UMIN-CTR Clinical Trial

Public title

Spatial and Qualitative Changes in Bodily Experience and Body Affect After Stroke: A Longitudinal Mixed-Methods Study Using Body Mapping

Acronym

Spatial and Qualitative Changes in Bodily Experience and Body Affect After Stroke: A Longitudinal Mixed-Methods Study Using Body Mapping

Scientific Title

Spatial and Qualitative Changes in Bodily Experience and Body Affect After Stroke: A Longitudinal Mixed-Methods Study Using Body Mapping

Scientific Title:Acronym

Spatial and Qualitative Changes in Bodily Experience and Body Affect After Stroke: A Longitudinal Mixed-Methods Study Using Body Mapping

Region

Japan

Condition

stroke
acute orthopedic conditions

Classification by specialty

Neurosurgery

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to longitudinally elucidate the process of change in bodily experiences and body affect among patients after stroke, from the acute phase through the recovery phase. Particular emphasis will be placed on body affect, a component of body image, to examine how emotions and affective attitudes toward one's own body emerge and change in relation to physical impairments, alterations in bodily sensations, and the meanings attributed to the body.

Basic objectives2

Others

Basic objectives -Others

This study will use qualitative interviews to examine how patients perceive, understand, and relate to their bodies during the acute phase after stroke. It will determine whether body affect is clearly verbalized early or initially appears as bodily experiences such as difficulty moving, heaviness, reduced sensation, and difficulty using the affected body. Body Mapping will quantify the location, intensity, extent, and localization of bodily experiences and body affect, and their associations with VAS scores, physical function, and neuropsychological findings. Qualitative and quantitative data will then be integrated to clarify how bodily experiences develop into body affect, including distrust, disgust, anxiety, burden, protective feelings, attachment, and reintegration.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

At 2 weeks, 1 month, 2 months, 3 months, 4 months, and 5 months after onset

Body-related affect and experience items

Basic emotions:

Anger
Fear
Disgust
Happiness
Sadness
Surprise

Non-basic emotions:
7. Anxiety
8. Love/Affection
9. Depression/Depressed mood
10. Contempt
11. Pride
12. Shame
13. Envy

Perceptual experiences:
14. Heaviness
15. Perceived change in body-part size
16. Numbness
17. Coldness/Warmth
18. Pain

Conceptual understanding and self-related bodily experience:
19. Sense of body ownership
20. Sense of agency
21. Sense of unity with/detachment from the body

Affective states derived from Russell's circumplex model:
22. Tension
23. Worry
24. Unpleasantness
25. Frustration
26. Misery
27. Lethargy
28. Fatigue

Key secondary outcomes

Paper-and-pencil assessments of unilateral spatial neglect (USN): Line Bisection Test and Star Cancellation Test
Functional assessment of unilateral spatial neglect: Catherine Bergego Scale
Assessment of asomatognosia
Frontal lobe function assessment
Deep sensory assessment
Comb and Razor Test
Fluff Test
National Institutes of Health Stroke Scale (NIHSS)
Stroke Impairment Assessment Set (SIAS)
Fugl-Meyer Assessment (FMA) for the upper and lower extremities
Body Mapping
Visual Analogue Scale
Semi-structured interview

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with first-ever stroke

Patients with acute-onset orthopedic conditions

Inclusion criteria

Patients with first-ever stroke

Patients with a first acute-onset orthopedic condition

Ability to communicate verbally

Montreal Cognitive Assessment-Japanese version (MoCA-J) score of 26 or higher

Key exclusion criteria

Severe disturbance of consciousness

Severe cognitive impairment

Severe aphasia that makes it difficult to complete the assessments

Target sample size

50

Name of lead principal investigator

1st name	Masahiro
Middle name
Last name	Ubuyashiki

Organization

Graduate School of Health Sciences, Kio University

Division name

Neurorehabilitation Research Center

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan

TEL

0745-54-1601

Email

f6949665@kio.ac.jp

Name of contact person

1st name	Masahiro
Middle name
Last name	Ubuyashiki

Organization

Graduate School of Health Sciences, Kio University

Division name

Neurorehabilitation Research Center

Zip code

635-0832

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan

TEL

0745-54-1601

Homepage URL

Email

f6949665@kio.ac.jp

Institute

Kio University

Institute

Department

Personal name

Organization

Kio University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Kio University

Address

4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun, Nara, Japan

Tel

0745-54-1601

Email

f6949665@kio.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

06

Month

30

Day

Date of IRB

Anticipated trial start date

2026

Year

07

Month

01

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a prospective longitudinal observational study involving patients with first-ever stroke and patients with acute-onset orthopedic conditions. Consecutive patients who meet the eligibility criteria and provide informed consent will be enrolled. Patients with stroke will be assessed at 2 weeks and at 1, 2, 3, 4, and 5 months after onset. Patients with orthopedic conditions will be assessed at 2 weeks and at 1 and 2 months after onset or surgery. Body Mapping, Visual Analogue Scale, physical function assessments, and neuropsychological assessments will be conducted. Semi-structured interviews will also be conducted at the participating center responsible for the qualitative component. The study will examine the intensity, spatial distribution, and longitudinal changes in body affect and their associations with motor function, sensory impairment, disorders of body cognition, and unilateral spatial neglect. Comparisons between the stroke and orthopedic groups will also be conducted.

Registered date

2026

Year

06

Month

11

Day

Last modified on

2026

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070791