Tokyo, Oct. 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063330) titled 'Effects of Eyes-Closed Standing Training on a Foam Surface on Postural Control in Patients With Stroke: A Multicenter Randomized Controlled Trial' on Oct. 25.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Fukuoka Rehabilitation Hospital
Condition:
Condition - Stroke
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To investigate the short-term effects of one week of eyes-closed standing training on a foam surface on static standing postural control and balance performance in patients with stroke, compared with usual rehabilitation.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The Mat group will receive standing training using a standardized balance mat (manufactured by Hapquitous Inc., EquiTest-compliant, and designed for frailty and vestibular function assessment) as part of a 60-minute usual rehabilitation session. The standing task will be performed primarily with eyes closed, with the feet positioned 10 cm apart and the arms crossed over the chest. Training will consist of up to six 30-second sets per session, five times per week for one week. After each intervention session, subjective task difficulty will be assessed using a Visual Analog Scale (VAS).
The intervention will be discontinued if the Borg Scale score reaches 15 or higher, if the participant is unable to maintain standing safely, if the participant requests discontinuation, or if the treating physical therapist determines that continuation is unsafe.
Interventions/Control_2 - The Control group will receive 60 minutes of usual rehabilitation. No additional standing training on an unstable support surface will be provided as part of the study. Usual rehabilitation may include range-of-motion exercises, muscle strengthening exercises, standing and balance training, gait training, and activities of daily living (ADL) training. The content of usual rehabilitation in both groups will be recorded using a standardized checklist.
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1. Patients with first-ever stroke.
2. Hospitalized patients undergoing rehabilitation.
3. Patients who are able to perform standing tasks under appropriate safety supervision.
4. Patients who are able to understand the instructions for the study tasks.
5. Patients who provide written informed consent after receiving an explanation of the study.
Key exclusion criteria - 1. Patients with orthopedic disorders that substantially affect standing and balance performance.
2. Patients with neurological disorders other than stroke.
3. Patients with comorbidities, such as severe heart failure, that may compromise the safe performance of standing tasks.
4. Patients who have difficulty understanding or performing the study tasks due to severe cognitive impairment or other conditions.
5. Patients who are judged by the treating physician or physical therapist to be unable to participate in the study for other reasons.
Target Size - 128
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 10 Month 13 Day
Anticipated trial start date - 2026 Year 12 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072429
Disclaimer: Curated by HT Syndication.
