UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049699 |
|---|---|
| Receipt number | R000056495 |
| Scientific Title | Effect of Backward treadmill gait training on the improvement of walking ability in chronic stroke |
| Date of disclosure of the study information | 2022/12/05 |
| Last modified on | 2024/12/06 13:35:22 |
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Basic information
Public title
Effect of Backward treadmill gait training on the improvement of walking ability in chronic stroke
Acronym
Effect of Backward treadmill gait training on the improvement of walking ability in chronic stroke
Scientific Title
Effect of Backward treadmill gait training on the improvement of walking ability in chronic stroke
Scientific Title:Acronym
Effect of Backward treadmill gait training on the improvement of walking ability in chronic stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of Backward Treadmill Gait Training on Chronic Stroke Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Berg Balance Scale
Before and After Intervention
Key secondary outcomes
Walking parameters: 10m walking test
reaction force meter
3D motion analysis: hip joint angle, knee joint angle, ankle joint angle during walking
Balance function: Mini-BESTest, ABC Scale
2D motion analysis: G.A.I.T
FMA lower extremity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Backward Treadmill Walking
10 days
30 minutes per day
body Weight Support treadmill walking(BWSST)
Interventions/Control_2
Forward Treadmill Walking
10 days
30 minutes per day
body Weight Support treadmill walking(BWSST)
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stroke patients who have had a stroke for more than 6 months after onset
Hemiplegia due to unilateral hemispheric lesion
Patients who can walk 10m or more independently with the use of assistive devices or orthotics
No serious aphasia or cognitive impairment
No contraindications to exercise therapy
Key exclusion criteria
Serious cardiac disease: unstable angina, myocardial infarction of short duration from onset, noncompensated congestive heart failure, acute pulmonary heart, poorly controlled arrhythmia, severe aortic valve stenosis, active myocarditis, endocarditis, etc.
Uncontrolled hypertension
Acute systemic illness or fever
Recent pulmonary embolism, acute pulmonary heart, severe pulmonary hypertension
Complications of severe hepatic or renal dysfunction
Complication of serious orthopedic disease that interferes with lower limb movement
Complication of severe cognitive impairment or severe psychiatric disease
Other metabolic abnormalities (e.g. acute thyroiditis)
Patients with spontaneous pain or inflammation of the hip, knee, or ankle joints
Patients with a history of hip, knee, or ankle joint fracture or traumatic tendon injury
Patients with contractures of the hip, knee, or ankle joints
Patients with impaired consciousness
Patients for whom written consent could not be obtained.
Other patients who are deemed by the treating physician to be unsuitable for enrollment in this clinical trial.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taiyo |
| Middle name | |
| Last name | Kawaguchi |
Organization
Keio University
Division name
Department of Rehabilitation
Zip code
160-8582
Address
35 Shinanomachi, Shinzyuku, Tokyo
TEL
03-3353-1211
t.kawaguchi123@keio.jp
Public contact
Name of contact person
| 1st name | Taiyo |
| Middle name | |
| Last name | Kawaguchi |
Organization
Keio University
Division name
Department of Rehabilitation
Zip code
160-8582
Address
35 Shinanomachi, Shinzyuku, Tokyo
TEL
03-3353-1211
Homepage URL
t.kawaguchi123@keio.jp
Sponsor or person
Institute
Keio University
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Keio University
Department of Rehabilitation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University
Address
35 Shinanomachi, Shinzyuku, Tokyo
Tel
03-3353-1211
t.kawaguchi123@keio.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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056495
