UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055511 |
|---|---|
| Receipt number | R000061574 |
| Scientific Title | Development and effectiveness of a gait training method using a novel robotic rehabilitation device for persons with gait difficulties. |
| Date of disclosure of the study information | 2024/09/16 |
| Last modified on | 2024/09/16 15:33:25 |
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Basic information
Public title
Development and effectiveness of a gait training method using a novel robotic rehabilitation device for persons with gait difficulties.
Acronym
Development and effectiveness of a gait training method using a novel robotic rehabilitation device for persons with gait difficulties.
Scientific Title
Development and effectiveness of a gait training method using a novel robotic rehabilitation device for persons with gait difficulties.
Scientific Title:Acronym
Development and effectiveness of a gait training method using a novel robotic rehabilitation device for persons with gait difficulties.
Region
| Japan |
Condition
Condition
Disuse syndrome
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effectiveness and safety of gait training using a novel robotic rehabilitation device for patients with disuse syndrome and hospitalized patients who have difficulty walking due to physical or mental functional decline.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m Walking test after 2 weeks of intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Group in addition to the usual rehabilitation intervention, gait training using a new electric wheelchair-type robotic rehabilitation device that provides gait assistance is performed for 10 minutes a day at least 5 days a week.
Interventions/Control_2
Usual rehabilitation intervention group
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
Those who have been diagnosed with disuse syndrome or who have difficulty walking due to decline in physical or mental functions.
Those who are partially assisted in standing up.
Able to walk at least 3 m with the maximum assistance of one caregiver.
Comfortable walking speed is less than 0.8 m/s.
Key exclusion criteria
(1) Patients who have been diagnosed with disuse syndrome before
(2) Patients who had difficulty walking before the onset of the disease
(3) Medical condition that makes moderate-intensity exercise, including gait training, difficult
(4) Patients who are judged to have difficulty in understanding and consenting to the research due to impaired consciousness or higher brain dysfunction (aphasia, cognitive dysfunction, etc.)
(5) Other subjects deemed inappropriate as research subjects by the project leader.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hideki |
| Middle name | |
| Last name | Arakawa |
Organization
Miyazaki University Hospital
Division name
Department of Rehabilitation
Zip code
8891692
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
TEL
0985-85-1510
shougo_maeda@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Maeda |
Organization
Miyazaki University Hospital
Division name
Department of Rehabilitation
Zip code
8891692
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
TEL
0985-85-1510
Homepage URL
shougo_maeda@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Miyazaki University
Institute
Department
Personal name
Funding Source
Organization
Miyazaki University
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
Miyazaki University Hospital
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
Tel
0985-85-1510
shougo_maeda@med.miyazaki-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | 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=R000061574
