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OpenTrials
Completed

NCT Number: NCT04426071

The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Document and evaluate the impact of societal restrictions due to the pandemic on SCI- and ABI-related disability and functional impairments, and the resultant effects on psychological wellbeing, physical wellbeing and quality of life for those with SCI/ABI.

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Key information

Conditions

Brain Injuries Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Personal Satisfaction Psychological Well-Being Spinal Cord Diseases Spinal Cord Injuries Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lawson Health Research Institute

London, Ontario, N6C2R5, Canada

About this study

The investigators will conduct a longitudinal survey to examine the impact of COVID19 on those with SCI and ABI. An a priori sample size of 117 individuals based on an alpha level of .05 and level of acceptable error at 3% was calculated. Anticipating for loss to follow up rate of up to 20%, a total of 142 participants will be recruited. Patients will be recruited among those who attend virtual medical appointments at Parkwood Institute for ABI and SCI. We will also liaise with SCI-Ontario and the Ontario Brain Injury Association to assist in the recruitment of additional participants. Those who consent will complete an online survey on enrollment into the study, and subsequently at 3 and 6 months. Demographic data of the individuals participating in the study will be recorded. Participants' access to health care services will be evaluated using the following subdomains: medical care, complementary care, medications/equipment, satisfaction/acceptability, affordability, ability to engage, and indirect support.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • stroke, spinal cord injury (traumatic and non-traumatic) or acquired brain injury (of all severities, including concussion)
  • live in the community
  • have the cognitive capacity to understand and complete the measures

Exclusion criteria

  • does not have the cognitive capacity to understand and complete the measures
  • does not speak English

Treatment and study plan

Primary outcomes

  1. Change in Fear of COVID-19

    Time frame: baseline, 3 months, 6 months

    Fear of COVID-19 Questionnaire

Secondary outcomes

  1. Change in ability to participate in social roles and activities

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Ability to Part. in SRA

  2. Change in depressive symptoms

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Depression

  3. Change in positive affect and well-being

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Pos. Affect & Well-Being

  4. Change in anxiety

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Anxiety

  5. Change in fatigue

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Fatigue

  6. Change in emotional and behavioural dyscontrol

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Emotional & Beh. Dyscontrol

  7. Change in satisfaction with social roles and activities

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Satisfaction w SRA

  8. Change in sleep disturbance

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Sleep Disturbance

  9. Change in stigma

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Stigma

  10. Change in cognitive function

    Time frame: baseline, 3 months, 6 months

    NeuroQol SF v1.0 - Cognitive Function

  11. Change in social distancing strategies used

    Time frame: baseline, 3 months, 6 months

    23 questions about strategies to social distance

  12. Change in thoughts and feelings about social distancing

    Time frame: baseline, 3 months, 6 months

    22 questions about social distancing

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Official study title

COVID-19 and Disability: The Impact of a Societal Lockdown on Those With Spinal Cord and Brain Injuries

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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