UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058023 |
|---|---|
| Receipt number | R000066319 |
| Scientific Title | Effects of high-speed robot-assisted gait training on gait speed in ambulatory stroke patients with moderate to severe hemiplegia: A preliminary multiple single case study |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/30 11:39:03 |
* 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 high-speed robot-assisted gait training on gait speed in ambulatory stroke patients with moderate to severe hemiplegia: A preliminary multiple single case study
Acronym
Effects of high-speed robot-assisted gait training on gait speed in stroke patients: A preliminary study
Scientific Title
Effects of high-speed robot-assisted gait training on gait speed in ambulatory stroke patients with moderate to severe hemiplegia: A preliminary multiple single case study
Scientific Title:Acronym
Effects of high-speed robot-assisted gait training on gait speed in stroke patients: A preliminary study
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 (RAGT) improves gait speed in ambulatory stroke patients with moderate to severe hemiplegia more effectively than conventional treadmill training.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait speed was measured on each training day
Key secondary outcomes
Treadmill speed on each training
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
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
| Other |
Interventions/Control_1
conventional treadmill training (5 minutes x 2 sets x 8 days at a frequency of 7 times/week as part of regular physical therapy).
Interventions/Control_2
High-speed RAGT, which facilitates faster treadmill training by adjusting the force applied to the paretic lower limb to increase step length (5 minutes x 2 sets x 8 days at a frequency of 7 times/week as part of regular physical therapy)
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
(1) Age 20-80 years; (2) first-ever hemiparetic stroke, excluding subarachnoid hemorrhage; (3) time since stroke onset up to six months; (4) Fugl-Meyer Assessment (FMA) lower-limb motor score <= 22/34, indicating moderate to severe motor impairment; (5) ability to walk 10 m with or without assistive devices and at least minimal assistance (FAC >= 2); (6) comfortable walking speed < 0.6 m/s
Key exclusion criteria
(1) unable to perform the assessment tasks due to severe dementia, aphasia, or visual impairment; (2) individuals with significant deformities of the lower limbs or spinal column; (3) individuals with a height outside the range of 140-190 cm or a weight outside the range of 35-100 kg, making it difficult to use the robotic device.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masanari |
| Middle name | |
| Last name | Yamada |
Organization
Ukai Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
4530811
Address
4-1 Taikodori, Nakamura-ku, Nagoya 453-0811, Japan
TEL
052-461-3132
masa-yamada@view.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Masanari |
| Middle name | |
| Last name | Yamada |
Organization
Ukai Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
4530065
Address
4-1 Taikodori, Nakamura-ku, Nagoya 453-0811, Japan
TEL
052-461-3132
Homepage URL
yamadamasa919@gmail.com
Sponsor or person
Institute
Ukai Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 Rehabilitation Hospital
Address
4-1 Taikodori, Nakamura-ku, Nagoya 453-0811, Japan
Tel
052-461-3132
mail@kzan.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
| 2025 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Protocol URL is not available at this time.
Publication of results
Unpublished
Result
URL related to results and publications
results and publications URL is not available at this time.
Number of participants that the trial has enrolled
5
Results
The use of the robot assist function enabled gait training to be conducted at higher speeds than treadmill training. Effect sizes from a single-case design involving five participants indicated that high-speed RAGT led to large improvements in both comfortable and maximum gait speeds.
Results date posted
| 2025 | Year | 05 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
All five participants were in the subacute phase of stroke, with an onset of less than six months. The mean time since onset was 90 +/- 22 days, FAC scores of 3-4, who had moderate to severe motor impairment, as indicated by FMA-motor scores of 14-20.
Participant flow
A convenience sample of five patients with stroke who met the inclusion criteria and were willing to participate in this trial were included in the study. one of the five participants, experienced physical deconditioning unrelated to the intervention on day 8 of Period A, leading to the cancellation of conventional treadmill training on that day. As a result, P5 completed 15 days of training, while the remaining four participants completed 16 days.
Adverse events
No training-related adverse events were observed in any participant.
Outcome measures
Comfortable gait speed, maximum gait speed, treadmill speed during training.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 30 | Day |
Last modified on
| 2025 | Year | 05 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066319
