The CIVIC TRIAL: a randomised trial of a community-based intervention to prevent serious complications following spinal cord injury in Bangladesh

Not Applicable

Completed

• Conditions: spinal cord injury; Neurological - Other neurological disorders; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12615000630516
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-17
• Study Completion: 2020-02-15
• Last Update Posted: 29 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 410

Inclusion Criteria

1. inpatient at the Centre for Rehabilitation of the Paralysed, Bangladesh, soon to be discharged.
2. sustained a traumatic or non-traumatic spinal cord injury in the last 2 years.
3. aged 15 years or over at the time of consent.
4. requires a wheelchair for mobility on a daily basis.

Exclusion Criteria

Moving to another country following discharge from the Centre for Rehabilitation of the Paralysed, Bangladesh.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All-cause mortality.<br>The date of death will be confirmed by interviewing next of kin<br>(Bangladesh does not have a death registry). Wherever possible<br>independent corroboration of the date of death will be obtained, for<br>example from local community leaders.[2 years]

Secondary Outcome Measures

Name	Time	Method
Work activities. Participants will be asked to report the number of days in the preceding week on which they engaged in work activities.[2 years];Spinal Cord Injury Secondary Conditions Scale[2 years];Prevalence of pressure ulcers, assessed by a physical examination.[2 years];Pressure Ulcer Scale for Healing (PUSH)[2 years];Center for Epidemiologic Studies Depression Scale[2 years];SF12 - Health Related Quality of Life[2 years];Spinal Cord Independence Measure[2 years];WHODAS – 2 – Participation Items[2 years];Out of bed measure. Participants will be asked to report the number of days in the preceding week on which they got out of bed.[2 years];Out of house measure. Participants will be asked to report the number of days in the preceding week on which they left the bounds of their home.[2 years]