UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033151 |
|---|---|
| Receipt number | 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 | 2022/09/16 20:31:40 |
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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
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
ik7710@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
https://jrct.niph.go.jp/re/reports/detail/1356
Publication of results
Partially published
Result
URL related to results and publications
https://jrct.niph.go.jp/re/bulletins/detail/1180/4947
Number of participants that the trial has enrolled
49
Results
Data for 49 subjects (mean 80.5 years old) were compared before and after exercise by corresponding t test. As a result, the injury side ankle plantar flexor strength was 3.0kgf (p<0.05), the injured side knee extension strength was 1.3kgf (p<0.05), the injured side hip abductor strength was improved by 1.3kgf (p<0.05), BBS increased by 3.3 (p<0.01) and FRT increased by 2.3cm (p<0.05). Walking speed improved by 0.2 m/s (p<0.01) and TUG improved by -3.1 seconds (p<0.01).
Results date posted
| 2020 | Year | 02 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 07 | Month | 22 | Day |
Baseline Characteristics
The mean age of the 49 subjects was 80.5+-7.2 years, 18 males and 43 females.
Participant flow
Men and women aged 65 years or older who were hospitalized in the recovery period and who had undergone surgical procedures after sustaining a proximal femur fracture were recruited, and those who understood the study and gave consent were included.
Adverse events
none.
Outcome measures
Primary endpoint: Interviews by telephone to determine if there were any falls or fractures 1 year after the end of the intervention Secondary endpoints: - Medical record information: age, gender, current medical history, date of injury, height and weight - Motor function: gait independence (FIM; Functional Independent Measure), gait speed (10 m gait, TUG; Timed Up and Go test), balance ability (Berg Balance Scale (BBS), SIDE; Standing Gait speed (10 m walk, TUG; Timed Up and Go test) Balance ability (Berg Balance Scale (BBS), SIDE; Standing test for imbalance and disequilibrium) Muscle strength (hand-held dynamometer) (Muscle strength (lower limb muscle strength measurement using a hand-held dynamometer; hip abductor strength, knee extensor strength, ankle plantar flexor strength, grip strength)
Fall anxiety (FES-I; Falls Efficacy Scale - International)
Asking about whether pain worsens before and after practice
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
As this study falls under the category of specific clinical research, we will continue to disclose information on the progress of the study on jRCT.
https://jrct.niph.go.jp/re/reports/detail/1356
Management information
Registered date
| 2018 | Year | 06 | Month | 26 | Day |
Last modified on
| 2022 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037804
| Research Plan | |
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| Registered date | File name |
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