UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042431 |
|---|---|
| Receipt number | R000048434 |
| Scientific Title | Effects of kinesthetic illusion induced by visual stimulation with increased exercise intensity on ankle function and sit-to-stand movement in patients with subacute stroke hemiparesis |
| Date of disclosure of the study information | 2020/11/12 |
| Last modified on | 2023/11/15 11:07:22 |
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Basic information
Public title
Effects of kinesthetic illusion induced by visual stimulation with increased exercise intensity on ankle function and sit-to-stand movement in patients with subacute stroke hemiparesis
Acronym
Effects of kinesthetic illusion induced by visual stimulation on sit-to-stand movement in patients with stroke hemiparesis
Scientific Title
Effects of kinesthetic illusion induced by visual stimulation with increased exercise intensity on ankle function and sit-to-stand movement in patients with subacute stroke hemiparesis
Scientific Title:Acronym
Effects of kinesthetic illusion induced by visual stimulation on sit-to-stand movement in patients with stroke hemiparesis
Region
| Japan |
Condition
Condition
storke
Classification by specialty
| Neurology | Vascular surgery | Neurosurgery |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of Kinesthetic illusion induced by visual stimulation with increased exercise intensity on the sit-to-stand movement of patients with stroke hemiparesis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sit-to-stand time, weight-bearing symmetry values, trunk forward inclination angle and ankle dorsiflexion angle on the paralyzed side during sit-to-stand
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Experimental group
Kinesthetic illusion induced by visual stimulation using ankle dorsiflexion video with increased exercise intensity by adding resistance
(Intervention time: 5 minutes)
Interventions/Control_2
Control group
Kinesthetic illusion induced by visual stimulation using non-resistive ankle dorsiflexion video
(Intervention time: 5 minutes)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Mini Mental State Examination 24 points or more
2)0 points for consciousness, gaze, visual field, and attention of the National Institutes of Health Stroke Scale (NIHSS)
3)Stroke Impairment Assessment Set (SIAS) distal lower leg score of 1 or higher
Key exclusion criteria
1)Visual impairment that makes it difficult to observe movies
2)Limited range of motion that affects lower limb function
3)Severe aphasia or dementia diagnosed and unable to follow instructions
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Tanabe |
Organization
Kurashiki Rehabilitation Hospital
Division name
Department of rehabilitation
Zip code
710-0834
Address
21, Sasaki, Kurashiki, Okayama
TEL
086-421-3311
mjsstfive@gmail.com
Public contact
Name of contact person
| 1st name | Junpei |
| Middle name | |
| Last name | Tanabe |
Organization
Kurashiki Rehabilitation Hospital
Division name
Department of rehabilitation
Zip code
710-0834
Address
21, Sasaki, Kurashiki, Okayama
TEL
086-421-3311
Homepage URL
mjsstfive@gmail.com
Sponsor or person
Institute
Kurashiki Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Kurashiki Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurashiki Rehabilitation Hospital
Address
21, Sasaki, Kurashiki, Okayama
Tel
086-421-3311
mjsstfive@gmail.com
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
| 2020 | Year | 11 | Month | 12 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/36375318/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36375318/
Number of participants that the trial has enrolled
20
Results
Results showed that the power illusion had a significant effect on sitting retention. The power illusion showed greater subjectivity than the standard illusion, suggesting that improved function of the paralyzed ankle joints reduced sit-to-stand time.
Results date posted
| 2023 | Year | 11 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subjects had 1) first episode of hemiplegia, 2) no orthopedic disease, 3) Stroke Impairment Assessment Set distal lower extremity score of 1 or higher (slight dorsiflexion movements but forefoot not off the floor), 4) ability to sit to stand from a chair to more than watchful waiting without using hands, 5) paralyzed side triceps muscle tone in the lower extremity was at least 1 point on the Modified Ashworth Scale, and 6) had no dementia or higher brain dysfunction.
Translated with www.DeepL.com/Translator (free version)
Participant flow
After screening 286 recruited people with hemiplegia following strokefrom July 2019 to November 2021, 20 people with hemiplegia following stroke were included in the study and randomly assigned togroup A (n = 10) or group B (n = 10).
Adverse events
none in particular
Outcome measures
As primary outcomes, sit-to-stand time and the amount of lower extremity loading during sit-to-stand were assessed. As secondary outcomes, trunk flexion angle, ankle dorsiflexion angle, single joint ankle auto-dorsiflexion angle, and Modified Ashworth Scale were evaluated to assess muscle tone during sit-to-stand.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2022 | 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
| 2020 | Year | 11 | Month | 12 | Day |
Last modified on
| 2023 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048434
