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
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
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
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
