UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000028042
Receipt No. 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 (Ver. 8)

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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
Email 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
Email sirokuro@hyo-med.ac.jp

Sponsor
Institute Hyogo college of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032108