UMIN-ICDS Clinical Trial

Public title

Reliability, Validity, and Responsibility of Patient Reported Outcome of Spasticity

Acronym

Reliability, Validity, and Responsibility of PRO of Spasticity

Scientific Title

Reliability, Validity, and Responsibility of Patient Reported Outcome of Spasticity

Scientific Title:Acronym

Reliability, Validity, and Responsibility of PRO of Spasticity

Region

Japan

Condition

central motor paralysis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study is to perform a self-assessment of spasticity in patients with central motor paralysis using the PROs, ArmA and LegA, and to examine their reliability, validity, and responsibility.

Basic objectives2

Others

Basic objectives -Others

Nothing of note

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Reliability: results of ArmA and LegA assessments on admission and the next day in patients at admission
Validation: correlation with modified Ashworth scale (MAS), modified Tardieu scale (MTS), Motor Activity Log-14 (MAL-14), and Fugl-Meyer Assessment (FMA)
Responsibility: changes in functional assessment results at admission and discharge for inpatients, and before botulinum treatment and at outpatient visits 4 to 8 weeks later for outpatients

Key secondary outcomes

MAS, MTS, MAL-14, FMA

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

18

years-old

<=

Age-upper limit

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

18 years of age or older and less than 80 years of age; stable general condition of motor paralysis due to unilateral lesion; no evidence of cognitive decline or severe aphasia and able to understand the study; written consent based on the patient's free will obtained after a thorough explanation of the study; ability to go to the hospital and be hospitalized according to the study schedule.

Key exclusion criteria

Persons with severe dementia, persons with severe psychiatric complications, and others deemed unsuitable by the physician.

Target sample size

100

Name of lead principal investigator

1st name	Michiyuki
Middle name
Last name	Kawakami

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

1608582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Email

michiyukikawakami@hotmail.com

Name of contact person

1st name	Takayuki
Middle name
Last name	Kamimoto

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code

160-8582

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Homepage URL

Email

rw.mssl.720@gmail.com

Institute

Keio University School of Medicine

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Keio University School of Medicine Ethics Committee

Address

35, Shinanomachi, Shinjuku-ku, Tokyo

Tel

0333531211

Email

med-rinri-jimu@adst.keio.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

2023

Year

08

Month

18

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

Open public recruiting

Date of protocol fixation

2023

Year

08

Month

05

Day

Date of IRB

2023

Year

08

Month

07

Day

Anticipated trial start date

2023

Year

08

Month

07

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Inpatients;
Patients admitted to this hospital for the purpose of improving upper extremity function are eligible. Upon admission, functional assessment (MAS, MTS, FMA, MAL-14) performed as part of the usual medical care will be performed, followed by ArmA and LegA evaluation. The next day, another ArmA and LegA evaluation is performed. Rehabilitation is then initiated, and the patient is usually hospitalized for 3 to 4 weeks before being discharged. Prior to discharge, the patient undergoes a functional assessment, which is also performed during the normal course of treatment, followed by an ArmA and LegA evaluation.
Outpatients;
Patients who will receive botulinum therapy as part of their spasticity treatment in our clinic. Prior to botulinum therapy, patients undergo a functional assessment as part of their regular medical care, followed by an ArmA and LegA evaluation. A follow-up outpatient visit is usually scheduled 4 to 8 weeks later. On the same day, a functional assessment will be performed as part of the usual medical care, followed by an ArmA and LegA evaluation.

Registered date

2023

Year

08

Month

17

Day

Last modified on

2023

Year

08

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059250