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

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

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Strength training for partially paralysed muscles in people with recent spinal cord injury: a within-participant randomised controlled trial

Spinal Cord ◽

10.1038/sc.2016.162 ◽

2016 ◽

Vol 55 (5) ◽

pp. 460-465 ◽

Cited By ~ 10

Author(s):

E A Bye ◽

L A Harvey ◽

A Gambhir ◽

C Kataria ◽

J V Glinsky ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Randomised Controlled Trial ◽

Strength Training ◽

Controlled Trial ◽

Cord Injury ◽

Randomised Controlled

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Influence of training protocols on text input speed on a computer in individuals with cervical spinal cord injury: a randomised controlled trial

Spinal Cord ◽

10.1038/s41393-019-0265-5 ◽

2019 ◽

Vol 57 (8) ◽

pp. 636-643

Author(s):

Samuel Pouplin ◽

Djamel Bensmail ◽

Isabelle Vaugier ◽

Axelle Gelineau ◽

Sandra Pottier ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Randomised Controlled Trial ◽

Cervical Spinal Cord ◽

Controlled Trial ◽

Cervical Spinal Cord Injury ◽

Text Input ◽

Cord Injury ◽

Randomised Controlled ◽

Training Protocols

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The effects of 10,000 voluntary contractions over 8 weeks on the strength of very weak muscles in people with spinal cord injury: a randomised controlled trial

Spinal Cord ◽

10.1038/s41393-020-0439-1 ◽

2020 ◽

Vol 58 (8) ◽

pp. 857-864 ◽

Cited By ~ 1

Author(s):

Lydia W. Chen ◽

Joanne V. Glinsky ◽

Md. Shofiqul Islam ◽

Muzaffor Hossain ◽

Claire L. Boswell-Ruys ◽

...

Keyword(s):

Spinal Cord ◽

Spinal Cord Injury ◽

Randomised Controlled Trial ◽

Controlled Trial ◽

Cord Injury ◽

Randomised Controlled ◽

Voluntary Contractions

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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 ◽

10.1038/s41393-020-00546-9 ◽

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.

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