Clinical Trial: The effect of electric ankle support using a walking aid device on knee joint movement during the standing phase after TKA surgery (Japan)

Tokyo, Aug. 4 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058683) titled 'The effect of robotic ankle electric assistance on knee joint movement during the standing phase after total knee arthroplasty' on Aug. 4.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - other

Condition: Condition - Post-TKA patients Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the effect of electric ankle support using a walking aid device on knee joint movement during the stance phase after TKA surgery Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Lower limb flexion and extension movement with walking aid ON Washout Lower limb flexion and extension movement with walking aid OFF Interventions/Control_2 - Lower limb flexion and extension movement with walking aid OFF Washout Lower limb flexion and extension movement with walking aid ON

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Those who have undergone artificial knee replacement surgery at our hospital and have been prescribed physical therapy Those with restricted knee extension while standing Those with normal ADL prior to injury and a J or A level of independence in daily living for elderly people with disabilities Those without dementia and a level of independence in daily living for elderly people with dementia of 1 or 2 Those who were able to walk independently or with a cane prior to surgery Key exclusion criteria - Those with a history of cerebrovascular disease, degenerative disease, or other diseases that affect lower limb function Those whose discharge was delayed due to postoperative complications or weight-bearing restrictions Those who did not consent to participate in the study Those for whom continuous evaluation and measurement was difficult Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 04 Day Anticipated trial start date - 2025 Year 08 Month 11 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067101

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