UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062175 |
|---|---|
| Receipt number | R000071098 |
| Scientific Title | An exploratory study on gait training using a combination of the SPIDER and a treadmill |
| Date of disclosure of the study information | 2026/07/08 |
| Last modified on | 2026/07/08 18:02:33 |
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Basic information
Public title
An exploratory study on gait training using a combination of the SPIDER and a treadmill
Acronym
An exploratory study on gait training using a combination of the SPIDER and a treadmill
Scientific Title
An exploratory study on gait training using a combination of the SPIDER and a treadmill
Scientific Title:Acronym
An exploratory study on gait training using a combination of the SPIDER and a treadmill
Region
| Japan |
Condition
Condition
Patients with impaired standing and walking ability
No restriction on sex
Age >= 1 year
Height < 200 cm
Weight < 80 kg
Provided informed consent for gait training using the SPIDER and a treadmill
Currently hospitalized at or receiving outpatient care from the university-affiliated hospital
Classification by specialty
| Medicine in general | Cardiology | Pneumology |
| Neurology | Pediatrics | Orthopedics |
| Rehabilitation medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the clinical safety and feasibility of gait training using The SPIDER in combination with a treadmill and to verify its efficacy. If this study confirms the efficacy of gait training using The SPIDER in combination with a treadmill, it has the potential to become a new gait training method for patients with motor dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vital signs (pre-training, post-training, and 30 min post-training: SpO2, blood pressure, heart rate)
Adverse events (pain, injury, skin lesions, or other complications associated with SPIDER use)
Key secondary outcomes
Motor function assessment (10 m walk test, 2 min walk test, lower limb muscle strength, gross motor function, balance, range of motion, video recording, force plate, posturography, surface electromyography, 3D motion analysis)
ADL and QOL assessment (interview, questionnaire, facial expression, muscle tone)
Biochemical assessment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Gait training using the SPIDER and a treadmill will be performed for up to 30 min per session, approximately twice per week, for 4 weeks.
Interventions/Control_2
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age >= 1 year
Height < 200 cm (SPIDER frame height limitation)
Weight < 80 kg (Although the SPIDER supports higher loads by distributing body weight across multiple elastic cords, a weight limit of 80 kg is set in this study to ensure participant safety.)
Provided informed consent for training using the SPIDER and a treadmill (for children or individuals unable to provide consent, consent will be obtained from a legally authorized representative)
Currently hospitalized at or receiving outpatient care from the university-affiliated hospital
Key exclusion criteria
Severe comorbidities (e.g., cardiac, hepatic, or renal disease)
Considered unsuitable for participation by the attending physician or the investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mayumi |
| Middle name | |
| Last name | Kuroda |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
TEL
029-840-2219
kurodama@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Kuroda |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
TEL
029-840-2219
Homepage URL
kurodama@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
Tel
029-840-2219
kurodama@ipu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 07 | Month | 08 | Day |
Last modified on
| 2026 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071098
