UMIN-CTR Clinical Trial

Public title

Investigation of differences in gait with dorsiflexion angle settings for ankle-foot orthoses

Acronym

Investigation of differences in gait with dorsiflexion angle settings for ankle-foot orthoses

Scientific Title

Changes in Toe Clearance by Adjusting the Dorsiflexion Angle of Ankle-Foot Orthoses

Scientific Title:Acronym

Changes in Toe Clearance by Adjusting the Dorsiflexion Angle of Ankle-Foot Orthoses

Region

Japan

Condition

healthy Individuals and patients with hemiparesis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Ankle-Foot Orthoses often aim to improve gait stability, toe clearance and gait efficiency in hemiplegic patients. The ankle dorsiflexion angle is often set empirically as the initial setting at the start of training, but there are no previous studies on the setting angle and its effect. This study aims to investigate the effect of the dorsiflexion angle of the ankle foot orthosis on gait in normal subjects and hemiplegic patients using a three-dimensional movement analyser.

Basic objectives2

Others

Basic objectives -Others

Stability and efficiency indices during the implementation of walking movements (time-distance factor/Kinematic factor)

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stability and efficiency indices during the implementation of walking movements (time-distance factor/Kinematic factor)

Key secondary outcomes

Movement patterns of each joint, joint angles

Study type

Observational

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Selection criteria for healthy subjects: voluntary healthy subjects at this hospital or at the collaborating institutions.
Selection criteria for hemiplegic patients: patients with stroke hemiplegia who were prescribed an ankle foot orthosis among those who were hospitalised or visited the rehabilitation department as outpatients at this hospital or at a collaborating research centre. Patients who are able to walk stably on a treadmill and have given informed consent for this study.

Key exclusion criteria

1) Those who have difficulty walking for 20 seconds on a treadmill
2) Those who have difficulty following instructions when performing the task due to impaired consciousness or cognitive dysfunction.

Target sample size

80

Name of lead principal investigator

1st name	Yohei
Middle name
Last name	Otaka

Organization

School of Medicine, Fujita Health University

Division name

Department of Rehabilitation Medicine

Zip code

470-1192

Address

1-98, Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture, Japan

TEL

0562-93-2167

Email

yootaka@fujita-hu.ac.jp

Name of contact person

1st name	Hiroshi
Middle name
Last name	Hosokawa

Organization

Musashigaoka Hospital (Tanakakai Medical Corp.)

Division name

Department of Rehabilitation Medicine

Zip code

861-8003

Address

7-15-1 Kusunoki, Kita-ku, Kumamoto City, Kumamoto Prefecture, Japan

TEL

0963391161

Homepage URL

Email

hiroshi.hosokawa@fujita-hu.ac.jp

Institute

School of Medicine, Fujita Health University, Department of Rehabilitation Medicine

Institute

Department

Personal name

Organization

Self-funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fujita Medical University Ethics Review Committee

Address

1-98, Dengakugakubo, Kutsukake-cho, Toyoake City, Aichi Prefecture, Japan

Tel

0562-93-2865

Email

f-irb@fujita-hu.ac.jp

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

2024

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

Open public recruiting

Date of protocol fixation

2023

Year

02

Month

14

Day

Date of IRB

2023

Year

02

Month

14

Day

Anticipated trial start date

2023

Year

03

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The usefulness of ankle-foot orthoses in gait training of stroke paraplegic patients has been reported. However, the influence of the orthosis setting, such as the dorsiflexion angle setting, on gait has not been investigated. In this study, it is of great clinical significance to clarify the effect of adjusting the orthosis angle and other settings using a three-dimensional movement analyser. Previous studies have shown that three-dimensional movement analysis can accurately measure angles and positions even during movement (Ponpipatpaiboon et al, 2018), and the measurement method has scientific validity. This study was an exploratory study, and the number of cases was set as the number of cases that could be performed during the study period based on our practice.

Registered date

2024

Year

07

Month

01

Day

Last modified on

2024

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062668