scholarly journals Electrophysiological Outcome Measures in Spinal Cord Injury Clinical Trials: A Systematic Review

2019 ◽  
Vol 25 (4) ◽  
pp. 340-354
Author(s):  
Radha Korupolu ◽  
Argyrios Stampas ◽  
Mani Singh ◽  
Ping Zhou ◽  
Gerard Francisco
Keyword(s):  
Systematic Review ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Evoked Potentials ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Silent Period ◽  
Contact Heat Evoked Potentials ◽  
Cord Injury

Background: Electrophysiological measures are being increasingly utilized due to their ability to provide objective measurements with minimal bias and to detect subtle changes with quantitative data on neural function. Heterogeneous reporting of trial outcomes limits effective interstudy comparison and optimization of treatment. Objective: The objective of this systematic review is to describe the reporting of electrophysiological outcome measures in spinal cord injury (SCI) clinical trials in order to inform a subsequent consensus study. Methods: A systematic search of PubMed and EMBASE databases was conducted according to PRISMA guidelines. Adult human SCI clinical trials published in English between January 1, 2008 and September 15, 2018 with at least one electrophysiological outcome measure were eligible. Findings were reviewed by all authors to create a synthesis narrative describing each outcome measure. Results: Sixty-four SCI clinical trials were included in this review. Identified electrophysiological outcomes included electromyography activity (44%), motor evoked potentials (33%), somatosensory evoked potentials (33%), H-reflex (20%), reflex electromyography activity (11%), nerve conduction studies (9%), silent period (3%), contact heat evoked potentials (2%), and sympathetic skin response (2%). Heterogeneity was present in regard to both methods of measurement and reporting of electrophysiological outcome measures. Conclusion: This review demonstrates need for the development of a standardized reporting set for electrophysiological outcome measures. Limitations of this review include exclusion of non-English publications, studies more than 10 years old, and an inability to assess methodological quality of primary studies due to a lack of guidelines on reporting of systematic reviews of outcome measures.

scholarly journals Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study

Spinal Cord ◽  
2021 ◽  
Author(s):  
Helge Kasch ◽  
Uffe Schou Løve ◽  
Anette Bach Jønsson ◽  
Kaare Eg Severinsen ◽  
Marc Possover ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Control Group ◽  
Walking Ability ◽  
Data Set ◽  
Cord Injury

Abstract Study design 1-year prospective RCT. Objective Examine the effect of implantable pulse generator and low-frequency stimulation of the pelvic nerves using laparoscopic implantation of neuroprosthesis (LION) compared with neuromuscular electrical stimulation (NMES) in SCI. Methods Inclusion criteria: traumatic spinal cord injury (SCI), age 18–55 years, neurological level-of-injury Th4–L1, time-since-injury >1 year, and AIS-grades A–B. Participants were randomized to (A) LION procedure or (B) control group receiving NMES. Primary outcome measure: Walking Index for Spinal Cord Injury (WISCI-II), which is a SCI specific outcome measure assessing ability to ambulate. Secondary outcome measures: Spinal Cord Independence Measure III (SCIM III), Patient Global Impression of Change (PGIC), Penn Spasm Frequency Scale (PSFS), severity of spasticity measured by Numeric Rating Scale (NRS-11); International Spinal Cord Injury data sets-Quality of Life Basic Data Set (QoLBDS), and Brief Pain Inventory (BPI). Results Seventeen SCI individuals, AIS grade A, neurological level ranging from Th4–L1, were randomized to the study. One individual was excluded prior to intervention. Eight participants (7 males) with a mean age (SD) of 35.5 (12.4) years were allocated to the LION procedure, 8 participants (7 males) with age of 38.8 (15.1) years were allocated to NMES. Significantly, 5 LION group participants gained 1 point on the WISCI II scale, (p < 0.013; Fisher´s exact test). WISCI II scale score did not change in controls. No significant changes were observed in the secondary outcome measures. Conclusion The LION procedure is a promising new treatment for individuals with SCI with significant one-year improvement in walking ability.

scholarly journals Walking Ability Outcome Measures in Individuals with Spinal Cord Injury: A Systematic Review

2021 ◽  
Vol 18 (18) ◽  
pp. 9517
Author(s):  
Isabel Sinovas-Alonso ◽  
Ángel Gil-Agudo ◽  
Roberto Cano-de-la-Cuerda ◽  
Antonio J. del-Ama
Keyword(s):  
Systematic Review ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Outcome Measures ◽  
Berg Balance Scale ◽  
Walking Ability ◽  
Walk Test ◽  
Timed Up And Go ◽  
Cord Injury ◽  
Profile Score

Walking function recovery in spinal cord injury (SCI) is tackled through several therapeutic approaches in which precise evaluation is essential. A systematic review was performed to provide an updated qualitative review of walking ability outcome measures in SCI and to analyze their psychometric properties. PubMed, Cochrane, and PEDro databases were consulted until 1 April 2020. Seventeen articles written in English were included. Five of them studied the walking index for SCI, four studied the 10 meter walk test, and two studied the six-minute walk test, the timed Up and go test, and the Berg balance scale. The rest of the articles studied the following metrics: gait profile score, spinal cord injury functional ambulation profile, five times sit-to-stand test, spinal cord injury functional ambulation inventory, spinal cord independence measure (indoors and outdoors mobility items), locomotor stages in spinal cord injury, community balance and mobility scale, and activity-based balance level evaluation scale. The choice of a single or a set of metrics should be determined by the clinician. Based on the results obtained in this review, a combination of outcome measures is proposed to assess walking ability. Future work is required to integrate a more realistic environment for walking assessment.

scholarly journals Spinal cord injury and quality of life: a systematic review of outcome measures

2011 ◽  
Vol 2 (01) ◽  
pp. 37-44 ◽  
Author(s):  
Jefferson Wilson ◽  
Robin Hashimoto ◽  
Joseph Dettori ◽  
Michael Fehlings
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Outcome Measures ◽  
Cord Injury

scholarly journals Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures

Spinal Cord ◽  
2006 ◽  
Vol 45 (3) ◽  
pp. 206-221 ◽  
Author(s):  
J D Steeves ◽  
D Lammertse ◽  
A Curt ◽  
J W Fawcett ◽  
M H Tuszynski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Trial Outcome ◽  
Clinical Trial Outcome ◽  
Cord Injury

The development of an outcome measures toolkit for spinal cord injury rehabilitation

2017 ◽  
Vol 84 (2) ◽  
pp. 119-129 ◽  
Author(s):  
Christie W. L. Chan ◽  
William C. Miller ◽  
Matthew Querée ◽  
Vanessa K. Noonan ◽  
Dalton L. Wolfe ◽  
...  
Keyword(s):  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Practice ◽  
Outcome Measures ◽  
Best Practice ◽  
Outcome Measure ◽  
Medical Condition ◽  
Measurement Properties ◽  
Injury Rehabilitation ◽  
Cord Injury

Background. Spinal cord injury (SCI) is a complex medical condition that can be difficult to monitor. Purpose. This study aimed to establish a common set of validated outcome measures specifically for SCI clinical practice. Method. In a three-round online Delphi process, experts in SCI care across Canada suggested and ranked outcome measures for clinical practice. The facilitators provided feedback between rounds and determined if consensus (at least 75% agreement) was reached on a single outcome measure per clinical area. Findings. One hundred and forty-eight outcome measures were initially considered for inclusion. After three rounds, consensus was reached for 23 out of 30 clinical areas. In the remaining seven, more than one outcome measure was recommended. The final toolkit comprises 33 outcome measures with sufficient measurement properties for use with a SCI population. Implications. An outcome measures toolkit validated specifically for SCI should lead to improved identification of best practice and enable clinicians to monitor client progress effectively.

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