Tokyo, Jan. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060276) titled 'Immediate Effect of Proprioceptive Training and Tactile Stimulation for Improving Balance during Closed-Eyes Condition: Randomized Controlled Trial' on Jan. 6.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -participants are blinded
Control - Active
Primary Sponsor:
Institute - Tokyo Metropolitan University
Condition:
Condition - Healthy adults without known neurological, musculoskeletal, or balance disorders
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to examine the immediate effects of proprioceptive training and tactile stimulation on balance performance under eyes-closed conditions in healthy adults, and to explore concurrent changes in cortical activation measured by fNIRS during the balance tasks.
Basic objectives2 - Others
Intervention:
Interventions/Control_1 - Group 1 (Unstable surface with plantar tactile stimulation):
Participants performed eyes-closed standing balance tasks on an unstable surface while receiving tactile stimulation through a textured plantar surface placed under the feet. Participants were allowed to hold a handrail for safety purposes. The protocol consisted of a single-session (immediate). Balance tasks were performed while cortical activation was recorded using fNIRS. Balance outcomes (OLST and MDRT) were assessed immediately after the session.
Interventions/Control_2 - Group 2 (Unstable surface without plantar tactile stimulation):
Participants performed eyes-closed standing balance tasks on an unstable surface without additional plantar tactile stimulation (non-textured surface). Participants were allowed to hold a handrail for safety purposes. The protocol consisted of a single session (immediate). Balance tasks were performed while cortical activation was recorded using fNIRS. Balance outcomes (OLST and MDRT) were assessed immediately after the session.
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Inclusion criteria were: age between 18 and 50 years; normal or corrected-to-normal vision; intact sensorimotor and proprioceptive function; and ability to provide voluntary informed consent.
Key exclusion criteria - Exclusion criteria included a history of neurological, vestibular, or acute musculoskeletal disorders that could affect balance performance, as well as any communication impairments preventing task understanding.
Target Size - 40
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2024 Year 08 Month 01 Day
Date of IRB - 2024 Year 10 Month 02 Day
Anticipated trial start date - 2024 Year 10 Month 10 Day
Last follow-up date - 2025 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068951
Disclaimer: Curated by HT Syndication.