UMIN-CTR Clinical Trial

Public title

A case study on the effects of acupuncture and ankle exercises on leg swelling in an elderly person confined to a wheelchair

Acronym

A case study on the effects of acupuncture and ankle exercises on leg swelling in an elderly wheelchair user

Scientific Title

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 -

Scientific Title:Acronym

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

Region

Japan

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The maximum circumference of the lower leg was measured for 6 weeks.

Key secondary outcomes

Visual Analogue Scale measurements of swelling were taken for 6 weeks.
The WHO-5 Mental Health Status Inventory (Short Version) (S-WHO-5-J) was measured for 7 weeks.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

YES

Concealment

No need to know

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment	Behavior,custom	Maneuver

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.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

1

Name of lead principal investigator

1st name	Koichiro
Middle name
Last name	Oka

Organization

Waseda University

Division name

Faculty of Sport Sciences

Zip code

359-1192

Address

579-15 Mikashima 2-chome, Tokorozawa City, Saitama Prefecture

TEL

04-2947-7189

Email

koka@waseda.jp

Name of contact person

1st name	Takuya
Middle name
Last name	Komabayashi

Organization

Waseda University Graduate School

Division name

Graduate School of Sports Science

Zip code

359-1192

Address

579-15 Mikashima 2-chome, Tokorozawa City, Saitama Prefecture

TEL

090-6653-1978

Homepage URL

Email

komabayashi7@toki.waseda.jp

Institute

Waseda University Graduate School

Institute

Department

Personal name

Organization

self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Waseda University Research Ethics Office

Address

1-6-1 Nishi-Waseda, Shinjuku-ku

Tel

03-5272-1639

Email

rinri@list.waseda.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

特別養護老人ホーム万葉の郷（埼玉県）/Manyo no Sato Special Nursing Home for the Elderly (Saitama Prefecture)

Date of disclosure of the study information

2025

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

10

Month

29

Day

Date of IRB

Anticipated trial start date

2025

Year

10

Month

31

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

10

Month

29

Day

Last modified on

2025

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068154