Tokyo, May 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061593) titled 'Immediate impact of interferential current electrical stimulation in patients with dysphagia' on May 18.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Open -no one is blinded
Control - Placebo
Primary Sponsor:
Institute - Akashi Rehabilitation Hospital
Condition:
Condition - Dysphagia
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The present study aimed to investigate both immediate and sustained effects of interferential current electrical stimulation (IFCS) from multiple perspectives by assessing small- and large-volume water intakes, saliva swallowing, and cough test (reflecting laryngeal sensation).
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Interferential current stimulation: Stimulation intensity was 3.0mA
Interventions/Control_2 - Interferential current stimulation: Stimulation intensity was 0.1mA
Eligibility:
Age-lower limit - 20
years-old
= 3 and a Functional Oral Intake Scale (FOIS) =< 6
Key exclusion criteria - 1.dry mouth syndrome
2.head and neck cancer
3.severe cognitive impairment to the extent of being unable to comprehend instructions
4.asthma
5.epilepsy
6.use of a pacemaker
Target Size - 33
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 07 Month 06 Day
Date of IRB - 2023 Year 07 Month 06 Day
Anticipated trial start date - 2023 Year 08 Month 01 Day
Last follow-up date - 2026 Year 05 Month 16 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070473
Disclaimer: Curated by HT Syndication.
