SchizophreniaNCT04941677
Exploring Hand Function in People With Schizophrenia Based on Perspective of Sensorimotor Control
An observational study of Schizophrenia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The study aims to explore the hand function in people with schizophrenia in the chronic stage. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- How many people
- 37 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Sep 2020to 31 Dec 2022
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Adult, Older adult
Study population: Participants with schizophrenia will be recruited from the Department of Internal Medicine in National Cheng Kung University Hospital
Who may be able to join
- Age between 20-65 years old
- Diagnosis with schizophrenia or schizoaffective disorder by psychiatrists according to DSM5.
- Remaining the same antipsychotics and the symptom was stable for at least one month before the study.
- Be able to follow comments and have sufficient cognitive ability assessed by Mini-Mental State Examination score >24
Who cannot join
- Substance abuse or other medical conditions that may affect movements.
- Using other non-antipsychotics that will affect movements in the same period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploration of the Relationships Between Vocational Performances Ans Sensorimotor Factors of Hands in Schizophrenia
The study aims to explore the hand function in people with schizophrenia in the chronic stage.
- Conditions
- Schizophrenia
- Being tested
- no intervention
- Keywords
- hand function, sensorimotor, motor control theory
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia group | No intervention age between 20-65, diagnosed schizophrenia by DSM-5. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semmes Weinstein Monofilaments
Semmes Weinstein Monofilaments is used to assess cutaneous pressure thresholds.
Measured: baseline
Pinch-holding-up-activity test
The pinch apparatus is aims to assess the ability to modulate pinch force to movement-induced load fluctuations in a pinch-holding-up activity (PHUA).
Measured: baseline
Manual Tactile Test
Manual tactile test (MTT) aims to assess the capacity of barognosis, roughness differentiation and stereognosis.
Measured: baseline
Purdue pegboard test
The purpose for Purdue pegboard test is to measure manipulative dexterity including unimanual and bimanual hand dexterity.
Measured: baseline
The Valpar 8 simulates assembly work assessment
Valpar8 simulates the light work and assess the ability of manual dexterity and motor coordination.
Measured: baseline
Secondary outcomes (1)
Self-reported version of the graphic Personal and Social Performance (SRG-PSP)
The self-reported version of the graphic personal and social performance is a self-report scale that aims to assess functional performance.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start17 Sep 2020
- Primary completion31 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 37 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941677
- Sponsor's protocol ID
- B-ER-109-188
- Status last verified
- Apr 2024
- First submitted
- 20 Jun 2021
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lai YJ, Lin YC, Hsu CH, Tseng HH, Lee CN, Huang PC, Hsu HY, Kuo LC. Are the sensorimotor control capabilities of the hands the factors influencing hand function in people with schizophrenia? BMC Psychiatry. 2023 Nov 7;23(1):807. doi: 10.1186/s12888-023-05259-w.
PubMed 37936136
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Relationships Between Vocational Performances Ans Sensorimotor Factors of Hands in Schizophrenia
- ClinicalTrials.gov ID
- NCT04941677
- Acronym / sponsor ID
- B-ER-109-188
- Conditions
- Schizophrenia
- Keywords
- hand function, sensorimotor, motor control theory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to explore the hand function in people with schizophrenia in the chronic stage.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| schizophrenia group | – | Other: no interventionNo intervention age between 20-65, diagnosed schizophrenia by DSM-5. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants with schizophrenia will be recruited from the Department of Internal Medicine in National Cheng Kung University Hospital
Key inclusion criteria (4 listed)
- Age between 20-65 years old
- Diagnosis with schizophrenia or schizoaffective disorder by psychiatrists according to DSM5.
- Remaining the same antipsychotics and the symptom was stable for at least one month before the study.
- Be able to follow comments and have sufficient cognitive ability assessed by Mini-Mental State Examination score >24
Key exclusion criteria (2 listed)
- Substance abuse or other medical conditions that may affect movements.
- Using other non-antipsychotics that will affect movements in the same period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention in this study | Other | schizophrenia group |
Primary outcome
Semmes Weinstein Monofilaments
Time frame: baseline
Semmes Weinstein Monofilaments is used to assess cutaneous pressure thresholds.
Pinch-holding-up-activity test
Time frame: baseline
The pinch apparatus is aims to assess the ability to modulate pinch force to movement-induced load fluctuations in a pinch-holding-up activity (PHUA).
Manual Tactile Test
Time frame: baseline
Manual tactile test (MTT) aims to assess the capacity of barognosis, roughness differentiation and stereognosis.
Purdue pegboard test
Time frame: baseline
The purpose for Purdue pegboard test is to measure manipulative dexterity including unimanual and bimanual hand dexterity.
The Valpar 8 simulates assembly work assessment
Time frame: baseline
Valpar8 simulates the light work and assess the ability of manual dexterity and motor coordination.
1 secondary outcome
Self-reported version of the graphic Personal and Social Performance (SRG-PSP)
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Derived from this study: PubMed 37936136Lai YJ, Lin YC, Hsu CH, Tseng HH, Lee CN, Huang PC, Hsu HY, Kuo LC. Are the sensorimotor control capabilities of the hands the factors influencing hand function in people with schizophrenia? BMC Psychiatry. 2023 Nov 7;23(1):807. doi: 10.1186/s12888-023-05259-w.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semmes Weinstein Monofilaments (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04941677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.