UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039701 |
|---|---|
| Receipt number | R000045089 |
| Scientific Title | The effect of Intervention Frequency Using Hybrid Assistive Limb (HAL) Single Joint Type on Improvement of Upper Limb Motor Function and Daily Living Movement Ability in Stroke Patients |
| Date of disclosure of the study information | 2020/03/20 |
| Last modified on | 2021/04/17 22:28:07 |
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Basic information
Public title
The effect of Intervention Frequency Using Hybrid Assistive Limb (HAL) Single Joint Type on Improvement of Upper Limb Motor Function and Daily Living Movement Ability in Stroke Patients
Acronym
The effect of Intervention Frequency Using Hybrid Assistive Limb (HAL) Single Joint Type on Improvement of Upper Limb Motor Function and Daily Living Movement Ability in Stroke Patients
Scientific Title
The effect of Intervention Frequency Using Hybrid Assistive Limb (HAL) Single Joint Type on Improvement of Upper Limb Motor Function and Daily Living Movement Ability in Stroke Patients
Scientific Title:Acronym
The effect of Intervention Frequency Using Hybrid Assistive Limb (HAL) Single Joint Type on Improvement of Upper Limb Motor Function and Daily Living Movement Ability in Stroke Patients
Region
| Japan |
Condition
Condition
The patients with acute stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of the frequency of intervention using HAL single joint type on upper limb function and daily activities in patients with acute stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brunnstrom stage
FIM (Functional Independence Measure)
BI(Barthel Index)
MAL(Motor Activity Log)
FMA(Fugl-Meyer Assessment)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)First ever stroke
2)Br.stage of upper limb I-IV
3)enable to understand
Key exclusion criteria
1)Unable to use HAL because of severe orthopedic disease
2)Any other complications
3)Unable to attach electrode because of skin problem
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Iwamoto |
Organization
Araki Neurological Hospital
Division name
Department of Rehabilitation
Zip code
733-0821
Address
2-8-7, Kougokita Hiroshima,Hiroshima
TEL
082-527-1123
yuji_ooooot@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Iwamoto |
Organization
Araki Neurological Hospital
Division name
Department of Rehabilitation
Zip code
733-0821
Address
2-8-7, Kougokita Hiroshima,Hiroshima
TEL
082-527-1123
Homepage URL
yuji_ooooot@yahoo.co.jp
Sponsor or person
Institute
Araki Neurological Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
Araki Neurological Hospital
Address
2-8-7, Kougokita Hiroshima,Hiroshima
Tel
082-527-1123
yuji_ooooot@yahoo.co.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
| 2020 | Year | 03 | Month | 20 | 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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
1) Study design: Cohort study
2) Statistical analysis: A propensity score is calculated by multiple logistic regression analysis, and a pair of a HAL single joint type frequently used group and a less frequently used group is created. To compare and analyze upper limb motor function and daily movement ability between the high frequency group and the low frequency group at the start of HAL and one month after.
Management information
Registered date
| 2020 | Year | 03 | Month | 05 | Day |
Last modified on
| 2021 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045089
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
