UMIN-CTR Clinical Trial

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
Email	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
Email	tmorishita@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034051