Reliability, Validity and Responsiveness of the Upright M... | NCT03471598

Studies
Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke

NCT03471598

Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Status

Terminated

Last Update Posted

Mar 16, 2022Actual

Enrollment

67Actual

Phase

Not provided

Conditions

Stroke

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The COVID-19 pandemic held the candidates and/or participants back to join. The investigators also stopped recruiting for safety concern.

Expanded Access Info

Start Date

Feb 6, 2018Actual

Primary Completion Date

Jun 30, 2021Actual

Completion Date

Jun 30, 2021Actual

First Submitted Date

Mar 14, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 20, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2022

Last Update Posted Date

Mar 16, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bo-Jhen Chen, Physical Therapist, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationPrincipal Investigator

Lead Sponsor

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

67Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Upright Motor Control Test	6-18; higher score means better isolated joint control.	1 month

Secondary Outcomes

Measure	Description	Time Frame
Fugl-Meyer Assessment of Motor Recovery after Stroke	UE scale:0-66; LE scale:0-34; higher score means better motor function.	1 month

Other Outcomes

Measure	Description	Time Frame
10 Meter Walk Test	Test the time required to complete 10 meters of walking.	1, 3, 6, and 12 month
6-Minutes-Waking-Test	Record the distance in six-minute walking.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

First-ever, unilateral cerebral stroke within one month
Being able to maintain standing for more than 10 seconds

Exclusion Criteria:

Could not follow commands
Deformity or fracture of lower limb
Less than 20 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults with first-ever, unilateral cerebral stroke within one month

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bo-Jhen Chen	Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation		New Taipei City			Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided