UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029803 |
|---|---|
| Receipt number | R000034051 |
| Scientific Title | Pilot study to establish the treatment of patients with frailty and sarcopenia using the device of promoting neural control of paravertebral muscle |
| Date of disclosure of the study information | 2017/11/02 |
| Last modified on | 2021/02/19 13:14:59 |
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Basic information
Public title
Pilot study to establish the treatment of patients with frailty and sarcopenia using the device of promoting neural control of paravertebral muscle
Acronym
Pilot study to establish the treatment of patients with frailty and sarcopenia using the device of promoting neural control of paravertebral muscle
Scientific Title
Pilot study to establish the treatment of patients with frailty and sarcopenia using the device of promoting neural control of paravertebral muscle
Scientific Title:Acronym
Pilot study to establish the treatment of patients with frailty and sarcopenia using the device of promoting neural control of paravertebral muscle
Region
| Japan |
Condition
Condition
Lower back pain patients with frailty/sarcopenia, or having muscle weakness in their previous stage
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the training effect of HAL-CB02-assisted training in patients with lumbago and frailty/sarcopenia, or having muscle weakness in their previous stage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain evaluation by VAS, RDQ and SF-MPQ-2,10m walk, Timed Up and Go Test
Key secondary outcomes
Analysis for factors to relate the efficacy of HAL-CB02-assisted training: Gender, age, height, weight, grip strength, lower limb circumference, posture measurement, complicated spinal or spine disease analyzed by CT and muscle cross-sectional area (paravertebral muscle, quadriceps femoris muscle) estimated by CT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Body trunk and squat training as many times as possible with HAL-CB02 for 30 minutes per day. The above training is performed for 5 days during weekdays. We assesse and compare at pre and post HAL-CB02 training and 3 months later
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients signed an informed consent document
2.Patients with lumbago
3.Patients diagnosed with frailty or sarcopenia
Key exclusion criteria
1. Patients with severe cognitive impairment or mental illness
2. Patients disable to wear the device because of the body size or so
3. Patients enrolled to the other clinical study
4. Patients ineligible to the study based on investigator`s decision
5. Patients who take no proper treatment of lumber spinal canal stenosis, hernia or other diseases which could be a cause for lumbago
6. Patients with vertebral fractures or lower limb fractures developed in 6 months
7. Patients with coxarthrosis
8. Patients with poor general condition such as heart failure
9. Bedridden patients
10. Patients who need treatment of the other disease prior to frailty or sarcopenia caused by lumbago
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tooru |
| Middle name | |
| Last name | Inoue |
Organization
Fukuoka University Hospital
Division name
Department of Neurosurgery
Zip code
814-0180
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
toinoue@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Morishita |
Organization
Fukuoka University Hospital
Division name
Department of Neurosurgery
Zip code
814-0180
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, 814-0180, Japan
TEL
092-801-1011
Homepage URL
tmorishita@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University
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
Fukuoka University institutional review board
Address
7-45-1, Nanakuma, Johnan-ku, Fukuoka, Japan
Tel
092-801-1011
fumed-ethics@fukuoka-u.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
福岡大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
Main results already published
Date of protocol fixation
| 2017 | Year | 09 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 02 | Day |
Last modified on
| 2021 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034051
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
