UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031551 |
|---|---|
| Receipt number | 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 | 2023/04/25 08:40:39 |
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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
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
physical@nagoya-rehab.or.jp
Sponsor or person
Institute
Nagoya City Rehabilitation Agency
Institute
Department
Personal name
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
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
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036021
