NCT07015099

Brief Summary

The aim of this study is to determine the prevalence of complications including PUs at time of admission to a regional spinal injury rehabilitation unit (MCSI), the relationship between wait time to admission for specialist SCI rehabilitation and complication n occurrence, neurological recovery, and length of stay. The hypothesis is that wait time to transfer from the acute hospital to the specialised SCI rehabilitation unit is associated with increased PU prevalence and other SCI complications, as well as poorer neurological recovery and increased length of stay.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 14, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 11, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 14, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

SCISpinal Cord InjuryDelayed admission

Outcome Measures

Primary Outcomes (1)

  • Relationship between wait time to admission and complications

    Descriptive statistics and hypothesis-testing methods will be used to analyse primary data. Central tendencies (arithmetic mean, median and frequencies) and measures of variability (standard deviation and interquartile ranges) will be obtained. To test the hypothesis of the difference in frequency (sex) and difference in arithmetic means (age), chi-squared test and t-test will be used respectively. Mann-Whitney U-test will be used to test the hypothesis of difference in wait time to transfer for specialist SCI rehabilitation. Multivariable linear and generalised linear regression will be undertaken to identify the potential predictors associated with complication risk, patient recovery and hospital stay from delayed admission to the MCSI rehabilitation centre.

    7 months

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be included if they were 18 years or older at the time of the injury and admitted to MCSI and had an SCI classified by the American Spinal Injury Association Impairment Scale (ASIA) A-D.

You may qualify if:

  • All eligible patients will be included, of both sexes.

You may not qualify if:

  • Patients younger than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital

Oswestry, Sy10 7AG, United Kingdom

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2025

First Posted

June 11, 2025

Study Start

July 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations