Spinal cord · 2021
Effect of pelvic laparoscopic implantation of neuroprosthesis in spinal cord injured subjects: a 1-year prospective randomized controlled study.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Kasch Helge, Løve Uffe Schou, Jønsson Anette Bach, Severinsen Kaare Eg, Possover Marc, Elmgreen Søren Bruno, Forman Axel
Аннотация
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.
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.