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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031376
Receipt No. 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

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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
Institute Ichinomiya Nishi Hospital
Institute
Department

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
URL(English) https://upload.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


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