UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033151
Receipt No. R000037804
Scientific Title Verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture
Date of disclosure of the study information 2018/06/26
Last modified on 2019/06/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture
Acronym Verification of training effect with a balance exercise assist robot target femoral fracture patients
Scientific Title Verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture
Scientific Title:Acronym Verification of training effect with a balance exercise assist robot target femoral fracture patients
Region
Japan

Condition
Condition femoral fracture patients
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aim the verification of training effect with a balance exercise assist robot in rehabilitation hospital target patients with femoral fracture. The outcomes are gait, balance ability and falls experience in a year later.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes BBS; Berg balance scale
Key secondary outcomes BMI(Body Mass Index)
muscle strength (grip, length)
walking speed
SIDE(Standing test for imbalance and disequilibrium)
FRT(Functional Reach Test)
TUG(Timed Up & Go Test)

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 This study target patients with femoral fracture in rehabilitation hospital who can walk themselves under supervision. Interventions are training with a balance exercise assist robot in two weeks, twenty minutes per a day.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The general condition is stable
Strong fixation of bone fracture such as osteosynthesis
The walking FIM(functional independent measures)>=5
Informed-consent has been obtained
Key exclusion criteria Conservative treatment for fracture part
High-blood pressure(systolic blood pressure>=180 mmHg or diastolic blood pressure>=120 mmHg or resting heart rate>=120/min)
Restricted by movement due to heart function or respiratory function disorder
hearing or visual impairment
Dementia or severe higher brain dysfunction
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code 474-8511
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Email ik7710@ncgg.go.jp

Public contact
Name of contact person
1st name Izumi
Middle name
Last name Kondo
Organization National Center for Geriatrics and Gerontology
Division name Rehabilitation Center
Zip code 474-8511
Address 7-430, Moriokacho, Obu-shi, Aichi, 474-8511, Japan
TEL 0562-46-2311
Homepage URL
Email ik7710@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization TOYOTA MOTOR CORPORATION
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya University
Address 65, Tsurumai, Showaku, Nagoya
Tel 052-744-2061
Email nishida.kazuhiro@adm.nagoya-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 国立研究開発法人 国立長寿医療研究センター(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 06 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Data for 25 subjects (mean 81 +- 6 years old) were compared before and after exercise by corresponding t test. As a result, the injury side ankle plantar flexor strength was 4.2kgf (p<0.05), the injured side knee extension strength was 1.9kgf (p<0.05), the injured side hip abductor strength was improved by 1.3kgf (p<0.05), BBS increased by 3.4 (p<0.01) and FRT increased by 2.3cm (p<0.05). Walking speed improved by 0.18 m/s (p<0.01) and TUG improved by -4.9 seconds (p<0.01)
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 Enrolling by invitation
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
2019 Year 05 Month 31 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2021 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
2018 Year 06 Month 26 Day
Last modified on
2019 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037804

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.