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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name