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Spinal Cord InjuriesNCT04422769

Needs of Persons with Spinal Cord Injury (SCI)

An observational study of Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than persons without spinal cord injury (SCI). They often experience a great deal of health needs both on a physiological level as well as a psychosocial level. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spinal Cord Injuries
How many people
53 participants
Where
1 siteUnited States
Study dates
22 May 2020to 15 Apr 2021
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: A sample of two hundred and fifty (n=250) persons with SCI will be recruited from the St. Louis, MO community. Many of these persons will be those who have participated in some of the investigators other research projects in the past. We also have collaborations with the Washington University Seating and Mobility Clinic and Paraquad, the local center for independent living.

Who may be able to join

  • diagnosis of an SCI; are 18 years or older; live in the community in the Greater St. Louis area, and have the ability to understand English.

Who cannot join

  • cognitive impairment that does not allow them to provide consent and/or ability to understand the questions posed in the survey

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: Tracking Needs of Persons with a Spinal Cord Injury (SCI) During the COVID-19 Pandemic

Persons with spinal cord injury (PwSCI) are at a greater risk for major health conditions and poorer health outcomes than persons without spinal cord injury (SCI). They often experience a great deal of health needs both on a physiological level as well as a psychosocial level. PwSCI frequently require supports and services to be able to live independently within the community. These services and supports are sometimes difficult to access within the community when the country is operating under regular capacity, in current times with the global COVID-19 pandemic, the challenges for obtaining and accessing supports and services will become much greater. The proposed project aims to identify the specific needs during this time of crisis and to provide referrals and resources to ameliorate those needs by surveying PwSCI in the St. Louis region. The project also hopes to determine if these persons experience isolation during shelter at home orders. PwSCI, who the investigators serve or have served in the past, will be contacted via phone or e-mail once a month for six months and asked to complete a questionnaire that will allow the investigators to track the participant's needs during the COVID-19 pandemic.

Read the detailed description

Acquiring a spinal cord injury (SCI) can be a traumatic event resulting in significant life changes. Both the physical and psychosocial consequences of spinal cord injury may negatively impact one's ability to accomplish activities of daily living, fully participate in occupations, and fulfill social roles. People with SCI are at a greater risk for major health conditions such as heart disease, high blood pressure, obesity, and diabetes than the population without disabilities. Approximately 30% of individuals with SCI are also at risk for developing negative mood states that include depression, anxiety, and anger. These negative mood states can also increase the risk of poor health outcomes, including increased medical complications, decreased independence in self-care, and decreased productivity. People with SCI also often require a great deal of supports and services to live independently within the community, such as a personal care attendant to assist with activities of daily living, access to accessible transportation, access to medical care, and access to repair services for their mobility device. Many of these supports and services are difficult to obtain in the community, medical institutions, and businesses when everything is operating in a regular capacity. With the changes in daily operations related to the COVID-19 pandemic there are many concerns about whether vulnerable populations like persons with SCI will be able to access the supports and services they need, this project will give the investigators information about what the needs are and whether they are being met.

Medical subject headings
Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NIH Toolbox Instrumental Support Survey - change in instrumental support

    Instrumental Support refers to the perception that people in one's social network are available to provide material or functional aid in completing daily tasks (such as making meals or providing transportation) if needed. This self-report measure for adults (ages 18 and above) is an 8-item calibrated scale.This study will use the measure to determine if people's instrumental support changes during a pandemic.

    Measured: Baseline, 3 month and 6 month

Secondary outcomes (1)

  1. UCLA (University of California - Los Angeles) 3-item Loneliness Scale - change in social isolation

    A scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. Participants rate each of the 3 items as hardly ever (score of "1"), some of the time (score of "2"), or often (score of "3"). The scores for each individual question can be added together to give you a possible range of scores from 3 to 9. The higher the score the more lonely the person will be. This study will use the measure to determine if people feel socially isolated during a pandemic.

    Measured: Baseline, 3 month and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start22 May 2020
  3. Primary completion15 Apr 2021
  4. Study completion15 Apr 2021

Resources

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
Cohort
Time perspective
Prospective
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04422769
Sponsor's protocol ID
202005026
Status last verified
May 2021
First submitted
4 Jun 2020
Last updated
28 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Adnana Y, Mckenzie A, Miyahara M. Self-efficacy for quad rugby skills and activities of daily living. Adapted Physical Activity Quarterly. 2001; 18: 90-101.

  • Blauwet C, Willick SE. The Paralympic Movement: using sports to promote health, disability rights, and social integration for athletes with disabilities. PM R. 2012 Nov;4(11):851-6. doi: 10.1016/j.pmrj.2012.08.015.

    PubMed 23174549

  • Slater D, Meade MA. Participation in recreation and sports for persons with spinal cord injury: review and recommendations. NeuroRehabilitation. 2004;19(2):121-9.

    PubMed 15201471

  • U.S. Department of Health and Human Services. (2000). Healthy people 2010: Understanding and improving health. 2nd ed. Washington, DC: U.S. Government Printing Office.

  • Jacobs PL, Beekhuizen KS. (2005). Appraisal of physiological fitness in persons with spinal cord injury. Topics in Spinal Cord Injury Rehabilitation, 10(4):32-50.

  • Keyser RE, Rasch EK, Finley M, Rodgers MM. Improved upper-body endurance following a 12-week home exercise program for manual wheelchair users. J Rehabil Res Dev. 2003 Nov-Dec;40(6):501-10. doi: 10.1682/jrrd.2003.11.0501.

    PubMed 15077662

  • Post MW, van Leeuwen CM. Psychosocial issues in spinal cord injury: a review. Spinal Cord. 2012 May;50(5):382-9. doi: 10.1038/sc.2011.182. Epub 2012 Jan 24.

    PubMed 22270190

  • Middleton J, Tran Y, Craig A. Relationship between quality of life and self-efficacy in persons with spinal cord injuries. Arch Phys Med Rehabil. 2007 Dec;88(12):1643-8. doi: 10.1016/j.apmr.2007.09.001.

    PubMed 18047880

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.

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 1 inclusion and 1 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 28 Mar 2025. 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 United States. 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?

NIH Toolbox Instrumental Support Survey - change in instrumental support (time frame: Baseline, 3 month and 6 month). 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 NCT04422769, which also lists 8 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 28 Mar 2025.

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Needs of Persons with Spinal Cord Injury (SCI) | AzTrials