scholarly journals A community-based intervention to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh (CIVIC): a randomised trial

Spinal Cord ◽  
2020 ◽  
Author(s):  
Mohammad Sohrab Hossain ◽  
Lisa A. Harvey ◽  
Md. Shofiqul Islam ◽  
Md. Akhlasur Rahman ◽  
Stephen Muldoon ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Community Based ◽  
Phone Calls ◽  
Cord Injury ◽  
Randomised Controlled

Abstract Study design Randomised controlled trial. Objectives To determine the effectiveness of a sustainable community-based intervention designed to prevent serious complications and death 2 years after discharge in people with spinal cord injury in Bangladesh. Setting Bangladesh. Methods A pragmatic randomised controlled trial was undertaken. People who had sustained a spinal cord injury in the preceding 2 years, were wheelchair-dependent, and were about to be discharged from hospital in Bangladesh were recruited and randomised to an Intervention or Control group using a concealed allocation procedure stratified by level of lesion (tetraplegia/paraplegia). Participants in the Intervention group received 36 phone calls and three home visits over the first 2 years following discharge. All participants received usual post-discharge care. Survival status and date of death were determined by blinded assessors 2 years after randomisation. Results Between July 2015 and March 2018, 410 participants were randomised (204 to Intervention, 206 to Control). There was no loss to follow up. At 2 years, 15 (7.4%) participants in the Intervention group and 16 (7.8%) participants in the Control group had died (hazard ratio from unadjusted Cox model = 0.93 [95% CI, 0.46 to 1.89]; p from log rank test 0.85). There were no clinically important or statistically significant average causal effects of intervention on the incidence or severity of complications. Conclusion A program of community-based care for people with recent spinal cord injury in Bangladesh involving frequent phone contact and occasional in-person contact with a health professional after discharge from hospital is no better at preventing death at 2 years than usual care.

scholarly journals Understanding how a community-based intervention for people with spinal cord injury in Bangladesh was delivered as part of a randomised controlled trial: a process evaluation

Spinal Cord ◽  
2020 ◽  
Vol 58 (11) ◽  
pp. 1166-1175
Author(s):  
Hueiming Liu ◽  
Mohammad Sohrab Hossain ◽  
Md. Shofiqul Islam ◽  
Md. Akhlasur Rahman ◽  
Punam D. Costa ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Randomised Controlled Trial ◽  
Healthcare Professionals ◽  
Controlled Trial ◽  
Home Visits ◽  
Case Managers ◽  
Community Based ◽  
Cord Injury ◽  
Telephone Calls ◽  
Randomised Controlled

Abstract Design Mixed methods study Setting Community, Bangladesh Objectives To understand how a community-based intervention for people with spinal cord injury (SCI) in Bangladesh was delivered as part of a randomised controlled trial and to gauge the perceptions of participants and healthcare professionals to the intervention. Methods A community-based intervention was administered to 204 participants as part of a large randomised controlled trial (called the CIVIC trial). Case-managers followed-up participants with regular telephone calls and home visits over the first 2 years after discharge. The following data were collected alongside the trial: (i) chart audit of telephone calls and home visits (ii) recordings of 20 telephone calls (iii) interviews with 14 Intervention participants and four healthcare professionals including three case-managers. Results Participants received the target number of telephone calls and home visits. Pressure injuries were identified as a problem during at least one telephone call by 43% of participants. Participants and case-managers valued regular telephone calls and home visits, and believed that calls and visits prevented complications and alleviated social isolation. Participants trusted case-managers and were confident in the care and advice provided. Case-managers expressed concerns that people with SCI in Bangladesh face many problems impacting on well-being and motivation stemming from poverty, limited employment opportunities, societal attitudes and inaccessible environments. Conclusion A community-based intervention involving regular telephone calls and home visits was administered as intended and was well received by the recipients of the care. Nonetheless, people with SCI in Bangladesh face economic and social problems which cannot be fully addressed by this type of intervention alone.

scholarly journals Effects of Testosterone and Evoked Resistance Exercise after Spinal Cord Injury (TEREX-SCI): study protocol for a randomised controlled trial

BMJ Open ◽  
2017 ◽  
Vol 7 (4) ◽  
pp. e014125 ◽  
Author(s):  
Ashraf S Gorgey ◽  
Refka E Khalil ◽  
Ranjodh Gill ◽  
Laura C O'Brien ◽  
Timothy Lavis ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Randomised Controlled Trial ◽  
Resistance Exercise ◽  
Study Protocol ◽  
Controlled Trial ◽  
Cord Injury ◽  
Randomised Controlled

scholarly journals Multicentre, single-blind randomised controlled trial comparing MyndMove neuromodulation therapy with conventional therapy in traumatic spinal cord injury: a protocol study

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e039650
Author(s):  
Kim D Anderson ◽  
James R Wilson ◽  
Radha Korupolu ◽  
Jacqueline Pierce ◽  
James M Bowen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cord Injury ◽  
Upper Extremity Function ◽  
Randomised Controlled ◽  
Single Blind

IntroductionThis protocol is describing a multicentre, single-blind randomised controlled trial. The objective is to compare the efficacy of MyndMove therapy versus conventional therapy (CT) in improving upper extremity function in individuals with C4–C7 traumatic, incomplete spinal cord injury (SCI). It is being conducted in two US and two Canadian SCI rehabilitation centres.Methods and analysisSixty people aged 18 years or older with a C4–C7 incomplete (AIS B-D) SCI between 4 months and 8 years postinjury are randomised to receive 40 sessions of MyndMove neuromodulation therapy or CT within a 14-week period of time. Therapy sessions are 1 hour in duration with a dose of 3–5 sessions per week. Assessments occur prior to randomisation, after 20 sessions, after 40 sessions and 10 weeks after the last session. The primary outcome measure is the efficacy of MyndMove therapy versus CT in improving upper extremity function as measured by Spinal Cord Independence Measure III: Self-Care subscore after 40 sessions. Secondary outcomes include: (1) improvements in the SCIM mobility subscore; (2) upper limb functions measured by Graded Redefined Assessment of Strength, Sensibility and Prehension and (3) Toronto Rehab Institute Hand Function Test; (4) To assess safety as measured by serious and non-serious adverse events recorded for participants in both groups of the study population over the duration of the study; (5) to compare the change in quality of life as measured by the Spinal Cord Injury-Quality of Life; and (6) to evaluate the impact on healthcare resource utilisation.Ethics and disseminationAll ethical approvals were obtained prior to enrolling any participants. Dissemination of the results of the study will be made at peer-reviewed academic meetings and through peer-reviewed medical journalsTrial registration numberNCT03439319

scholarly journals Early exercise after spinal cord injury (‘Switch-On’): study protocol for a randomised controlled trial

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Mary P Galea ◽  
Sarah A Dunlop ◽  
Ruth Marshall ◽  
Jillian Clark ◽  
Leonid Churilov
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Controlled Trial ◽  
Early Exercise ◽  
Cord Injury ◽  
Randomised Controlled
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