Clinical Trial: Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients (Japan)

Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062432) titled 'Verification of the Efficacy of Orthobot-Assisted Gait Training in the Transition from KAFO to AFO for Stroke Hemiplegia Patients' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - n-of-1 Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Condition: Condition - Stroke Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - During gait training for stroke patients with hemiplegia, the quality of assistance provided during knee joint lock-off in the transition phase from a knee-ankle-foot orthosis to an ankle-foot orthosis tends to vary depending on the therapist's years of experience. The gait-learning support robot Orthobot, developed by Suncall Corporation, enables safe gait training by automatically controlling knee flexion and extension. However, no cases have been identified to date combining the Orthobot with a plastic AFO-type KAFO. The objective is therefore to verify whether attaching the Orthobot to a plastic AFO-type KAFO and utilizing it for gait learning during knee joint lock-off can resolve the aforementioned issue. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Conventional physical therapy. The participant performs 40 minutes of gait training per day for 5 days using a custom-made knee-ankle-foot orthosis with a spring-assisted extension (SPEX) knee joint in the unlocked condition, without the robotic device.This study employs an A-B-A design, in which Intervention 1, Intervention 2, and Intervention 1 are administered in this order for 5 days each. Interventions/Control_2 - The Orthobot is mounted onto the same SPEX-KAFO using a universal attachment and used in the "stumble prevention assist" mode for 40 minutes of gait training per day for 5 days. The Orthobot is not an approved medical device under the Japanese Pharmaceuticals and Medical Devices Act; it is certified under ISO 13482 as a personal care robot. This study employs an A-B-A design, in which Intervention 1, Intervention 2, and Intervention 1 are administered in this order for 5 days each.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients with hemiplegia following stroke admitted to our hospital's convalescent rehabilitation ward. Patients prescribed rehabilitation for cerebrovascular disease or similar conditions. Patients for whom a customized knee-ankle-foot orthosis (KAFO) with a spring-assisted extension (SPEX) knee joint was fabricated to improve walking ability. Patients whose orthosis allowed the Orthobot to be mounted using the universal attachment. Patients for whom the necessity of the KAFO was discussed by a team including a rehabilitation specialist during an orthotic consultation. Patients for whom lower limb muscle activity (electromyography) data could be obtained. Patients who provided informed consent to participate in this study. Key exclusion criteria - Individuals for whom the purpose of KAFO fabrication was not to acquire walking ability, but rather to improve durability. Individuals prescribed bilateral KAFOs. Individuals with significant orthopedic conditions (as these may affect walking ability). Individuals whose stroke was not a first-ever event.

(The following are criteria for exclusion from analysis or withdrawal) Individuals with missing values in the data required for analysis (muscle activity data or FIM scores). Individuals who withdrew during the study period owing to poor physical condition or other reasons. Target Size - 2

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2025 Year 09 Month 30 Day Date of IRB - 2025 Year 10 Month 21 Day Anticipated trial start date - 2025 Year 10 Month 06 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068974

Disclaimer: Curated by HT Syndication.