UMIN-CTR Clinical Trial

Public title

A motivational intervention for stroke rehabilitation: a feasibility study of physical therapy.

Acronym

A motivational intervention for stroke rehabilitation: a feasibility study of physical therapy.

Scientific Title

A motivational intervention for stroke rehabilitation: a feasibility study of physical therapy.

Scientific Title:Acronym

A motivational intervention for stroke rehabilitation: a feasibility study of physical therapy.

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to examine the feasibility of the ARCS model as a motivational intervention for physical therapy in stroke patients.

Basic objectives2

Others

Basic objectives -Others

Feasibility, safety, efficacy

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

1. A questionnaire on the feasibility of this interventional protocol
2. Number of adverse events
3. Number of drop out
4. Functional Independence Measure (FIM)
5. Self-rating Depression Scale (SDS)
6. Apathy Scale (AS)
7. 6-minute walking distance
8. 10 meter walking speed
9. Timed Up and Go test
10. Five scale rating on motivation for rehabilitation
11. Step counts per a week

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Before the intervention, therapists will modify the content of his/her standard physical therapy based on the ARCS motivational model (Keller, 1984, 1987, 2009) in order to facilitate patients' motivation for physical therapy.

The ARCS model is a problem-solving approach to design the motivational aspects of learning environments to stimulate motivation to learn.
Therapists will modify his/her physical therapy according to the following ARCS model' s four criteria. (1) ATTENTION. Does the therapy design to gain patients' attention? (e.g., use surprise or uncertainly to gain interest)? (2) RELEVANCE. Does the therapy design to establish relevance (e.g., provide information for future usefulness)? (3) CONFIDENCE. Does the therapy design for patients to have confidence? (e.g., control of difficulty); (4) SATISFACTION. Does the therapy design for patients to be satisfied or rewarded (e.g., praise)?

As a reference, a list of motivational strategies (see the below list in the section of "Other related information") will be presented to therapists. Therapist may utilize the list or may think of motivational strategies themselves.

Stroke patients will receive 60 minutes/ days of the modified physical therapy for 4 weeks (5 days/week). The content of the revised physical therapy will be reviewed and up-dated every week based on evaluation on patients' motivation.

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

40

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Being between 30-180 days after first-ever stroke
2. Patients with any impairments in lower extremity due to the stroke, such as paralysis, ataxia, and muscle weakness
3. Ability to understand an instruction of the experimental procedure and execute motor and psychological tasks required on this study
4. Ability to walk in daily life without physical contact (walk item of Functional Independence Measure score of 5 or more)
5. Patients who are predicted to hospitalize more than 4 weeks since he/she participated in this study.
6. No other neurologic conditions in addition to stroke
7. Consent to participant in this study

Key exclusion criteria

1. Limited range of motion, musculoskeletal impairments, and/or pain that affect motor tasks
2. Patients with a comfortable walking speed measured by using 10-meter walk test slower than 0.5 m/s at the participation in this study
3. Mental impairment leading to inability to cooperate (attendance to the psychiatry or taking a psychoactive medication)
4. Patients who are considered to be inappropriate to participate in the study

Target sample size

20

Name of lead principal investigator

1st name	Satoshi
Middle name
Last name	Tanaka

Organization

Hamamatsu University School of Medicine

Division name

Psychology

Zip code

431-3125

Address

1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan

TEL

053-453-2111

Email

tanakas@hama-med.ac.jp

Name of contact person

1st name	Satoshi
Middle name
Last name	Tanaka

Organization

Hamamatsu University School of Medicine

Division name

Psychology

Zip code

431-3125

Address

1-20-1 Handayama Higashi-ku, Hamamatsu-city, Japan

TEL

053-453-2111

Homepage URL

Email

tanakas@hama-med.ac.jp

Institute

Seirei Awaji Hospital

Institute

Department

Personal name

Organization

Self-funding
Ministry of education (Japan)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Seirei Awaji Hospital
Shinshu University

Name of secondary funder(s)

Organization

Ethics committee of Hamamatsu University School of Medicine

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan

Tel

053-435-2680

Email

mdrinri@shinshu-u.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

聖隷淡路病院（兵庫県）
Seirei Awaji Hospital (Hyogo)

Date of disclosure of the study information

2019

Year

08

Month

10

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

Terminated

Date of protocol fixation

2019

Year

04

Month

05

Day

Date of IRB

2019

Year

07

Month

02

Day

Anticipated trial start date

2019

Year

08

Month

10

Day

Last follow-up date

2021

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

List of motivational strategies:
01) Control of task difficulty
02) Allowing patient to use a newly acquired skill
03) Applying patient's hobby and preference to exercise and practice task
04) Explaining the necessity of exercise and practice
05) Having a communication which make patient enjoy
06) Active listening
07) Providing opportunities of self-solving
08) Praise
09) Proposing conditions for exchange (e.g. promising to undertake patient's favorite practice after achieving his/her un-favorite practice)
10) Providing a suitable rehabilitation environment
11) Providing exercise and practice with game properties
12) Group rehabilitation
13) Providing medical information
14) Providing practice tasks relating to patient's experience and lifestyle
15) Goal-oriented practice
16) Providing variation of rehabilitation program to sustain interest
17) Recommending the family's presence with the patient during rehabilitation
18) Respect for self-determination
19) Sharing the criteria for evaluation
20) Setting goal
21) Specifying the amount of practice to be achieved
22) Using tools such as diary or graph allowing patient to confirm his/her progress

Registered date

2019

Year

07

Month

30

Day

Last modified on

2021

Year

01

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042798