UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022335 |
|---|---|
| Receipt number | R000025743 |
| Scientific Title | Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients |
| Date of disclosure of the study information | 2016/05/17 |
| Last modified on | 2017/11/20 13:37:26 |
* 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
Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients
Acronym
Effects of Rehabilitation using the HAL in Stroke Patients
Scientific Title
Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients
Scientific Title:Acronym
Effects of Rehabilitation using the HAL in Stroke Patients
Region
| Japan |
Condition
Condition
Post-stroke patients
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of gait training using a single-leg version of the Hybrid Assistive Limb (HAL) on the paretic side with conventional gait training in individuals with stroke.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional Ambulation Category.
Outcome measures are evaluate prior to training, after 12 sessions (4 weeks), and at 8 and 12 weeks after intervention initiation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
HAL group perform gait training using the HAL 3 times a week with a total of 12 HAL training sessions (4 weeks).
Interventions/Control_2
Conventional group perform conventional gait training (CGT) 3 times a week with a total of 12 CGT training sessions (4 weeks).
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke
Time since stroke onset of within six months
Key exclusion criteria
1) Patients did not consent in this study.
2) Patients not ambulating prior to stroke.
3) Patients with a score of 4 or 5 on the Functional Ambulation Category.
4) Patients with severe disturbance of consciousness (II or III on the Japan Coma Scale).
5) Patients with severe cardiac disease (New York Heart Association Classification of III or IV) .
6) Patients with size limitations for the robotic orthosis.
7) Persons on whom it was impossible to paste an electrode because of skin disease.
8) Persons who had an implanted pacemaker.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisako Yanagi |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan.
TEL
029-853-3496
hyanagi@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Watanabe |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
Address
1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.
TEL
029-853-1131
Homepage URL
watanabe.hiroki.gb@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
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
Address
Tel
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
筑波記念病院(茨城県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 17 | Day |
Last modified on
| 2017 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025743
