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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000022189
Receipt No. R000025565
Scientific Title Clinimetric Properties of the TEMPA with Adapted Guidelines for the Assessment of Arm Activity in Hemiparetic Patients after Stroke
Date of disclosure of the study information 2016/05/03
Last modified on 2019/11/05

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Basic information
Public title Clinimetric Properties of the TEMPA with Adapted Guidelines for the Assessment of Arm Activity in Hemiparetic Patients after Stroke
Acronym Clinimetric Properties of the TEMPA
Scientific Title Clinimetric Properties of the TEMPA with Adapted Guidelines for the Assessment of Arm Activity in Hemiparetic Patients after Stroke
Scientific Title:Acronym Clinimetric Properties of the TEMPA
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study is to assess its clinimetric properties (reliability, validity, and responsiveness) with adapted (Japanese) guidelines for the TEMPA (Test Evaluant les Membres superieurs des Personnes Agees).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Scores of the TEMPA. Scores for each ordinally scaled item range from 0 to -3, scores for the test range from 0 to -39.
Key secondary outcomes Performance time of the TEMPA, the Fugl-Meyer Assessment scores, the Action Research Arm Test, the Box and Block Test, the Wolf Motor Function Test, and the Motor Activity Log.

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with (incomplete) upper extremity paresis resulting from stroke are included.
Key exclusion criteria Exclusion criteria include the following: (1) clear sign of dementia; (2) mental disorder, or aphasia as an obstacle to daily living; (3) excessive pain; (4) the severe end-stage or uncontrolled medical conditions.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Domen
Organization Hyogo College of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798-45-6644
Email office@craseed.org

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Amano
Organization Hospital of Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo 663-8501, Japan
TEL 0798-45-6388
Homepage URL
Email satoru@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization Hyogo College of Medicine
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
Address
Tel
Email

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 兵庫医科大学病院(兵庫県); Hospital of Hyogo College of Medicine

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The number of evaluated cases
 Validity: N=30
 Reliability: N=30
 Responsiveness: N=9
(2018.11.03)
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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 04 Month 18 Day
Anticipated trial start date
2016 Year 05 Month 03 Day
Last follow-up date
2019 Year 05 Month 03 Day
Date of closure to data entry
2019 Year 05 Month 23 Day
Date trial data considered complete
2019 Year 08 Month 07 Day
Date analysis concluded
2019 Year 12 Month 02 Day

Other
Other related information Design: case-control study

Data collection/analysis will start in April 2016 and end in April 2020.

The present study includes a sample of convenience of patients hospitalized at the departments of rehabilitation in a university hospital in Japan speaking Japanese. Patients fulfilling inclusion criteria who agreed to participate will be included. The TEMPA, The Action Research Arm Test (ARAT), Fugl-Meyer Assessment for upper extremity (FMA-UE) and Box and Block Test (BBT), Wolf Motor Function Test, Motor Activity Log (MAL) are employed.

The measurements are directly performed by the trained evaluators. Each task will be described and modeled by the trained therapists, and the patients are not allowed to practice the task.

Two measurements will be performed with a 2-day interval for the patients with acute and sub-acute stroke (<180 days from onset). For the patients with chronic stroke (>=;180 days from onset), two measurements will be performed with a 7-day interval.

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025565

Research Plan
Registered date File name
2016/05/03 実施計画書(No. 2226).docx

Research case data specifications
Registered date File name

Research case data
Registered date File name


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