Clinical Trial: Examination of the effect of reducing lower limb edema by combining circular needle therapy and ankle plantar flexion and dorsiflexion exercises for wheelchair-bound elderly people - A case study using a multi- layered base design method - (Japan)

Tokyo, Oct. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059586) titled 'A case study on the effects of acupuncture and ankle exercises on leg swelling in an elderly person confined to a wheelchair' on Oct. 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - Waseda University Graduate School

Condition: Condition - none Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effectiveness of combining circular needle therapy with ankle plantar flexion and dorsiflexion exercises in efficiently reducing localized pitting edema in elderly people living in nursing homes. We also examine the impact of this intervention on well-being. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - During the baseline period, each subject will perform ankle plantar flexion and dorsiflexion exercises while sitting in a wheelchair for 1 to 5 weeks. Following the baseline period, the intervention period lasts for 5 to 1 week for each subject (each subject will receive a total of 6 weeks of intervention). The subjects will perform plantar flexion and dorsiflexion exercises on the ankles while the needles are inserted and attached to acupressure points that are effective in reducing edema in the left and right lower limbs.

Eligibility: Age-lower limit - 65 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Men and women residing in the same nursing home for the elderly. 65 years of age or older. People who have difficulty walking and regularly use a wheelchair. People who spend more than half of their waking hours in a wheelchair. People who have not been diagnosed with dementia. People who can communicate clearly and willingly. People with localized pitting edema of the lower limbs of +1 or higher on the pitting test (AFTD- pitting-test). People who do not suffer from specific underlying diseases that significantly affect lower limb edema. People who have not been prescribed exercise restrictions by a doctor. People who can perform ankle plantar flexion (ankle plantar flexion range of motion 0-45 degrees) without pain while sitting in a wheelchair. People who can perform ankle dorsiflexion (ankle dorsiflexion range of motion 0-20 degrees) without pain while sitting in a wheelchair. At least 20 weeks have passed since the last acupuncture treatment at the time of intervention. People with no sensory impairments. People without metal allergies. People who do not have skin hypersensitivity caused by alcohol disinfectants. People who have never experienced contact dermatitis (bandage rash) caused by bandages. Key exclusion criteria - Those who spend more than half of their waking hours outside of a wheelchair. Those under 65 years of age. Those who can walk independently. Those who have been diagnosed with dementia. Those who are unable to communicate clearly on their own. Those who do not have localized pitting edema in the lower limbs of +1 or higher on the pitting test. Those whose exercise has been restricted by a doctor. Those who are unable to perform ankle plantar flexion (ankle plantar flexion range of motion 0-45 degrees) without pain while sitting in a wheelchair. Those who are unable to perform ankle dorsiflexion (ankle dorsiflexion range of motion 0-20 degrees) without pain while sitting in a wheelchair. Those who have not yet received acupuncture treatment within 20 weeks at the time of intervention. Those with sensory impairments. Those with metal allergies. Those with skin hypersensitivity due to alcohol disinfectants. Those who experience contact dermatitis from bandages (bandage rash). Target Size - 1

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 29 Day Anticipated trial start date - 2025 Year 10 Month 31 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068154

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