UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054319 |
|---|---|
| Receipt number | R000061051 |
| Scientific Title | Effect of high-speed robot-assisted gait training for patients who have moderate to severe motor paralysis with stroke-a randomized cross-over trial- |
| Date of disclosure of the study information | 2024/05/07 |
| Last modified on | 2024/05/06 12:08:56 |
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Basic information
Public title
Effect of high-speed robot-assisted gait training for patients with stroke
Acronym
Effect of high-speed robot-assisted gait training for patients with stroke
Scientific Title
Effect of high-speed robot-assisted gait training for patients who have moderate to severe motor paralysis with stroke-a randomized cross-over trial-
Scientific Title:Acronym
Effect of high-speed robot-assisted gait training for patients with stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether high-speed robot-assisted gait training using Welwalk is more effective than treadmill training in improving gait and balance ability in stroke patients with severe to moderate motor paralysis and reduced gait speed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comfortable and maximum gait speed
Key secondary outcomes
Fugl-Meyer Assessment, Trunk Impairment Scale, Composite Spasticity Index, Isometric knee extensor strength, Berg Balance Scale, 6-Minute Distance, Timed Up and Go test, Functional Ambulation Categories
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The duration of the intervention will be at least 5 minutes x 2-3sets (10 minutes total), depending on the subject's fatigue, for a period of 8 days (7 days/week). The walking assistance robot will be the WellWalk WW-1000. The swing assist of the paralyzed leg on the Well Walk will be set to 6/6, which is the maximum, and the timing of the start of knee flexion during the swing phase, which is an assist function of the knee joint, the knee flexion angle, and the flexion speed will be adjusted to increase the stride length of the paralyzed leg and to practice walking at a faster speed than walking on a level ground or normal treadmill walking practice. Practice walking at higher speeds than for level walking or normal treadmill walking exercises. The treadmill speed during practice should be increased by 0.05 km/h if the patient can safely walk for more than 1 minute without catching the paralyzed leg; if the paralyzed leg catches even once in 1 minute, the treadmill speed should be decreased immediately by 0.05 km/h. The treadmill speed should be decreased by 3.5 km/h during the 8-day practice period. If the treadmill speed reaches 3.0 km/h during the 8-day practice period, the swing assist is decreased by 1 in the same manner as the treadmill speed.
Interventions/Control_2
Intervention 2 will be a normal treadmill walking exercise. The intervention time will be set at the same time as the gait practice using the walking aid robot, at least 5 minutes x 2-3 sets, depending on the subject's fatigue, and the duration will be 8 days (7 days/week). The treadmill speed during the practice will be gradually increased by 0.05 km/h if the subject can safely walk for more than 1 minute without catching the paralyzed leg. 0.05 km/h treadmill speed will be immediately decreased if the paralyzed leg is caught even once in 1 minute.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Able to walk 10m on level ground with a cane or brace or both with minimal or no assistance
(2) Lower limb motor items of Fugl Meyer Assessment are 22/34 points or less (Moderate to Severe)
(3) Comfortable gait speed is less than 0.6 m/s
(4) Patients whose gait speed is judged to need improvement by the physician and physical therapist
(5) Patients who have obtained consent for the intervention
Key exclusion criteria
Difficulty in understanding instructions due to aphasia or cognitive dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masanari |
| Middle name | None |
| Last name | Yamada |
Organization
Ukai Rehabilitaion Hospital
Division name
Department of Rehabilitation
Zip code
453-0811
Address
4-1 Taikodori, Nakamura-ku, Nagoya 453-0811, Japan
TEL
0524613132
masa-yamada@view.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masanari |
| Middle name | None |
| Last name | Yamada |
Organization
Ukai Rehabilitaion Hospital
Division name
Department of Rehabilitation
Zip code
453-0811
Address
4-1 Taikodori, Nakamura-ku, Nagoya 453-0811, Japan
TEL
0524613132
Homepage URL
masa-yamada@view.ocn.ne.jp
Sponsor or person
Institute
Ukai Rehabilitaion Hospital
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ukai Rehabilitaion Hospital
Address
4-1 Taikodori, Nakamura-ku, Nagoya 453-0811, Japan
Tel
0524613132
masa-yamada@view.ocn.ne.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
| 2024 | Year | 05 | Month | 07 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 05 | Month | 06 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061051
