UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028042 |
|---|---|
| Receipt number | R000032108 |
| Scientific Title | Effects of gait exercise assist robot (GEAR) on the subjects with chronic stroke |
| Date of disclosure of the study information | 2017/09/01 |
| Last modified on | 2020/11/23 15:24:11 |
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Basic information
Public title
Effects of gait exercise assist robot (GEAR) on the subjects with chronic stroke
Acronym
Effects of gait exercise assist robot (GEAR) on the subjects with chronic stroke
Scientific Title
Effects of gait exercise assist robot (GEAR) on the subjects with chronic stroke
Scientific Title:Acronym
Effects of gait exercise assist robot (GEAR) on the subjects with chronic stroke
Region
| Japan |
Condition
Condition
Subjects with chronic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of gait exercise assist robot on the subjects with chronic stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Physical Cost Index and gait analysis
Key secondary outcomes
10m gait velocity
6-minute walk distance
Timed up to Go
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
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Subjects receives gait training using gait exercise assist robot for 40 min per session, 5 days per week for 4 weeks.
Interventions/Control_2
Subjects receives gait training on treadmil for 40 min per session, 5 days per week for 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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.>6 months duration after stroke
2.Hemiparesis of unilateral, supratentorial, ischemic, or hemorrhage stroke
3.Independent in ground ambulation with or without the use of a unilateral assistive device (standard cane, four-pronged cane) and with or without the use of a an ankle foot orthoses.
4.Independent in treadmil gait training
5.Approval for study participation
Key exclusion criteria
1.Cannot obey instructions of a healer
2.Significant cardiorespiratory/metabolic disease, or orthopedic injury or other neurological
3.Excessive spasticity (defined as Ashworth scale of greater than 3 at any lower limb joint)
4.Size limitations for the harness/counterweight system or robotic orthosis
5.No botulinum toxin therapy in the lower limbs < 4 months prior to enrollment
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo college of Medicine
Division name
Department of rehabilitation medicine
Zip code
663-8501
Address
1-1 Mukogawacho, Nishinomiya, Hyogo 663-8501, Japan
TEL
0798-45-6881
domen@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Ogino |
Organization
Hyogo college of medicine Sasayama medical center
Division name
Department of rehabilitation
Zip code
669-2321
Address
5 Kurooka, Sasayama, Hyogo 669-2321, Japan
TEL
079-552-1181
Homepage URL
sirokuro@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
TOYOTA motor corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo college of Medicine
Address
1-1 Mukogawacho, Nishinomiya, Hyogo 663-8501, Japan
Tel
0798-45-6066
rinken@hyo-med.ac.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
兵庫医科大学ささやま医療センター（兵庫県）/Hyogo college of medicine Sasayama medical center (Hyogo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S1052305720302858?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1052305720302858?via%3Dihub
Number of participants that the trial has enrolled
20
Results
Gait speed was significantly increased at after the intervention and 1-month follow-up compared with before the intervention in the GEAR group. Also, mean changes in TUG and 6-min walk were significantly greater in the GEAR group than in the treadmill group when comparing before with after the intervention.The GRC scale scores were significantly higher after the intervention, at a 1-month and 3-month follow-up assessment than that before the intervention in the GEAR group.
Results date posted
| 2020 | Year | 11 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
GEAR group (n=8, Age: 66.1 (9.6) years, Sex: male 6, female 2, Side of paresis: left 4, right 4, Type of stroke: infarction 1, hemorrhage 7, Time after stroke: 8.0 (5.1) years, Stroke Impairment Assessment Set total lower limb motor score: 8.8 (2.5) scores, Ankle foot orthosis: 8, Assistive device: 6, Mini Mental State Examination: 28.5 (1.9) scores). Treadmill group (n=11, Age: 65.0 (7.7) years, Sex: male 9, female 2, Side of paresis: left 3, right 8, Type of stroke: infarction 4, hemorrhage 7, Time after stroke: 7.1 (4.1) years, Stroke Impairment Assessment Set total lower limb motor score: 8.1 (2.6) scores, Ankle foot orthosis: 7, Assistive device:9, Mini Mental State Examination: 28.5 (1.3) scores).
Participant flow
During the intervention period, one subject was dropped from the GEAR group after the intervention for personal reasons. Additionally, one subject in the GEAR group experienced uncontrolled arrhythmia between the 1-month and 3-month follow-up visits.
Adverse events
No adverse effects were identified for both GEAR and Treadmill intervention.
Outcome measures
All outcome measures were assessed before and after the intervention, at 1-month, and 3-month follow-up assessment. Outcome measures included 10-m walk test (gait parameters), Timed Up and Go (TUG)test, 6-min walk test and Global Rating ofChange (GRC) scales.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 03 | Day |
Last modified on
| 2020 | Year | 11 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032108
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