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 | 2024/11/25 13:29:57 |
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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
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
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
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
Completed
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. As of November 2024, the same situation still exists and the study was therefore terminated.
Management information
Registered date
| 2020 | Year | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048636
