StrokeNCT03471598
Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke
An observational study of Stroke, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation at 1 site in Taiwan.
Trial summary
Impaired motor function is common after stroke. Individuals with stroke often exhibit synergic pattern that disturb daily function. It is crucial to identify the movement impairment in the clinical settings. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- How many people
- 67 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Feb 2018to 30 Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with first-ever, unilateral cerebral stroke within one month
Who may be able to join
- First-ever, unilateral cerebral stroke within one month
- Being able to maintain standing for more than 10 seconds
Who cannot join
- Could not follow commands
- Deformity or fracture of lower limb
- Less than 20 years old
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City
About this study
Impaired motor function is common after stroke. Individuals with stroke often exhibit synergic pattern that disturb daily function. It is crucial to identify the movement impairment in the clinical settings. Upright Motor Control Test (UMCT) is one of the tests developed to assess the selective movement control and functional strength in people with central nervous disorders. It can be used to reflect the impairment of motor function and evaluate changes of performance after treatment. Yet is little to know the clinimetrics of the UMCT on clinical utility. To date, only few researches explore that UMCT has some construct and criterion validity.
Therefore, this study aims to 1) establish the inter-rater reliability to administer the UMCT. 2) explore the correlation between the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and UMCT. 3). investigate whether the UMCT is able to predict the walking ability in patients with stroke.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Upright Motor Control Test
6-18; higher score means better isolated joint control.
Measured: 1 month
Secondary outcomes (1)
Fugl-Meyer Assessment of Motor Recovery after Stroke
UE scale:0-66; LE scale:0-34; higher score means better motor function.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start6 Feb 2018
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Why it stopped: The COVID-19 pandemic held the candidates and/or participants back to join. The investigators also stopped recruiting for safety concern.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo-Jhen Chen, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
- Investigators
- Bo-Jhen Chen, Principal investigator, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471598
- Sponsor's protocol ID
- 06-XD13-045
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2018
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke
- ClinicalTrials.gov ID
- NCT03471598
- Acronym / sponsor ID
- 06-XD13-045
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The COVID-19 pandemic held the candidates and/or participants back to join. The investigators also stopped recruiting for safety concern.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationUniversity, hospital or other
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 20 Mar 2018 (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.
Impaired motor function is common after stroke. Individuals with stroke often exhibit synergic pattern that disturb daily function. It is crucial to identify the movement impairment in the clinical settings. Upright Motor Control Test (UMCT) is one of the tests developed to assess the selective movement control and functional strength in people with central nervous disorders. It can be used to reflect the impairment of motor function and evaluate changes of performance after treatment. Yet is little to know the clinimetrics of the UMCT on clinical utility. To date, only few researches explore that UMCT has some construct and criterion validity.
Therefore, this study aims to 1) establish the inter-rater reliability to administer the UMCT. 2) explore the correlation between the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and UMCT. 3). investigate whether the UMCT is able to predict the walking ability in patients with stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with first-ever, unilateral cerebral stroke within one month
Key inclusion criteria (2 listed)
- First-ever, unilateral cerebral stroke within one month
- Being able to maintain standing for more than 10 seconds
Key exclusion criteria (3 listed)
- Could not follow commands
- Deformity or fracture of lower limb
- Less than 20 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Upright Motor Control Test
Time frame: 1 month
6-18; higher score means better isolated joint control.
1 secondary outcome
Fugl-Meyer Assessment of Motor Recovery after Stroke
Time frame: 1 month
Results and safety
The study was stopped early (reason given: The COVID-19 pandemic held the candidates and/or participants back to join. The investigators also stopped recruiting for safety concern.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Stroke
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
The Effects of an Augmented Reality-Based Mirror Therapy System in Patients With Stroke
Stroke
Recruiting
A Pivotal Study Evaluating Safety and Effectiveness of Adaptative Tip Catheter in Patients With Acute Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
Acute Ischemic Stroke, Acute Haemorrhagic Stroke
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.
Bo-Jhen Chen principal investigator
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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 Stroke, run by Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation 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 2 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Mar 2022. 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 was stopped early (reason given: The COVID-19 pandemic held the candidates and/or participants back to join. The investigators also stopped recruiting for safety concern.). Results are not available in the source record.
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?
Upright Motor Control Test (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2022.