UMIN-CTR Clinical Trial

Public title

Investigation of effective playback speed to improve paralyzed arm in observing video images on a tablet for community-dwelling chronic stroke patients.

Acronym

CDCSTT(community-dwelling chronic stroke tablet trial)

Scientific Title

Investigation of effective playback speed to improve upper extremity function of the affected side of observing video images on a tablet for community-dwelling chronic stroke patients: A Randomized Controlled Trial.

Scientific Title:Acronym

CDCSTT(community-dwelling chronic stroke tablet trial)

Region

Japan

Condition

Chronic stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the effective playback speed to improve the affected upper extremity function in community-dwelling chronic stroke patients by taking motor video images of the unaffected upper extremity on a tablet in advance and observing the video images while placing the tablet on the affected upper extremity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fugl-Meyer Assessment upper extremity.
Time of evaluation: before the intervention, after 4 weeks of the intervention

Key secondary outcomes

Japanese Version of Motor Activity Log
Time of evaluation: before the intervention, after 4 weeks of the intervention

Visual Analog Scale
Time of evaluation: before the intervention, after 4 weeks of the intervention

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

In addition to usual care, observing video images at normal playback speed (1.0x) using a tablet will be conducted as home self-training.
First, the affected forearm is inserted into a self-made tablet box placed on a desk. Next, the size and position of the video image are adjusted to induce a motion illusion, and the degree of motion illusion is assessed using a Visual Analog Scale. The tablet is set to mute so that auditory stimuli are not present during the observing video images. The instruction is "Please observe the video images without moving your hands" and only visual stimuli are used. During video image observation, the upper extremity of the unaffected side should be kept out of sight, such as under a desk. The motion content of the observing video images should include forearm supination/pronation, wrist flexion/extension, finger open/close, opposite thumb and index finger, thumb adduction/abduction, and hook grip. Video images should be observed for 30 minutes per session, 5 times per week, 4 weeks. Breaks will be provided at appropriate intervals. The observation of video images will last for 38 seconds, with the first 3 seconds displaying the exercise on a black screen in text, followed by 5 seconds to adjust the size and position of the video with a still image of the hand, and the remaining 30 seconds for actual video observation. There will be a total of 6 exercises, lasting 3.8 minutes. For individuals who experiencing fatigue or poor attentional focus, it is recommended to maintain the intervention time and instead adjust by incorporating more breaks or shortening the observation time per movement. The number of days and frequency of video observation should be recorded by giving the subject a record sheet. The progress of the observing video images should be checked once per week by phone, at the outpatient, or by visiting the subject's home.

Interventions/Control_2

In addition to usual care, observing video images at high playback speed (2.0x) using a tablet will be conducted as home self-training.
The procedure for intervention is identical to that of normal playback speed groups.

Interventions/Control_3

In addition to usual care, observing video images at low playback speed (0.5x) using a tablet will be conducted as home self-training.
The procedure for intervention is identical to that of normal playback speed groups.

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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) written informed consent to participate in this study,
(2) age 20-80 years
(3) Brunnstrom Recovery Stage 3-6 in the upper extremity
(4) Mini-Mental State Examination score of 24 or higher
(5) ability to maintain a sitting position
(6) Modified Ashworth Scale 3 or less

Key exclusion criteria

(1) presence of muscle hypertonia, pain, limited joint range of motion, or orthopedic disease that significantly interferes with upper extremity function
(2) obvious visual impairment, visual field constriction, or eye movement disorder
(3) obvious cognitive decline or higher brain dysfunction

Target sample size

60

Name of lead principal investigator

1st name	Kubo
Middle name
Last name	Akira

Organization

International University of Health and Welfare

Division name

Department of Physical Therapy, School of Health Sciences at Odawara

Zip code

250-8588

Address

1-2-25 Shiroyama, Odawara-shi, Kanagawa

TEL

0465-21-6500

Email

akubo@iuhw.ac.jp

Name of contact person

1st name	Kanta
Middle name
Last name	Kosuge

Organization

Graduate School of International University of Health and Welfare

Division name

Department of Health and Medical Sciences

Zip code

250-8588

Address

1-2-25 Shiroyama, Odawara-shi, Kanagawa

TEL

0465-21-6500

Homepage URL

Email

22s3049@g.iuhw.ac.jp

Institute

International University of Health and Welfare

Institute

Department

Personal name

Organization

Kanagawa physical therapy association

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

International University of Health and Welfare

Organization

Ethics Committee of International University of Health and Welfare

Address

4-1-26 Akasaka, Minato-ku, Tokyo

Tel

03-5574-3900

Email

rinri-tky@iuhw.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

2024

Year

01

Month

30

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000060813

Publication of results

Unpublished

URL related to results and publications

We only share information that is disclosed on this website.

Number of participants that the trial has enrolled

26

Results

This study analyzed 25 participants. The total score and distal items of the FMA-UE increased significantly in the 1.0x speed group, both from pre to post-intervention and in the between-group comparison. The QOM and VAS increased significantly from pre to post-intervention.

Results date posted

2025

Year

07

Month

04

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

[Over oll]
The mean age was 66.2 +/- 9.82 years, and the participants included 15 males and 10 females.
The stroke types were cerebral infarction in 11 patients, cerebral hemorrhage in 13 patients, and mixed type in 1 patient.
The paralyzed side was the right in 11 patients and the left in 14 patients.
The mean time since stroke onset was 5.0 +/- 4.72 years.
The number of video observation sessions was 19.2 +/- 3.95.
The metronome tempo was 62.6 +/- 7.23 BPM, and the rehabilitation frequency was 2.08 +/- 1.35 sessions per week.
The mean BMI was 24.15 +/- 4.87 kg/m^2.
The mean NIHSS score was 4.76 +/- 1.48.
The mean BRS score was 4.76 +/- 0.97 for the upper limb and 4.64 +/- 0.95 for the hand.
The mean SIAS-S score was 1.96 +/- 0.89 for touch and 2.04 +/- 1.24 for position.
The mean FMA-UE total score was 37.48 +/- 14.68; the proximal score was 25.32 +/- 7.91, and the distal score was 12.16 +/- 7.47.
The mean AOU score was 1.36 +/- 1.03, the QOM score was 1.28 +/- 0.99, and the VAS score was 32.04 +/- 25.33 mm.
The mean MMSE score was 28.0 +/- 1.96.

[Each group]
The age was 65.0 (60.0-71.0) years in the 1.0x group, 68.0 (62.5-71.5) years in the 0.5x group, and 73.5 (65.0-74.0) years in the 2.0x group (p = 0.819).
The numbers of gender (male/female) were 8/1, 2/6, and 5/3, respectively, showing a significant difference among the groups (p = 0.031).
The stroke type (infarction/hemorrhage/mixed) was 4/4/1 in the 1.0x group, 2/6/0 in the 0.5x group, and 5/3/0 in the 2.0x group (p = 0.419).
The affected side (right/left) was 3/6 in the 1.0x group, 4/4 in the 0.5x group, and 4/4 in the 2.0x group (p = 0.778).
The time since stroke onset was 7.0 (2.0-9.0) years in the 1.0x group, 4.5 (3.3-7.3) years in the 0.5x group, and 1.0 (0.8-4.3) years in the 2.0x group (p = 0.165).
The number of observation sessions was 20.0 (19.0-20.0) in the 1.0x group, 20.0 (19.8-20.0) in the 0.5x group, and 20.0 (19.0-20.0) in the 2.0x group (p = 0.741).
The metronome tempo (BPM) was 60.0 (60.0-61.0) in the 1.0x group, 60.0 (60.0-65.0) in the 0.5x group, and 60.0 (60.0-61.3) in the 2.0x group (p = 0.576).
The rehabilitation sessions per week was 1.7 +/- 0.9 in the 1.0x group, 2.1 +/- 1.1 in the 0.5x group, and 2.5 +/- 1.9 in the 2.0x group (p = 0.463).
The BMI was 23.8 (22.8-24.7)m^2 in the 1.0x group, 23.3 (21.1-24.6)m^2 in the 0.5x group, and 23.1 (21.8-24.3)m^2 in the 2.0x groups (p = 0.852).
The NIHSS score was 5.0 (3.0-6.0) in the 1.0x group, 5.0 (4.0-7.0) in the 0.5x group, and 4.0 (4.0-5.3) in the 2.0x group (p = 0.501).
For the Brunnstrom recovery stage (3/4/5/6) of the upper limb were 0/3/3/3 in the 1.0x group, 1/3/2/2 in the 0.5x group, and 1/3/2/2 in the 2.0x group (p = 0.673); for the hand (3/4/5/6), they were 0/4/1/4 in the 1.0x group, 1/3/3/1 in the 0.5x group, and 2/1/5/0 in the 2.0x group (p = 0.456).
For the SIAS-S (0/1/2/3), the touch was 1/1/3/4 in the 1.0x group, 1/2/3/2 in the 0.5x group, and 0/1/6/1 in the 2.0x group (p = 0.638), and the position was 2/0/2/5 in the 1.0x group, 3/0/1/4 in the 0.5x group, and 1/0/3/4 in the 2.0x group (p = 0.878).
The FMA-UE total score was 39.0 (20.5-58.5) in the 1.0x group, 36.0 (25.5-46.8) in the 0.5x group, and 42.0 (24.8-46.5) in the 2.0x group (p = 0.980). The proximal score was 26.7 +/- 10.2, 25.3 +/- 6.1, and 23.9 +/- 7.4, respectively (p = 0.783), and the distal score was 13.0 (4.0-21.5), 13.5 (4.5-16.8), and 16.0 (3.5-18.0), respectively (p = 0.904).
The AOU score was 1.32 +/- 1.12 in the 1.0x group, 1.28 +/- 1.11 in the 0.5x group, and 1.47 +/- 0.98 in the 2.0x group (p = 0.932).
The QOM score was 1.15 +/- 0.96 in the 1.0x group, 1.13 +/- 1.03 in the 0.5x group, and 1.59 +/- 1.05 in the 2.0x group (p = 0.588), and the VAS score was 27.4 +/- 17.4 in the 1.0x group, 41.3 +/- 33.3 in the 0.5x group, and 28.0 +/- 24.6 in the 2.0x group (p = 0.478).
The MMSE score was 29.0 (27.0-30.0) in the 1.0x group, 28.0 (27.8-28.5) in the 0.5x group, and 27.0 (25.8-30.0) in the 2.0x group (p = 0.568).
Values are shown as the median (interquartile range) or mean +/- standard deviation.

Participant flow

26 participants were randomly assigned to 1.0x, 0.5x, and 2.0x groups. One participant in the 0.5x group dropped out due to scheduling difficulties with the post-intervention evaluation. Ultimately, 25 participants were included in both the primary endpoint and ITT analyses, and 21 in the PP analysis.

Adverse events

No serious adverse events were observed during the intervention period. However, one participant complained of mild numbness (1 participant in the 1.0x group) and mood discomfort (1 participant in the 1.0x group and 1 participant in the 2.0x group) during video image observation.

Outcome measures

In ITT analysis of primary outcome, the total scores of FMA-UE showed a statistically significant main effect of time (F (1, 22) = 20.268, p < 0.001) and time-by-group interaction effect (F (2, 22) = 5.159, p = 0.015). Post hoc tests revealed significant within-group differences in both the 1.0x (p < 0.001, 95% CI: 2.339 - 5.661) and 0.5x groups (p = 0.015, 95% CI: 0.488 - 4.012). The distal scores of FMA-UE showed a statistically significant main effect of time (F (1, 22) = 17.243, p < 0.001). An ANCOVA revealed that the change in total scores of FMA-UE was significantly higher in the 1.0x group than in the 2.0x group (p = 0.013, 95% CI: 0.803 - 7.397).
In PP analysis, both the total and distal scores of FMA-UE showed a statistically significant main effect of time (F (1, 18) = 21.827, p < 0.001 for total; F (1, 18) = 25.982, p < 0.001 for distal) and time-by-group interaction effect (F (2, 18) = 7.919, p = 0.003 for total; F (2, 18) = 7.529, p = 0.004 for distal). Post hoc tests revealed significant within-group differences in the 1.0x group for both the total (p < 0.001, 95% CI: 2.980 - 6.687) and distal scores (p < 0.001, 95% CI: 2.445 - 5.222). An ANCOVA revealed that the change in total and distal scores of FMA-UE was significantly higher in the 1.0x group than in the 2.0x group (p = 0.010, 95% CI: 1.118 - 8.168 for total; p = 0.015, 95% CI: 0.670 - 6.455 for distal). In addition, effect sizes for the total and distal scores of FMA-UE, which showed main and interaction effects, were higher in the PP analysis (total score: main effect of time = 0.548, interaction effect = 0.468; distal score: main effect of time = 0.591, interaction effect = 0.455) than in the ITT analysis (total score: main effect of time = 0.480, interaction effect = 0.319; distal score: main effect of time = 0.439, interaction effect = 0.179).
In ITT analysis of secondary outcome, the QOM scores showed a statistically significant main effect of time (F (1, 22) = 6.989, p = 0.015). The VAS showed a statistically significant main effect of time (F (1, 22) = 8.914, p = 0.007). In PP analysis, the QOM scores showed a statistically significant main effect of time (F (1, 18) = 6.812, p = 0.018). The VAS showed a statistically significant main effect of time (F (1, 18) = 10.473, p = 0.005). Although not significantly, VAS indicated higher pre-intervention scores in the 0.5x group and higher post-intervention scores in the 1.0x group.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2023

Year

11

Month

19

Day

Date of IRB

2023

Year

12

Month

13

Day

Anticipated trial start date

2024

Year

01

Month

09

Day

Last follow-up date

2024

Year

07

Month

31

Day

Date of closure to data entry

2024

Year

08

Month

14

Day

Date trial data considered complete

2024

Year

12

Month

12

Day

Date analysis concluded

2025

Year

01

Month

06

Day

Other related information

Registered date

2024

Year

01

Month

24

Day

Last modified on

2025

Year

10

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060813