Tokyo, March 5 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060820) titled 'A pilot study of gait training using KAFO in stroke patients: Comparison between patient-paced and therapist-led approaches' on March 4.

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 - Naka-Izu Rehabilitation Center

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

Objective: Narrative objectives1 - The purpose of this pilot study is to clarify whether patient-paced alternate gait training (PP-AGT) or therapist-led alternate gait training (TL-AGT) is more effective in improving gait ability in stroke patients using knee-ankle-foot orthoses (KAFO). The results will be used to obtain information necessary for calculating the accurate sample size for a subsequent main study. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention 1: Patient-Paced Alternate Gait Training (PP-AGT) Description: Walking training is performed using a knee-ankle-foot orthosis (KAFO) with a Gait Solution ankle joint and the knee joint locked in extension. The training involves an alternate gait pattern, stepping forward with each leg alternately. Specific Conditions: The use of parallel bars or a cane is allowed. The walking pace is determined by the participant (patient-paced), and the physical therapist (PT) provides only the minimal assistance necessary to maintain the gait movement. Protocol: At least 5 sessions per week, with a total duration of 10 minutes or more per session. Interventions/Control_2 - Intervention 2: Therapist-Led Alternate Gait Training (TL-AGT) Description: Walking training is performed using a knee-ankle-foot orthosis (KAFO) with a Gait Solution ankle joint and the knee joint locked in extension. The training involves an alternate gait pattern, stepping forward with each leg alternately. Specific Conditions: The use of assistive devices such as parallel bars or canes is prohibited. The physical therapist (PT) supports the participant from behind and actively guides and leads the rhythmic walking movements. Protocol: At least 5 sessions per week, with a total duration of 10 minutes or more per

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Stroke patients with hemiplegia Patients requiring total assistance for walking at admission (Functional Independence Measure [FIM] gait score of 1) Patients meeting the following criteria for requiring a knee-ankle-foot orthosis (KAFO): Inability to walk appropriately with an ankle-foot orthosis (AFO) due to physical issues such as knee buckling or hyperextension (genu recurvatum) Absence of joint range of motion (ROM) limitations in the lower limbs that would hinder alternate gait training (AGT) Presence of moderate to severe motor paralysis, defined as a Stroke Impairment Assessment Set (SIAS) knee motor score of 3 or less Patients whose participation is approved by the physical therapist in charge Key exclusion criteria - Patients who are discharged within 3 months after the start of AGT Patients with more than 3 months elapsed from stroke onset to the start of AGT Target Size - 10

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 01 Day Date of IRB - 2026 Year 03 Month 01 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069596

Disclaimer: Curated by HT Syndication.