UMIN-CTR Clinical Trial

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
Email	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
Email	ksota@hyo-med.ac.jp

Sponsor
Institute	Hyogo college of medicine college hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052324