UMIN-CTR Clinical Trial

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

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Functional Ambulation Category (FAC)

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hiroshima University

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

07

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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