UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033340 |
|---|---|
| Receipt number | R000037805 |
| Scientific Title | The effect of occupational therapy combined with Hybrid Assistive Limb (HAL) on upper limb function and participation in daily life in patients with acute stroke |
| Date of disclosure of the study information | 2018/07/09 |
| Last modified on | 2020/03/05 00:18:23 |
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Basic information
Public title
The effect of occupational therapy combined with Hybrid Assistive Limb (HAL) on upper limb function and participation in daily life in patients with acute stroke
Acronym
The effect of occupational therapy combined with Hybrid Assistive Limb (HAL) on upper limb function and participation in daily life in patients with acute stroke
Scientific Title
The effect of occupational therapy combined with Hybrid Assistive Limb (HAL) on upper limb function and participation in daily life in patients with acute stroke
Scientific Title:Acronym
The effect of occupational therapy combined with Hybrid Assistive Limb (HAL) on upper limb function and participation in daily life in patients with acute stroke
Region
| Japan |
Condition
Condition
The patients with acute stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of occupational therapy combined with HAL on upper limb function 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)
Key secondary outcomes
Motricity index
Modified Ashworth Scale:MAS
COPM
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The patients will be treated by occupational therapy combined with HAL for 30 minutes, and normal physical therapy, occupational therapy, and speech and language therapy
Interventions/Control_2
The patients will be treated by normal physical therapy, occupational therapy, and speech and language therapy.
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
Inclusion criteria
1)First ever stroke
2)Br.stage of upper limb II-IV
3)enable to understand
Key exclusion criteria
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
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Iwamoto |
Organization
Araki Neurological Hospital
Division name
Department of Rehabilitation
Zip code
Address
2-8-7, Kougokita Hiroshima,Hiroshima
TEL
082-527-1123
yuji_ooooot@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Iwamoto |
Organization
Araki Neurological Hospital
Division name
Department of Rehabilitation
Zip code
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
Address
Tel
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
| 2018 | Year | 07 | Month | 09 | 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
| 2017 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 09 | Day |
Last modified on
| 2020 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037805
