UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053999 |
|---|---|
| Receipt number | R000061586 |
| Scientific Title | Effects of Lumbar-Type Hybrid Assistive Limb on core function for acute patients with cervical spinal cord injury:A randomized control study |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/10/01 02:01:59 |
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Basic information
Public title
Effects of Lumbar-Type Hybrid Assistive Limb on core function for acute patients with cervical spinal cord injury
Acronym
Core exercise with umbar-Type Hybrid Assistive Limb for Acute Cervical Spinal Cord Injury
Scientific Title
Effects of Lumbar-Type Hybrid Assistive Limb on core function for acute patients with cervical spinal cord injury:A randomized control study
Scientific Title:Acronym
Core exercise with umbar-Type Hybrid Assistive Limb for Acute Cervical Spinal Cord Injury
Region
| Japan |
Condition
Condition
cervical spinal cord injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether core exercise using a Lumbar-Type Hybrid Assistive Limb is effective for (1) trunk and lower limb function, (2) sitting and standing ability, and (3) gait recovery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Trunk Assessment Scale for Spinal Cord Injury
Timing of assessment:pre-treatment, 1 week after intervention, and 2 weeks after
Key secondary outcomes
1)Upper Extremity Motor Score
2)Lower Extremity Motor Score
3)Amount of assistance for sitting
4)Amount of assistance for standing
5)1 minute sit to stand test
6)Amount of assistance for gait
7)time to gait practice
8)10m walking test
9)Walking Index for Spinal Cord Injury
10)Barthel Index
11)Japan version of the Spinal Cord Independence Measure self-report
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
physical therapy + Lumber-type Hybrid Assistive Limb
Interventions/Control_2
standard care
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)age ranging 18 to 90
2)first ever cervical cord injury
3)gait difficulty with ASIA Impairment Scale C and D
4)conscious clear
5)No cognitive decline(Mini-Mental State Estimation(MMSE)>24)
6)No orthostatic hypotension or respiratory or circulatory disturbances
7)Independence on ADLs before injury
8)no fracture of target extremities
Key exclusion criteria
1)unconsciousness
2)dementia
3)psychiatric disorder or mental disorders
4)developmental disorder
5)epilepsy
6)unstable physical state
7)Complicated thoracic or lumbar spine fractures requiring a trunk orthosis
8)severe arhythmia or sever heart failure
9)muscular disease
10)not inclusion criteria
11)declined the study
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | yuya |
| Middle name | |
| Last name | ohkubo |
Organization
Saitama medical center
Division name
department of rehabilitation
Zip code
350-8550
Address
1981 kamoda kawagoe-city, saitama, Japan
TEL
049-228-3529
y_ohkubo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | yuya |
| Middle name | |
| Last name | ohkubo |
Organization
Saitama medical center
Division name
department of rehabilitation
Zip code
350-8550
Address
1981 kamoda kawagoe-city, saitama, Japan
TEL
049-228-3529
Homepage URL
y_ohkubo@saitama-med.ac.jp
Sponsor or person
Institute
saitama medical university
Institute
Department
Personal name
Funding Source
Organization
no
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama medical center
Address
1981 kamoda kawagoe-city, saitama, Japan
Tel
049-228-3529
y_ohkubo@saitama-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
埼玉医科大学総合医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 03 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061586
