UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045848 |
|---|---|
| Receipt number | R000052324 |
| Scientific Title | Exploring rehabilitation therapy with the Partner Robot |
| Date of disclosure of the study information | 2021/10/25 |
| Last modified on | 2022/07/22 09:27:06 |
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Basic information
Public title
Exploring rehabilitation therapy with the Partner Robot
Acronym
Exploring rehabilitation therapy with the Partner Robot
Scientific Title
Exploring rehabilitation therapy with the Partner Robot
Scientific Title:Acronym
Exploring rehabilitation therapy with the Partner Robot
Region
| Japan |
Condition
Condition
Patients with balance disorders
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the therapeutic effect of rehabilitation treatment using gait exercise assist robot and balance exercise assist robot, hereafter referred to as Partner Robot, for people who have developed gait and balance disorders due to various diseases.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Balance Evaluation Systems Test ( BESTest )
Key secondary outcomes
mini-BESTest, Berg Balance Scale, length of center of pressure, muscle strength, grip power
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
Gait training with gait exercise assist robot.
Balance training with balance exercise assist robot.
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
| 81 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with gait or balance disorders.
Key exclusion criteria
Those who may not be able to follow the instructions of the therapist.
Those with severe aphasia (FIM comprehension score of 2 or less)
Those with severe higher brain dysfunction (FIM Social Interaction, Memory or Problem Solving score of 2 or less).
Those for whom the exercise load may lead to deterioration of physical condition.
Poorly controlled hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg)
Resting heart rate of 100/min or more
Restricted exercise due to impaired cardiac or respiratory function
Lower limb haemodynamic disorder or diabetic peripheral neuropathy with ulceration of the lower limb
Severe joint contracture or deformity
limitation of movement for any other reason.
Physical conditions that may prevent safe practice.
Visual or hearing impairments that interfere with the training.
possibility of incontinence which may contaminate the robot.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo College of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
TEL
0798456881
domen@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Sota |
Organization
Hyogo college of medicine college hospital
Division name
Department of Rehabilitation
Zip code
663-8501
Address
1-1, Mukogawa-cho, Nishinomiya-city, Hyogo
TEL
0798456358
Homepage URL
ksota@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine college hospital
Institute
Department
Personal name
Funding Source
Organization
Hyogo college of medicine college hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
non
Publication of results
Unpublished
Result
URL related to results and publications
non
Number of participants that the trial has enrolled
34
Results
The Balance Exercise Assist Robot (BEAR) was found to improve the Balance Evaluation Systems Test (BESTest) in patients with Parkinson's disease. (BESTest) in patients with Parkinson's disease. The mini-BESTest was also improved in hematology patients after hematopoietic stem cell transplantation (HSCT) with impaired balance. The exploratory study was completed when the target disease and the effect of the treatment were confirmed.
Results date posted
| 2021 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Not stated as not yet published
Participant flow
Not stated as not yet published
Adverse events
non
Outcome measures
BESTest, mini-BESTest
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 03 | Day |
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 14 | 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 | 10 | Month | 25 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052324
