TY - JOUR
T1 - Lower-extremity dynamometry as a novel outcome measure in a double-blind, placebo-controlled, feasibility trial of intravenous immunoglobulin (IVIG) for HIV associated myelopathy
AU - Robinson-Papp, Jessica
AU - George, Mary Catherine
AU - Nmashie, Alexandra
AU - Weisz, Donald
AU - Simpson, David M.
N1 - Publisher Copyright:
© 2018, Matrix Medical Communications. All rights reserved.
PY - 2018/1/1
Y1 - 2018/1/1
N2 - Objective: Open-label data suggest that intravenous immunoglobulin (IVIG) might improve lower extremity strength in human immunodeficiency virus (HIV)-associated myelopathy (HIVM), a rare but debilitating neurologic complication of HIV. We sought to determine the feasibility of testing the efficacy of IVIG for HIVM more rigorously. Design: We conducted a randomized, double-blind, placebo-controlled feasibility trial of IVIG for HIVM, using dynamometry as an outcome measure (Clinical Trial No. NCT01561755). Setting: The study took place in an academic medical center in New York, New York Participants: Only 12 participants were enrolled in four years; critical impediments to the study were the rarity of patients with new HIVM diagnoses and prior exposure to IVIG in patients with an established diagnosis. Measurements: Dynamometry of hip flexion, knee flexion, and ankle dorsiflexion were measured; the HIV Dementia Motor Score (HDMS); and the two-minute timed walk test were utilized. Results: Recruitment was the major feasibility issue. Dynamometry was generally well-tolerated, had good test-retest reliability (r=0.71–0.86, p<0.02 for all muscle groups), and good inter-item reliability as judged by the correlations between the muscle groups (r=0.76-0.81, p=0.001–0.005). Dynamometry was valid and clinically meaningful based on its correlations with the HDMS and the two-minute timed walk test. Conclusion: We conclude that an adequately powered clinical trial of IVIG for HIVM would likely require a prolonged recruitment period and multiple participating sites. Lower limb dynamometry is a useful outcome measure for HIVM, which might also be useful in other HIV-related gait disorders.
AB - Objective: Open-label data suggest that intravenous immunoglobulin (IVIG) might improve lower extremity strength in human immunodeficiency virus (HIV)-associated myelopathy (HIVM), a rare but debilitating neurologic complication of HIV. We sought to determine the feasibility of testing the efficacy of IVIG for HIVM more rigorously. Design: We conducted a randomized, double-blind, placebo-controlled feasibility trial of IVIG for HIVM, using dynamometry as an outcome measure (Clinical Trial No. NCT01561755). Setting: The study took place in an academic medical center in New York, New York Participants: Only 12 participants were enrolled in four years; critical impediments to the study were the rarity of patients with new HIVM diagnoses and prior exposure to IVIG in patients with an established diagnosis. Measurements: Dynamometry of hip flexion, knee flexion, and ankle dorsiflexion were measured; the HIV Dementia Motor Score (HDMS); and the two-minute timed walk test were utilized. Results: Recruitment was the major feasibility issue. Dynamometry was generally well-tolerated, had good test-retest reliability (r=0.71–0.86, p<0.02 for all muscle groups), and good inter-item reliability as judged by the correlations between the muscle groups (r=0.76-0.81, p=0.001–0.005). Dynamometry was valid and clinically meaningful based on its correlations with the HDMS and the two-minute timed walk test. Conclusion: We conclude that an adequately powered clinical trial of IVIG for HIVM would likely require a prolonged recruitment period and multiple participating sites. Lower limb dynamometry is a useful outcome measure for HIVM, which might also be useful in other HIV-related gait disorders.
KW - Dynamometry
KW - Human immunodeficiency virus (HIV)
KW - Intravenous immunoglobulin (IVIG)
KW - Myelopathy
UR - http://www.scopus.com/inward/record.url?scp=85044766360&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:85044766360
SN - 2158-8333
VL - 15
SP - 28
EP - 32
JO - Innovations in Clinical Neuroscience
JF - Innovations in Clinical Neuroscience
IS - 1-2
ER -