UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055415 |
|---|---|
| Receipt number | R000063308 |
| Scientific Title | Study on the effect of Kinesthetic illusion induced by visual stimulation on paraplegic side ankle joint function and gait impairment in patients with hemiplegia in chronic stroke. |
| Date of disclosure of the study information | 2024/09/05 |
| Last modified on | 2024/09/04 13:11:15 |
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Basic information
Public title
Investigating the effects of interventions using visual illusions on paralytic side ankle joint function and gait impairment in stroke patients.
Acronym
Investigating the effects of an intervention using visual illusions for stroke patients.
Scientific Title
Study on the effect of Kinesthetic illusion induced by visual stimulation on paraplegic side ankle joint function and gait impairment in patients with hemiplegia in chronic stroke.
Scientific Title:Acronym
Study on the effects of Kinesthetic illusion induced by visual stimulation in patients with hemiplegia in chronic stroke.
Region
| Japan |
Condition
Condition
Patients with stroke paraplegic
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the effects of kinesthetic illusion induced by visual stimulation using a head-mounted display on the paraplegic lower limb of patients with haemiplegia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 m walking speed
Key secondary outcomes
Number of steps and stride length during a 5 m walk.
Fugl-Meyer Assessment (FMA) lower limb items, coordination, and speed items
Paralyzed lateral ankle joint dorsiflexion angle
Modified Ashworth scale of ankle plantar flexors
Wisconsin gait scale
Likert scale for degree of motor illusion, sense of body ownership and sense of motor subjectivity
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
| Other |
Interventions/Control_1
Normal self-training and dorsiflexion exercises of the paralysed ankle joint for 20 min (phase A). Normal self-training and showing visual stimuli to induce self-motion illusion for 20 minutes per day (phase B). Repeat phases A and B again.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with hemiplegia more than 4 months after stroke onset
2) Patients with a distal lower limb score of 0 to 4 on the Stroke impairment assessment set
3) Patients who can sit in a sitting posture with right and left knee joint flexion of at least 90 degree.
4) Left and right ankle joint other dorsiflexion angle of at least 5 degree at 90 degree knee joint flexion
5) Must be able to walk at least watchful waiting
6) Able to walk at least 10 m with or without a walking aid
7) Age must be at least 18 years
8) Not have received any specific rehabilitation or treatment for paralysis of the lower limbs, such as transcranial magnetic stimulation, repetitive motion acceleration or botulinum toxin, within the past three months.
Key exclusion criteria
1) Persons who are unable to understand the aims and tasks of the study
2) Persons with serious internal disabilities.
3) Persons with visual impairment and unilateral spatial neglect.
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Fuminari |
| Middle name | |
| Last name | Kaneko |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
f-kaneko@tmu.ac.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Tanamachi |
Organization
Tokyo Metropolitan University
Division name
Department of Physical Therapy, Graduate School of Health Sciences
Zip code
116-8551
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
TEL
03-3819-1211
Homepage URL
k-tanamachi@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Other
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
Tokyo Metropolitan University
Address
7-2-10 Higashi-Ogu, Arakawa-ku, Tokyo, Japan
Tel
03-3819-1211
rinri-hs@tmu.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
| 2024 | Year | 09 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2029 | 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 | 09 | Month | 04 | Day |
Last modified on
| 2024 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063308
