UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055658 |
|---|---|
| Receipt number | R000063420 |
| Scientific Title | Operation of Locobot for Improvement of Postoperative Balance Function in Patients With Cervical Spondylotic Myelopathy |
| Date of disclosure of the study information | 2024/09/28 |
| Last modified on | 2026/01/29 15:30:43 |
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Basic information
Public title
Operation of Locobot for Improvement of Postoperative Balance Function in Patients With Cervical Spondylotic Myelopathy
Acronym
Operation of Locobot for Improvement of Postoperative Balance Function in Patients With Cervical Spondylotic Myelopathy
Scientific Title
Operation of Locobot for Improvement of Postoperative Balance Function in Patients With Cervical Spondylotic Myelopathy
Scientific Title:Acronym
Operation of Locobot for Improvement of Postoperative Balance Function in Patients With Cervical Spondylotic Myelopathy
Region
| Japan |
Condition
Condition
cervical spondylotic myelopathy
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prove the usefulness of locobot as balance training in postoperative rehabilitation of patients with cervical spondylotic myelopathy, to prevent falls and secondary neck disorders, and to contribute to the improvement of manpower shortages in the medical field by introducing robots.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement of the center of gravity of the body in the open eye and close eye standing position
Twice of preoperative and on day 11 or 12 postoperative
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
weight-shifting-based robot control system ("locobot") is used as balance training for postoperative patients with cervical spondylotic myelopathy.
Interventions/Control_2
Conventional methods will be used as balance training for postoperative patients with cervical spondylotic myelopathy.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Patients who are 20 years of age or older at the time of consent; (2) Patients who underwent vertebroplasty during hospitalization; (3) Patients who were able to perform all endpoints before and after surgery; (4) Patients who have been fully informed about their participation in this study, and who have given their free, written consent based on their full understanding.
Key exclusion criteria
(1) Subjects with traumatic spinal cord injury, spinal cord infection, pathological musculoskeletal disease, or other neurological disease (2) Subjects with orthopedic problems that may affect the performance of the assessment items (3) Subjects with balance disorders not caused by CSM such as vestibular dysfunction (4) Subjects who cannot perform all assessment items during preoperative and postoperative assessments (5) Subjects with higher brain dysfunction or cognitive impairment (6) Subjects with other conditions that make them unsuitable as research subjects(5) Subjects with higher brain dysfunction or cognitive impairment (6) Other subjects deemed inappropriate as research subjects by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | hideki |
| Middle name | |
| Last name | arakawa |
Organization
Rehabilitation Unit, University of Miyazaki Hospital, Miyazaki, Japan
Division name
Rehabilitation Unit, University of Miyazaki Hospital, Miyazaki, Japan
Zip code
8891601
Address
5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture
TEL
0985-85-9849
hideki_arakawa@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | tsubasa |
| Middle name | |
| Last name | kawaguchi |
Organization
Rehabilitation Unit, University of Miyazaki Hospital, Miyazaki, Japan
Division name
Rehabilitation Unit, University of Miyazaki Hospital, Miyazaki, Japan
Zip code
8891601
Address
5200 Kihara, Kiyotaka, Miyazaki City, Miyazaki Prefecture
TEL
0985-85-9849
Homepage URL
tsubasa_kawaguchi@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Rehabilitation Unit, University of Miyazaki Hospital, Miyazaki, Japan
Institute
Department
Personal name
Funding Source
Organization
Rehabilitation Unit, University of Miyazaki Hospital, Miyazaki, Japan
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 clinical education support center
Address
5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture
Tel
0985-85-9403
igakubu_kenkyu@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 | 28 | 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
0
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
Terminated
Date of protocol fixation
| 2024 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 29 | 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 | 28 | Day |
Last modified on
| 2026 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063420
