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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044414
Receipt No. R000050732
Scientific Title Effects of gait training with the Hybrid Assistive Limb on gait independence in stroke patients: A Systematic Review of Randomized Controlled Trials
Date of disclosure of the study information 2021/07/01
Last modified on 2021/12/03

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Basic information
Public title Effects of gait training with the Hybrid Assistive Limb on gait independence in stroke patients: A Systematic Review of Randomized Controlled Trials
Acronym Effects of gait training with the Hybrid Assistive Limb on gait independence in stroke patients: A Systematic Review of Randomized Controlled Trials
Scientific Title Effects of gait training with the Hybrid Assistive Limb on gait independence in stroke patients: A Systematic Review of Randomized Controlled Trials
Scientific Title:Acronym Effects of gait training with the Hybrid Assistive Limb on gait independence in stroke patients: A Systematic Review of Randomized Controlled Trials
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This review aims to examine the effect of gait training using Hybrid Assistive Limb on gait independence in stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Functional Ambulation Category (FAC)
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (i) Patients diagnosed with hemorrhagic or ischemic stroke
(ii) Patients undergoing gait training with HAL to improve their walking function
(iii) Control group received conventional therapy (e.g. regular physical therapy, Gait training with assistance, etc.)
(iv) Studies were designed as a randomized controlled trial
Key exclusion criteria (i) Patients had been diagnosed with subarachnoid hemorrhage
(ii) Patients examining the effectiveness of HAL in combination with other therapies and robots. (e.g. functional electrostimulation).
Target sample size

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Taki
Organization Hiroshima University
Division name Graduate School of Humanities and Social Sciences
Zip code 739-8524
Address 1-1-1 kagamiyama, Higashi-Hiroshima City, Hiroshima, JAPAN
TEL 080-3498-9194
Email shintaki0704@gmail.com

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Taki
Organization Hiroshima University
Division name Graduate School of Humanities and Social Sciences
Zip code 739-8524
Address 1-1-1 kagamiyama, Higashi-Hiroshima City, Hiroshima, JAPAN
TEL 080-3498-9194
Homepage URL
Email shintaki0704@gmail.com

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization N/A
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 N/A
Address N/A
Tel N/A
Email N/A

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
2021 Year 07 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 03 Month 24 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information A systematic search of the published literature was conducted in PubMed, the Cochrane Library, Physiotherapy Evidence Database (PEDro), and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Studies were collected from inception up to 24 March 2021. All electronic databases were searched with keywords, medical subject headings, and search terms suggested by the individual databases or Boolean phrases joined by and, or, or not. In addition, manual searching was performed to identify the relevant references in these articles.

The articles were screened independently based on title and abstract by two reviewers using predetermined eligibility criteria. Later, full-text copies of articles that were not excluded based on title or abstract were retrieved, and the criteria were reapplied to these studies. Any disagreements at the article screening and selection screening stages were resolved by discussion; decisions were arrived at by the third party in consensus.

The databases listed were searched by the first author. The titles and abstracts of all retrieved results were then screened for eligibility. The first screening process aimed at narrowing down the volume of articles by rejecting all studies that were not relevant or appropriate according to the previously stated criteria. Duplicates were removed. Full-text versions of all relevant articles were evaluated by both authors.



Management information
Registered date
2021 Year 06 Month 03 Day
Last modified on
2021 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050732

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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