The CIVIC pilot trial: Community-based intervention to prevent serious complications following spinal cord injury in Bangladesh

Phase 2

Completed

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

• Registration Number: ACTRN12613001137785
• Lead Sponsor: Centre for Rehabilitation of the Paralysed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. inpatient at the Centre for Rehabilitation of the Paralysed, Bangladesh about to be discharged.
2. sustained a traumatic or non-traumatic Spinal Cord Injury within the last 2 years.
3. aged 18 years or over at the time of consent.
4. requires a wheelchair for mobility on a daily basis

Exclusion Criteria

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

Secondary Outcome Measures

Name	Time	Method
Spinal Cord Injury Secondary Conditions Scale[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 recall the number of days in the last week in which they have got out of bed.[2 years];Out of house measure. Participants will be asked to recall the number of days in the last week in which they have gone out of the bounds of their home.[2 years];Work activities. Participants will be asked to report the number of days in the preceding week in which they engaged in work activities.[2 years];Prevalence of pressure ulcers, assessed by physical examination (inspection of the skin).[2 years]