation in the study, and your rights, from the contacts below. If the study team learns of important new information that might affect your desire to remain in the study, you will be informed at once.

IF YOU ARE CONSIDERING TAKING PART IN THE STUDY OR REQUIRE FURTHER INFORMATION PLEASE CONTACT:

Dr Paul van der Westhuizen

Email: vanderwp@tcd.ie

It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form.

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