UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038893
Receipt number R000043996
Scientific Title Effects Of The Combination Of Repetitive Facilitation Exercise and Body Weight Support Treadmill Training On Ambulatory Dysfunction And Paralyzed Lower Limb. -For Outpatients With Chronic Hemiplegia-
Date of disclosure of the study information 2020/01/10
Last modified on 2022/06/23 18:11:59

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Basic information

Public title

Effects Of The Combination Of Repetitive Facilitation Exercise and Body Weight Support Treadmill Training On Ambulatory Dysfunction And Paralyzed Lower Limb. -For Outpatients With Chronic Hemiplegia-

Acronym

Effects Of The Combination Of Repetitive Facilitation Exercise and Body Weight Support Treadmill Training On Ambulatory Dysfunction And Paralyzed Lower Limb. -For Outpatients With Chronic Hemiplegia-

Scientific Title

Effects Of The Combination Of Repetitive Facilitation Exercise and Body Weight Support Treadmill Training On Ambulatory Dysfunction And Paralyzed Lower Limb. -For Outpatients With Chronic Hemiplegia-

Scientific Title:Acronym

Effects Of The Combination Of Repetitive Facilitation Exercise and Body Weight Support Treadmill Training On Ambulatory Dysfunction And Paralyzed Lower Limb. -For Outpatients With Chronic Hemiplegia-

Region

Japan


Condition

Condition

chronic hemiplegia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Improving Lower Limb Paralysis and Ambulatory Dysfunction With Chronic Hemiplegia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Lower Limb Fugl-Meyer-Assessment.Measured at the start, after 6 weeks, after 12 weeks, after 18 weeks, after 24 weeks.

Key secondary outcomes

6-minute walking test, 10m walking test at normal walking speed, 10m walking test at maximum walking speed, Modified Ashworth Scale of paralyzed lower limb, Balance Balance, Functional Impairment Measure, Frenchy Activities Index, acute version F36,espectively measured at the start, after 6 weeks, after 12 weeks, after 18 weeks, after 24 weeks.Mini Mental State Examination measured at the start.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Research design will be carried out in ABA design.Each intervention period will be expected to be six weeks, and the total intervention period is expected to be 18 weeks.Phase A means observations, phase B means interventions.Interventions will be composed of repetitive facilitative therapy and Body weight treadmill training.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Paralysis of lower limb caused by stroke, and walking is independent(FIM walking item 6 to 7).
2) Can understand exercise instructions for repetitive facilitation therapy
3) Outpatient rehabilitation is possible 3 times a week
4) Age is 18 to 80
5) More than 6 months have passed since onset
6) Good general condition

Key exclusion criteria

1) People with limb paralysis
2) If general condition is unstable

Target sample size

28


Research contact person

Name of lead principal investigator

1st name toru/yukitaka
Middle name
Last name nagao/tomoda

Organization

KOBE UNIVERSITY GRADUATE SCHOOL

Division name

HEALTH SCIENCES

Zip code

654-0142

Address

2-10-7 tomogaoka suma ward KOBE

TEL

0787964570

Email

nagao@kobe-u.ac.jp


Public contact

Name of contact person

1st name yukitaka
Middle name
Last name tomoda

Organization

KOBE UNIVERSITY GRADUATE SCHOOL

Division name

HEALTH SCIENCES

Zip code

654-0142

Address

2-10-7 tomogaoka suma ward

TEL

0789502622

Homepage URL


Email

tomotomo19750423111@yahoo.co.jp


Sponsor or person

Institute

KOSEI HOSPITAL

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

KOBE UNIVERSITY GRADUATE SCHOOL

Name of secondary funder(s)



IRB Contact (For public release)

Organization

KOSEI HOSPITAL

Address

1788 Kusakabe doujyo kita ward kobe

Tel

0789502622

Email

tomotomo19750423111@yahoo.co.jp


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

恒生病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2020 Year 01 Month 10 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

25

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

Terminated

Date of protocol fixation

2019 Year 09 Month 16 Day

Date of IRB

2019 Year 10 Month 16 Day

Anticipated trial start date

2019 Year 12 Month 16 Day

Last follow-up date

2023 Year 12 Month 15 Day

Date of closure to data entry


Date trial data considered complete

2023 Year 01 Month 31 Day

Date analysis concluded

2023 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2019 Year 12 Month 15 Day

Last modified on

2022 Year 06 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043996


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name