UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044414 |
|---|---|
| Receipt number | 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 22:03:32 |
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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
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
shintaki0704@gmail.com
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050732
