Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060154) titled 'A study on the effects of functional electrical stimulation (FES) on gait rehabilitation after lumbar spine surgery' on Jan. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Gakkentoshi Hospital
Condition:
Condition - Patients following lumbar spine surgery
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the effects of gait training combined with functional electrical stimulation after surgery for degenerative lumbar spine disease
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The baseline phase (A) will last for two weeks, followed by a two-week intervention phase (B).
During the intervention phase, functional electrical stimulation will be applied in combined with gait training.
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients scheduled to undergo surgery for degenerative lumbar spine disease
Able to ambulate
Ankle dorsiflexor muscle strength less than MMT grade 3
Key exclusion criteria - Individuals with contraindications to electrical stimulation therapy, such as those with implanted pacemakers
Individuals with other neurological or neuromuscular disorders, such as stroke
Individuals with other musculoskeletal disorders
Individuals with a history of prior spine surgery
Target Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 09 Month 12 Day
Date of IRB - 2025 Year 09 Month 12 Day
Anticipated trial start date - 2026 Year 01 Month 01 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068752
Disclaimer: Curated by HT Syndication.
