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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033340
Receipt No. R000037805
Official scientific title of the study 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 2018/07/09

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Basic information
Official scientific title of the study 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
Title of the study (Brief 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
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 Yuji Iwamoto
Organization Araki Neurological Hospital
Division name Department of Rehabilitation
Address 2-8-7, Kougokita Hiroshima,Hiroshima
TEL 082-527-1123
Email yuji_ooooot@yahoo.co.jp

Public contact
Name of contact person Yuji Iwamoto
Organization Araki Neurological Hospital
Division name Department of Rehabilitation
Address 2-8-7, Kougokita Hiroshima,Hiroshima
TEL 082-527-1123
Homepage URL
Email yuji_ooooot@yahoo.co.jp

Sponsor
Institute Araki Neurological Hospital
Institute
Department

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2016 Year 06 Month 28 Day
Anticipated trial start date
2016 Year 06 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 07 Month 09 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037805

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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