UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000031551
Receipt No. R000036021
Scientific Title A Study on Training Effect by Robot Suit HAL for Medical Use (Lower Limb Type) - Verification in patients with Parkinson's disease -
Date of disclosure of the study information 2018/03/27
Last modified on 2021/03/04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A Study on Training Effect by Robot Suit HAL for Medical Use (Lower Limb Type)
- Verification in patients with Parkinson's disease -
Acronym A Study on Training Effect by Robot Suit HAL for Medical Use (Lower Limb Type)
- Verification in patients with Parkinson's disease -
Scientific Title A Study on Training Effect by Robot Suit HAL for Medical Use (Lower Limb Type)
- Verification in patients with Parkinson's disease -
Scientific Title:Acronym A Study on Training Effect by Robot Suit HAL for Medical Use (Lower Limb Type)
- Verification in patients with Parkinson's disease -
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of rehabilitation with HAL for Medical Use (Lower Limb Type) in patients with Parkinson's disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II,III

Assessment
Primary outcomes Timed up and Go test
Key secondary outcomes age, gender, height, weight, disease duration, HDS-R, Hoehn & Yahr staging scale, Classification according to clinical diagnostic criteria of Parkinson's disease by MDS, MDSUPDRS part III, freezingof gait questionnaire(FOG-Q), 10m gait speed, step length, Berg Balance Scale(BBS), Video

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 The HAL group takes at first the HAL period followed by the conventional period.
In the HAL period, the patient performs 2 sets of rehabilitation of 5 days training with HAL for 60 minutes followed by 2 days conventional training for 40 minutes. In the conventional period, the patient performs 2 sets of conventional rehabilitation sessions of 5 days training for 60 minutes followed by 2 days training for 40 minutes.
Interventions/Control_2 The conventional group takes at first the conventional period followed by the HAL period.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria -Patients diagnosed as clinically established or clinically probable Parkinson's disease with Movement Disorder Society (MDS) clinical diagnostic criteria
-Patients who meet the stage 2-4 for Hoehn & Yahr staging scale
-Patients who consent with full understanding
-Patients judged that who are stable, and able to stand and walk
-Patients with the ability to stand and walk more than 10 m without assistance
-Patients' weight: 40 to 100 kg
-Patients' heights: 150 to 190 cm
Key exclusion criteria -Patients planned to change the dose of anti-Parkinson's disease drug
-Patients judged as inappropriate for the walking training
-Patients have difficulties with wearing HAL
-Patients have difficulties with putting the electrodes on the skin
-Patients during pregnancy
-Patients have difficulties with understanding instructions
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Ogawa
Organization Nagoya City Rehabilitation Center
Division name Department of Rehabilitation
Zip code 467-8622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL 052-835-3811
Email tets@tcp-ip.or.jp

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Kondou
Organization Nagoya City Rehabilitation Center
Division name Division of Physical Therapy
Zip code 467-8622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL 052-835-3811
Homepage URL
Email physical@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya City Rehabilitation Agency
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel 052-835-3811
Email soumubu@nagoya-rehab.or.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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 27 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 6
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 03 Month 22 Day
Date of IRB
2018 Year 03 Month 27 Day
Anticipated trial start date
2018 Year 03 Month 27 Day
Last follow-up date
2020 Year 07 Month 25 Day
Date of closure to data entry
Date trial data considered complete
2020 Year 02 Month 01 Day
Date analysis concluded
2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 02 Day
Last modified on
2021 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036021

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.