UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046222 |
|---|---|
| Receipt number | 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 | 2022/12/07 20:11:54 |
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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
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
takeda-toru@akita-rehacen.jp
Sponsor or person
Institute
Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
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
Akita Prefectural Center for Rehabilitation and Psychiatric Medicine.
Address
352 Gohyakukarita, Kamiyodogawa, Kyouwa, daisen, Akita, Japan.
Tel
018-892-3751
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
28
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
Enrolling by invitation
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
| 2023 | 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
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052750
