UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042655
Receipt number R000048636
Scientific Title A study of the usefulness of tele-therapy in voluntary speech training for patients with Parkinson's syndrome
Date of disclosure of the study information 2020/12/07
Last modified on 2023/12/04 21:27:37

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Basic information

Public title

A study of the usefulness of tele-therapy in voluntary speech training for patients with Parkinson's syndrome

Acronym

A study of the usefulness of tele-therapy in voluntary speech training for patients with Parkinson's syndrome

Scientific Title

A study of the usefulness of tele-therapy in voluntary speech training for patients with Parkinson's syndrome

Scientific Title:Acronym

A study of the usefulness of tele-therapy in voluntary speech training for patients with Parkinson's syndrome

Region

Japan


Condition

Condition

Parkinson's syndrome

Classification by specialty

Neurology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Tele-teaching using handheld devices is expected to reduce aerosol exposure due to face-to-face contact with the patient, and has the advantage that it can be implemented even in cases where the patient's physical condition makes it difficult to visit the hospital or in remote areas.
Overseas, remote training has been reported to be as effective and useful as conventional voice training.
Remote training is conducted as an outpatient training session using a portable terminal device such as a PC or iPad, and
The purpose of the study was to examine the convenience and training effects.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Voice Testing
100-syllable phonetic reading test
Speech Intelligibility
VHI-J
Training Satisfaction
Independent Training Evaluation
SUS
Remote control information, instructional time, and achievement

Key secondary outcomes



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

50 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

1) Those who are between 50 and 90 years of age at the time of obtaining consent
2) A person who has received oral and written explanations and consent

Key exclusion criteria

1) Difficulty in conducting voluntary training due to cognitive and mental decline
2) Diagnosis by the rehab physician that the patient is at high risk of falling at home
3) Any other items deemed inappropriate by the principal investigator

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Nakayama
Middle name
Last name Keigo

Organization

National Center of Neurology and Psyachiatry

Division name

Department of Rehabilitaion

Zip code

1878551

Address

Kodaira, Tokyo, Ogawahigashi city 4-1-1

TEL

08011603366

Email

stnakayama@ncnp.go.jp


Public contact

Name of contact person

1st name Nakayama
Middle name
Last name Keigo

Organization

National Center of Neurology and Psychiatry

Division name

Department of Rehabilitation

Zip code

1878551

Address

Kodaira, Tokyo, Ogawahigashi city 4-1-1

TEL

0423412711

Homepage URL


Email

stnakayama@ncnp.go.jp


Sponsor or person

Institute

National Center of Neurology and Psychiatry

Institute

Department

Personal name



Funding Source

Organization

Self funding

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

National Center of Neurology and Psychiatry

Address

Kodaira, Tokyo, Ogawahigashi city 4-1-1

Tel

08011603366

Email

stnakayama@ncnp.go.jp


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

国立精神・神経医療研究センター病院


Other administrative information

Date of disclosure of the study information

2020 Year 12 Month 07 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


Results date posted


Results Delayed


Results Delay Reason

The number of patients recruited is low, and research is stagnant. We will continue to recruit prospective patients through academic conferences.

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

2020 Year 09 Month 09 Day

Date of IRB

2020 Year 09 Month 09 Day

Anticipated trial start date

2020 Year 09 Month 10 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

1) Keigo Nakayama, the principal investigator, will explain the study to patients who have requested voice training in the outpatient clinic. If they agree to receive the data, they will be asked to consider whether they would like to receive remote training using a handheld device in addition.
2) Basic information will be cited from the electronic medical record. The pre-training and post-training assessments will be conducted as described below.
3) For the voluntary training group, the pre-training evaluation and training should be conducted in the same way as in the usual outpatient clinic, followed by printed instructions. Post-teaching evaluation and feedback should be conducted approximately one month later.
4) In addition to the instruction in 3), the remote training group will be instructed on how to operate the equipment (verbal + print) and will conduct a 30-minute training session twice a week for 4 weeks using a handheld terminal device (days to be discussed with the subject).
Approximately one month later, post-teaching evaluation and feedback is conducted in the same way as in the usual outpatient clinic.
This will be a sentence completion task. The same content should be done for both the distance learning group and the self-directed training group.
6) Observe the training effects of the distance learning group and the independent training group backward.

The number of patients recruited is low, and research is stagnant. We will continue to recruit prospective patients through academic conferences.
It is still here as of 2023


Management information

Registered date

2020 Year 12 Month 04 Day

Last modified on

2023 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048636


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name