Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062431) titled 'Effect of gait training using a leg brace with therapist support from behind in people with stroke who are unable to walk independently' on Aug. 1.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Ukai Rehabilitation Hospital, Keizankai Medical Corporation

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

Objective: Narrative objectives1 - The use of a knee-ankle-foot orthosis (KAFO) is recommended for patients with post-stroke hemiparesis who have insufficient knee extensor or hip muscle function. However, no standardized method of providing assistance during gait training with a KAFO has been established. Recently, Alternate Gait Training (AGT), a gait training method using a knee-ankle-foot orthosis with the oil damper ankle hinge, in which a physical therapist provides manual assistance from behind to facilitate alternating large hip flexion and extension movements during walking, has been proposed. AGT has been reported to enhance muscle activity in the paretic lower limb and produce muscle activation patterns during gait that more closely resemble those of healthy individuals. However, it remains unclear whether long-term AGT improves walking function. Therefore, the purpose of this study was to compare the long-term effects of AGT and conventional KAFO gait training on walking independence, gait pattern, and lower-limb joint kinematics in non-ambulatory patients with stroke undergoing inpatient rehabilitation. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants undergo Alternate Gait Training (AGT) using a knee-ankle-foot orthosis with the oil damper ankle hinge for at least 20 minutes per day, at least 5 days per week. Preparation and rest periods are not included in the training time. The intervention is delivered by physical therapists with at least 3 years of clinical experience who have received prior training in the principles and techniques of AGT. During AGT, the therapist maintains close contact with the participant from behind, assists trunk alignment in a neutral to forward-leaning posture throughout the gait cycle, facilitates hip extension of the paretic limb during terminal stance, and facilitates weight transfer to the non-paretic limb during the swing phase of the paretic limb. The intervention period is up to 6 weeks from the initiation of the intervention. If participants transition from a knee-ankle-foot orthosis (KAFO) to an ankle-foot orthosis (AFO) or another type of orthosis during the intervention period, the study intervention using the KAFO is discontinued at the time of transition. Interventions/Control_2 - Participants undergo gait training using a knee-ankle-foot orthosis (KAFO) for at least 20 minutes per day, 5 days per week, with as little physical assistance as possible to encourage active participation. Preparation and rest periods are not included in the training time. The intervention period is a maximum of 6 weeks from the start of the intervention. If the KAFO is replaced with an ankle-foot orthosis (AFO) or another type of orthosis during the intervention period, the study intervention using the KAFO is discontinued at the time of replacement.

Eligibility: Age-lower limit - 18 years-old = II) (5) bilateral motor paralysis Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 01 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2028 Year 07 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071323

Disclaimer: Curated by HT Syndication.