UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031376
Receipt number R000035828
Scientific Title An open label randomized crossover study on hybrid assistive limb (HAL) therapy for Parkinson disease
Date of disclosure of the study information 2018/02/20
Last modified on 2019/02/25 22:13:42

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Basic information

Public title

An open label randomized crossover study on hybrid assistive limb (HAL) therapy for Parkinson disease

Acronym

An efficacy study on hybrid assistive limb (HAL) therapy for Parkinson disease

Scientific Title

An open label randomized crossover study on hybrid assistive limb (HAL) therapy for Parkinson disease

Scientific Title:Acronym

An efficacy study on hybrid assistive limb (HAL) therapy for Parkinson disease

Region

Japan


Condition

Condition

Parkinson disease

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate whether hybrid assistive limb (HAL) therapy is more effective than conventional rehabilitation in improving physical ability of the patients with Parkinson disease.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Primary outcome is walking speed, number of steps, and stride.

Key secondary outcomes

Secondary outcomes were Movement Disorder Society-Unified Parkinson Disease Rating Scale
(MDS-UPDRS), postural instability and gait difficulty score of MDS-UPDRS, Time Up and Go test, Mini Balance Evaluation Systems Test, Functional Reach test, Freezing of Gait Questionnaire, Parkinson disease Questionnaire -39.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In the HAL therapy group, the patients undergo walking training with HAL for 40 minutes a day, 9 times in total, and walking training without HAL for 40 minutes a day, 2 times.

Interventions/Control_2

In the conventional rehabilitation group, the patients undergo walking training without HAL for 60 minutes, 11 times.

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

40 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. The patients meet clinically established or clinically probable cases of the clinical diagnostic criteria of Parkinson disease by Movement Disorder Society
2. Hoehn & Yahr classification is 3 or 4
3. The patients are treated with L-dopa
4. Hospitalization or outpatient visit is possible during the intervention period
5. Written consent has been obtained

Key exclusion criteria

1. Decline in the cognitive function (MMSE 23 points or less)
2. Muscle weakness due to neuromuscular disease
3. The patients cannot walk for 2 minutes
4. Strong posture abnormality (score of '3.13 Posture' in MDS-UPDRS three points or more)
5. Wearing off time of more than 25% of awake time

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Keiji Yamaguchi

Organization

Ichinomiya Nishi Hospital

Division name

Neurology

Zip code


Address

1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan

TEL

0586-48-0077

Email

yamaguchikj@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Kanai

Organization

Ichinomiya Nishi Hospital

Division name

Neurology

Zip code


Address

1, Kaimei-hira, Ichinomiya-city, Aichi, 494-0001, Japan

TEL

0586-48-0077

Homepage URL


Email

masabilliard35@yahoo.co.jp


Sponsor or person

Institute

Ichinomiya Nishi 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


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 02 Month 20 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

Terminated

Date of protocol fixation

2018 Year 01 Month 15 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 20 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 04 Month 30 Day

Date trial data considered complete

2022 Year 05 Month 31 Day

Date analysis concluded

2022 Year 06 Month 30 Day


Other

Other related information



Management information

Registered date

2018 Year 02 Month 19 Day

Last modified on

2019 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035828


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name