UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045126 |
|---|---|
| Receipt number | R000051542 |
| Scientific Title | Effect of Exercises Training Using Hybrid Assistive Limb (HAL) Lumbar Type on Squatting Motion -Biomechanical analysis with synchronized electromyography |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/08/15 12:23:12 |
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Basic information
Public title
Effect of Exercises Training Using Hybrid Assistive Limb (HAL) Lumbar Type on Squatting Motion
-Biomechanical analysis with synchronized electromyography
Acronym
Effect of Exercises Training Using Hybrid Assistive Limb (HAL) Lumbar Type on Squatting Motion
-Biomechanical analysis with synchronized electromyography
Scientific Title
Effect of Exercises Training Using Hybrid Assistive Limb (HAL) Lumbar Type on Squatting Motion
-Biomechanical analysis with synchronized electromyography
Scientific Title:Acronym
Effect of Exercises Training Using Hybrid Assistive Limb (HAL) Lumbar Type on Squatting Motion
-Biomechanical analysis with synchronized electromyography
Region
| Japan |
Condition
Condition
musculoskeletal system
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare trunk and lower limb joint angle and electromyogram changes of trunk and lower limb muscles in squatting between exercises with and without HAL lumbar type.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trunk and lower limb joint angles and
electromyogram of erector spinae muscle and hip/knee joint
Key secondary outcomes
1.Flexibility before and after the exercise (Finger floor distance, Straight leg raising)
2. evaluation of subjective fatigue level VAS before and after exercise
3. HAL monitor analysis during exercise with HAL (biopotential signal, assist torque, trunk angle)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Exercise training with HAL lumbar type
1. Repeat pelvic tilt forward and backward in sitting position for 1 minute and 30 seconds
2. Repeatedly stand up from sitting position for 1 minute and 30 seconds
3. Repeat 3 sets of 10 squats
Interventions/Control_2
Exercise training without HAL lumbar type
1. Repeat pelvic tilt forward and backward in sitting position for 1 minute and 30 seconds
2. Repeatedly stand up from sitting position for 1 minute and 30 seconds
3. Repeat 3 sets of 10 squats
Interventions/Control_3
Interventions/Control_4
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. A healthy subject who is able to give written consent.
2.A healthy subject who can wear HAL lumber type.
Key exclusion criteria
1. A healthy subject who can not apply HAL bioelectrocodes due to skin disorders.
2. An individuals who are judged inappropriate for participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Yamazaki |
Organization
University of Tsukuba
Division name
Department of Orthopaedic Surgery, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298533219
masashiy@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Kikuchi |
Organization
University of Tsukuba
Division name
Department of Orthopaedic Surgery, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL
0298533219
Homepage URL
nhskikuchi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research & Development Organization
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
0298533914
t-credo.adm@un.tsukuba.ac.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
筑波大学附属病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051542
