UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046222
Receipt No. R000052750
Scientific Title Clinical effects of the robot suits Hybrid Assistive Limb assisted gait training in patients with Parkinsonism.: randomized controlled trial
Date of disclosure of the study information 2021/11/29
Last modified on 2021/11/29

* 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 Clinical effects of the robot suits HAL in Parkinsonism.
Acronym Clinical effects of the robot suits HAL in Parkinsonism.
Scientific Title Clinical effects of the robot suits Hybrid Assistive Limb assisted gait training in patients with Parkinsonism.: randomized controlled trial
Scientific Title:Acronym Clinical effects of the robot suits Hybrid Assistive Limb assisted gait training in patients with Parkinsonism.
Region
Japan

Condition
Condition Parkinson's disease
Progressive supranuclear palsy
Corticobasal degeneration
Multiple system atrophy
Vascular Parkinsonism
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of HAL on gait ability and freezing of gait in patients with parkinsonism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Timed up & Go test
Key secondary outcomes 10-m walk test
2 minutes walk test
Berg Balance Scale
MDS-UPDRS part2, part3
Freezing of gait Questionnaire

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Intervention will be provided daily during 4 weeks.
Intervention will be provided 40 minutes including 20 minutes of gait training.
Intervention group, they will be gait training with HAL for 5 days and conventional training other 2 days.
Interventions/Control_2 Control group, they will be conventional training for 7 days.
Control group will be provided 40 minutes of training including 20 minutes of gait training.
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 - Parkinsonism such as bradykinesia, muscle rigidity, and tremor.
-Patients who can understand and agree with study concept.
-Medically stable.
-Body weight under 100kg to wear HAL.
-Patients who can wear HAL.
Key exclusion criteria -The dose of antiparkinson drug will be increase or decrease..
-Having difficulty to stand and walk due to the parkinsonism.
- Cognitive disorder.
-Serious fluctuation of parkinsonism.
-Having difficulty to wear HAL device due to abnormal alignment.
-Neurological or orthopedic disorders of the lower extremity.
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Toru
Middle name
Last name Takeda
Organization Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
Division name Department of Rehabilitation
Zip code 019-2413
Address 352 Gohyakukarita, Kamiyodogawa, Kyouwa, daisen, Akita, Japan.
TEL 018-892-3751
Email takeda-toru@akita-rehacen.jp

Public contact
Name of contact person
1st name Toru
Middle name
Last name Takeda
Organization Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
Division name Department of Rehabilitation
Zip code 019-2413
Address 352 Gohyakukarita, Kamiyodogawa, Kyouwa, daisen, Akita, Japan.
TEL 018-892-3751
Homepage URL
Email takeda-toru@akita-rehacen.jp

Sponsor
Institute Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
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 Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
Address 352 Gohyakukarita, Kamiyodogawa, Kyouwa, daisen, Akita, Japan.
Tel 018-892-3751
Email takeda-toru@akita-rehacen.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

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 29 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 Open public recruiting
Date of protocol fixation
2020 Year 09 Month 30 Day
Date of IRB
2020 Year 10 Month 02 Day
Anticipated trial start date
2020 Year 12 Month 07 Day
Last follow-up date
2022 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 11 Month 29 Day
Last modified on
2021 Year 11 Month 29 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052750

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.