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 |
Effect of wearable and feedback devices on static standing and level walking of amputees
Effect of wearable and feedback devices on static standing and level walking of amputees
Effect of wearable and feedback devices on static standing and level walking of amputees
Effect of wearable and feedback devices on static standing and level walking of amputees
Japan |
Lower limb amputation
Rehabilitation medicine |
Others
NO
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.
Efficacy
Confirmatory
Pragmatic
Not applicable
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.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
YES
NO
Institution is not considered as adjustment factor.
NO
No need to know
4
Treatment
Other |
Three trials of level walking
Three trials of level walking with a wearable device
Three trials of level walking with a feedback device
Three trials of level walking with both wearable and feedback devices
20 | years-old | <= |
70 | years-old | > |
Male and Female
Able to walk with prosthetic legs for 10m without walking aids
transfemoral amputee
Amputation is due to peripheral neuropathy such as diabetes mellitus
10
1st name | Junji |
Middle name | |
Last name | Katsuhira |
Toyo University
Faculty of Life Design
115-8650
Akabanedai1-7-11, Kitaku, Tokyo
03-5924-2267
katsuhira@toyo.jp
1st name | Junji |
Middle name | |
Last name | Katsuhira |
Toyo University
Faculty of Life Design
1158650
Akabanedai1-7-11, Kitaku, Tokyo
0359242267
katsuhira@toyo.jp
Toyo University
Grant-in-Aid for Scientific Research (C)
Japanese Governmental office
Japan
Toyo University
Akabanedai1-7-11, Kitaku, Tokyo
03-5924-2148
ml-akj@toyo.jp
NO
2022 | Year | 07 | Month | 18 | Day |
DOI:10.1097/PXR.0000000000000458
Published
https://pubmed.ncbi.nlm.nih.gov/40498880/
10
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.
2025 | Year | 06 | Month | 20 | Day |
2025 | Year | 06 | Month | 11 | Day |
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.
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).
No adverse events were observed in any of the participants during the study period.
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
Completed
2022 | Year | 06 | Month | 29 | Day |
2022 | Year | 06 | Month | 29 | Day |
2022 | Year | 07 | Month | 21 | Day |
2023 | Year | 03 | Month | 31 | Day |
2022 | Year | 07 | Month | 15 | Day |
2025 | Year | 06 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055157