UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048390
Receipt number R000055157
Scientific Title Effect of wearable and feedback devices on static standing and level walking of amputees
Date of disclosure of the study information 2022/07/18
Last modified on 2025/06/20 12:15:18

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Basic information

Public title

Effect of wearable and feedback devices on static standing and level walking of amputees

Acronym

Effect of wearable and feedback devices on static standing and level walking of amputees

Scientific Title

Effect of wearable and feedback devices on static standing and level walking of amputees

Scientific Title:Acronym

Effect of wearable and feedback devices on static standing and level walking of amputees

Region

Japan


Condition

Condition

Lower limb amputation

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop and experimentally evaluate the effectiveness of a wearable device capable of modifying and providing feedback on pelvic and trunk alignment in lower limb amputees.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Immediate changes in ground reaction force, center of pressure, joint angle, joint moment, power, and spatiotemporal gait parameters while using the wearable and feed back devices.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Three trials of level walking

Interventions/Control_2

Three trials of level walking with a wearable device

Interventions/Control_3

Three trials of level walking with a feedback device

Interventions/Control_4

Three trials of level walking with both wearable and feedback devices

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male and Female

Key inclusion criteria

Able to walk with prosthetic legs for 10m without walking aids
transfemoral amputee

Key exclusion criteria

Amputation is due to peripheral neuropathy such as diabetes mellitus

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Junji
Middle name
Last name Katsuhira

Organization

Toyo University

Division name

Faculty of Life Design

Zip code

115-8650

Address

Akabanedai1-7-11, Kitaku, Tokyo

TEL

03-5924-2267

Email

katsuhira@toyo.jp


Public contact

Name of contact person

1st name Junji
Middle name
Last name Katsuhira

Organization

Toyo University

Division name

Faculty of Life Design

Zip code

1158650

Address

Akabanedai1-7-11, Kitaku, Tokyo

TEL

0359242267

Homepage URL


Email

katsuhira@toyo.jp


Sponsor or person

Institute

Toyo University

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (C)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Toyo University

Address

Akabanedai1-7-11, Kitaku, Tokyo

Tel

03-5924-2148

Email

ml-akj@toyo.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 07 Month 18 Day


Related information

URL releasing protocol

DOI:10.1097/PXR.0000000000000458

Publication of results

Published


Result

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/40498880/

Number of participants that the trial has enrolled

10

Results

In this study, the effectiveness of a new feedback system using orthotics and inertial sensors was tested in 10 thigh amputees by walking tests under four conditions.Although there were no significant differences in similarity indices, there were significant changes in the range of motion of the trunk and pelvis, including rotation and lateral flexion.

Results date posted

2025 Year 06 Month 20 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2025 Year 06 Month 11 Day

Baseline Characteristics

Ten male participants with unilateral transfemoral amputation (mean age 34.2 years,SD10.32) were enrolled in this study. All were classified as K level 3 and could walk continuously for more than 10 meters. The average time since amputation was 11.9 years, and their adaptation status was individually assessed. Participants did not include those with vascular amputations caused by end-stage neuropathy such as diabetes or those with residual limb or spinal pain. None of the participants had knee osteoarthritis or back pain requiring orthopedic treatment at the time of participation, and informed consent was obtained before the start of the study.

Participant flow

Femoral amputees were recruited for the study (10 men were determined eligible and agreed to participate).

Based on eligibility criteria, subjects were selected who were at least 6 months post-amputation and capable of walking continuously for at least 10 meters.

No subject was found to meet the exclusion criteria.

All 10 successful applicants participated in the study and data were obtained for all walking conditions (4 conditions).

Data from all 10 subjects were included in the analysis (no dropouts).

Adverse events

No adverse events were observed in any of the participants during the study period.

Outcome measures

Primary Outcome:

Symmetry Index (SI) of trunk and pelvis

Change in trunk and pelvis joint range of motion (ROM) during walking
(Comparison between conditions, focusing on lateral flexion and rotation in the forehead and horizontal planes)

Secondary Outcomes:

Spatiotemporal parameters of gait (gait speed, stride length, step length, stance time, etc.)

Sensor feedback and postural changes with and without orthosis

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2022 Year 06 Month 29 Day

Date of IRB

2022 Year 06 Month 29 Day

Anticipated trial start date

2022 Year 07 Month 21 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 07 Month 15 Day

Last modified on

2025 Year 06 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055157